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FDA: standard per metodi diagnostici in vitro   Elenco di messaggi  
Rispondi | Inoltra Messaggio #194 di 246 |
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/Results.CFM

Item # Category Title of Standard Reference Number and Date Effective Date Standards Development Organization
3 InVitro Assessment of the Clinical Accuracy of Laboratory Tests Using Receiver Operating Characteristic (ROC) Plots; Approved Guideline GP10-A 1995 11/03/2006 CLSI NCCLS 
4 InVitro Labeling of Home-Use In Vitro Testing Products; Approved Guideline GP14-A 1996 11/03/2006 CLSI NCCLS 
6 InVitro Specifications for Immunological Testing for Infectious Diseases; Approved Guideline I/LA18-A 1994 02/19/1998 NCCLS 
7 InVitro Assessing the Quality of Radioimmunoassay Systems - Second Edition; Approved Guideline LA1-A2 1994 11/03/2006 CLSI NCCLS 
11 InVitro Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline MM3-A 1995 02/19/1998 NCCLS 
12 InVitro Definitions of Quantities and Conventions Related to Blood pH and Gas Analysis; Approved Standard (1994) C12-A 11/03/2006 CLSI NCCLS 
13 InVitro Performance Characteristics for Devices Measuring PO2 and PCO2 in Blood Samples; Approved Standard (1992) C21-A 11/03/2006 CLSI NCCLS 
15 InVitro Fractional Oxyhemoglobin, Oxygen Content and Saturation, and Related Quantities in Blood: Terminology, Measurement, and Reporting; Approved Guideline (1997) C25-A 11/03/2006 CLSI NCCLS 
16 InVitro Blood Gas Preanalytical Considerations: Specimen Collection, Calibration, and Controls; Approved Guideline (1993) C27-A 11/03/2006 CLSI NCCLS 
18 InVitro Ancillary (Bedside) Blood Glucose Testing C30-A 11/03/2006 CLSI NCCLS 
21 InVitro Erythrocyte Protoporphyrin Testing; Approved Guideline (1996) C42-A 08/14/1998 NCCLS 
22 InVitro Fine-Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline (1996) GP20-A 08/14/1998 NCCLS 
25 InVitro Detection of Abnormal Hemoglobin Using Cellulose Acetate Electrophoresis - Second Edition; Approved Standard (1994) H8-A2 08/14/1998 NCCLS 
26 InVitro Chromatographic (Microcolumn) Determination of Hemoglobin A2; Approved Standard (1989) H9-A 08/14/1998 NCCLS 
27 InVitro Solubility Test to Confirm the Presence of Sickling Hemoglobins - Second Edition; Approved Standard (1995) H10-A2 08/14/1998 NCCLS 
29 InVitro Devices for Collection of Skin Puncture Blood Specimens - Second Edition; Approved Guideline (1990) H14-A2 08/14/1998 NCCLS 
31 InVitro Reference Leucocyte Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard (1992) H20-A 08/14/1998 NCCLS 
34 InVitro Methods for Reticulocyte Counting (Flow Cytometry and Supravital Dyes); Approved Guideline (1997) H44-A 08/14/1998 NCCLS 
35 InVitro One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline (1996) H47-A 08/14/1998 NCCLS 
36 InVitro Quality Assurance for the Indirect Immunoflurescence Test for Autoantibodies to Nuclear Antigen (IF-ANA); Approved Guideline (1996) I/LA2-A 08/14/1998 NCCLS 
37 InVitro Detection and Quantitation of Rubella IGG Antibody: Evaluation and Performance Criteria for Multiple Component Test Products, Specimen Handling, and Use of Test Products in the Clinical Laboratory; Approved Guideline (1997) I/LA6-A 08/14/1998 NCCLS 
38 InVitro Choriogonadotropin Testing: Nomenclature, Reference Preparations, Assay Performance, and Clinical Application; Approved Guideline (1996) I/LA10-A 11/03/2006 CLSI NCCLS 
39 InVitro Assessing the Quality of Systems for Alpha-Fetoprotein (AFP) Assays Used in Prenatal Screening and Diagnosis of Neural Tube Defects; Approved Guideline (1997) I/LA17-A 11/03/2006 CLSI NCCLS 
40 InVitro Specifications for Immunological Testing for Infectious Diseases; Approved Guideline (1994) I/LA18-A 08/14/1998 NCCLS 
41 InVitro Primary Reference Preparations Used to Standardize Calibration of Immunochemical Assays for Serum Prostate Specific Antigen (PSA); Approved Guideline (1997) I/LA19-A 08/14/1998 NCCLS 
42 InVitro Evaluation Methods and Analytical Performance Characteristics of Immunological Assays for Human Immunoglobulin E (IgE) Antibodies of Defined Allergen Specificities; Approved Guideline (1997) I/LA20-A 08/14/1998 NCCLS 
43 InVitro Blood Collection on Filter Paper for Neonatal Screening Programs; Approved Standard - Third Edition (1997) LA4-A3 11/03/2006 CLSI NCCLS 
46 InVitro Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Approved Standard (1997) M27-A 08/14/1998 NCCLS 
48 InVitro Blood Alcohol Testing in the Clinical Laboratory; Approved Guideline (1997) T/DM6-A 11/03/2006 CLSI NCCLS 
49 InVitro Performance Goals for the Internal Quality Control of Multichannel Hematology Analyzers; Approved Standard H26-A 05/03/1999 NCCLS 
50 InVitro Glossary and Guidance for Immunodiagnostic Procedures, Reagents, and Reference Materials - Second Edition, Approved Guideline D11-A2 05/03/1999 NCCLS 
51 InVitro Using Proficiency Testing (PT) to Improve the Clinical Laboratory; Approved Guideline GP 27-A 11/03/2006 CLSI NCCLS 
52 InVitro Terminology and Definitions for use in NCCLS Documents; Approved Standard NRSCL 8-A 11/03/2006 CLSI NCCLS 
53 InVitro Continuous Quality Improvement: Essential Management Approaches; Approved Guideline GP 22-A 05/03/1999 NCCLS 
54 InVitro Immunoprecipitin Analyses: Procedures for Evaluating the Performance of Materials - Second Edition; Approved Guideline D12-A2 10/31/2005 CLSI 
55 InVitro Procedures for the Handling and Processing of Blood Specimens; Approved Guideline -- Second Edition H18-A2 11/03/2006 CLSI NCCLS 
58 InVitro Procedures for the Collection of Arterial Blood Specimens; Approved Standard - Third Edition H11-A3 10/01/2001 NCCLS 
59 InVitro Laboratory Automation: Bar Codes for Specimen Container Identification; Approved Standard AUTO2-A 11/03/2006 CLSI NCCLS 
60 InVitro Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard AUTO1-A 10/01/2001 NCCLS 
61 InVitro Laboratory Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard AUTO3-A 10/01/2001 NCCLS 
62 InVitro Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard AUTO4-A 05/31/2002 NCCLS 
63 InVitro Laboratory Automation: Electromechanical Interfaces; Approved Standard AUTO5-A 05/31/2002 NCCLS 
64 InVitro Point-of-Care Connectivity; Approved Standard POCT1-A 05/31/2002 NCCLS 
67 InVitro Evaluation of Matrix Effects; Approved Guideline EP14-A 03/11/2003 NCCLS 
68 InVitro Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring; Approved Guideline - Second Edition GP19-A2 03/11/2003 NCCLS 
70 InVitro Procedures and Devices for the Collection of Diagnostic Blood Specimens by Skin Puncture; Approved Standard - Fourth Edition H4-A4 03/11/2003 NCCLS 
71 InVitro Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard - Third Edition H15-A3 03/11/2003 NCCLS 
72 InVitro Clinical Application of Flow Cytometry: Quality Assurance and Immunophenotyping of Lymphocytes; Approved Guideline H42-A 03/11/2003 NCCLS 
73 InVitro Clinical Evaluation of Immunoassays; Approved Guideline I/LA21-A 03/11/2003 NCCLS 
74 InVitro Protocols for Evaluating Dehydrated Mueller-Hinton Agar; Approved Standard M6-A 03/11/2003 NCCLS 
76 InVitro Laboratory Diagnosis of Blood-borne Parasitic Diseases; Approved Guideline M15-A 03/11/2003 NCCLS 
77 InVitro Quality Assurance for Commerically Prepared Microbiological Culture Media - Second Edition; Approved Standard M22-A2 03/11/2003 NCCLS 
78 InVitro Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters; Approved Guideline M23-A2 03/11/2003 NCCLS 
79 InVitro Procedures for the Recovery and Identification of Parasites from the Intestinal Tract; Approved Guideline M28-A 03/11/2003 NCCLS 
80 InVitro Molecular Diagnostic Methods for Genetic Diseases; Approved Guideline MM1-A 03/11/2003 NCCLS 
81 InVitro How to Define and Determine Reference Intervals in the Clinical Laboratory; Approved Guideline - Second Edition C28-A2 03/11/2003 NCCLS 
82 InVitro Sweat Testing: Collection and Quantitative Analysis; Approved Guideline - Second Edition C34-A2 03/11/2003 NCCLS 
83 InVitro Blood Gas and pH Analysis and Related Measurements; Approved Guideline C46-A 03/11/2003 NCCLS 
84 InVitro Stability Testing of In Vitro Diagnostic Reagents 13640 06/01/2004 CEN 
85 InVitro Statistical Quality Control for Quantitative Measurements: Principles and Definitions: Approved Guideline - Second Edition (1999): ISBN 1-56238-371-X C24-A2 03/08/2004 NCCLS 
86 InVitro Standardization of Sodium and Potassium Ion Selective Electrode Systems to the Flame Photometric Reference Method; Approved Standard (2000) ISBN 1-56238-406-6 C29-A2 03/08/2004 NCCLS 
87 InVitro Ionized Calcium Determinations: Precollection Variables, Specimen Choice, Collection, and Handling; Approved Guideline - Second Edition (2001); ISBN 1-56238-436-8 C31-A2 03/08/2004 NCCLS 
88 InVitro Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Measurement Procedures; Approved Guideline C37-A 03/08/2004 NCCLS 
89 InVitro A Designated Comparison Method for the Measurement of Ionized Calcium in Serum; Approved Standard (2000) ISBN1-56238-398-1 C39-A 03/08/2004 NCCLS 
90 InVitro Clinical Applications of Flow Cytometry: Immunophenotyping of Leukemic Cells; Approved Guideline H43-A 03/08/2004 NCCLS 
92 InVitro Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline EP09-A2 03/08/2004 NCCLS 
93 InVitro Preliminary Evaluation of Quantitative Clinical Laboratory Methods; Approved Guideline EP10-A2 03/08/2004 NCCLS 
94 InVitro User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline EP12-A 03/08/2004 NCCLS 
95 InVitro User Demonstration of Performance for Precision and Accuracy; Approved Guideline EP15-A 03/08/2004 NCCLS 
96 InVitro Quality Management for Unit-Use Testing; Approved Guideline EP18-A 03/08/2004 NCCLS 
97 InVitro Urinalysis and Collection, Transportation, and Preservation of Urine Specimens - Second Edition; Approved Guideline GP16-A2 03/08/2004 NCCLS 
98 InVitro Immunoglobulin and T-Cell Receptor Gene Rearrangement Assays; Approved Guideline-2nd Edition MM2-A 06/01/2004 NCCLS 
99 InVitro Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline MM5-A 06/01/2004 NCCLS 
100 InVitro In vitro diagnostic test systems - Requirements for in vitro whole blood glucose monitoring systems intended for use by patients for self testing in management of diabetes mellitus, First Edition 2003-05-01, Approved 15197 06/01/2004 ISO 
101 InVitro Assays of vonWillebrand Factor Antigen and Ristocetin Cofactor Activity; Approved Guideline H51-A 06/01/2004 NCCLS 
102 InVitro Tubes and Additives for Venous Blood Specimen Collection; Approved Standard H1-A5 09/01/2004 NCCLS 
103 InVitro Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard H3-A5 09/01/2004 NCCLS 
104 InVitro Procedure for Determining Packed Cell Volume by the Microhematocrit Method - Second Edition; Approved Standard - Third Edition H7-A3 09/01/2004 NCCLS 
105 InVitro Procedure for the Determination of Fibrinogen in Plasma; Approved Guideline Second Edition H30-A2 09/01/2004 NCCLS 
106 InVitro Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard - 8th Edition M2-A8 09/01/2004 NCCLS 
107 InVitro Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically`; Approved Standard - Sixth Edition M11-A6 09/01/2004 NCCLS 
108 InVitro Methods for Antimicrobial Susceptibility Tests of Anaerobic Bacteria; Approved Standard -- Sixth Edition M7-A6 09/01/2004 NCCLS 
109 InVitro Laboratory Automation: Data Content for Specimen Identification; Approved Standard AUTO7-A 10/31/2005 CLSI 
110 InVitro Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition EP5-A2 10/31/2005 CLSI 
111 InVitro Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays; Approved Guideline - Fourth Edition H21-A4 10/31/2005 CLSI 
112 InVitro Point-of-Care Monitoring of Anticoagulation Therapy; Approved Guideline H49-A 10/31/2005 CLSI 
113 InVitro Assessing the Quality of Immunoassay Systems: Radioimmunoassays, and Enzyme, Fluorescence, and Luminescence Immunoassays; Approved Guidelines I/LA23-A 10/31/2005 CLSI 
114 InVitro Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems LIS01-A 10/31/2005 CLSI 
115 InVitro Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems; Approved Standard-Second Edition LIS02-A2 10/31/2005 CLSI 
116 InVitro Standard Guide for Selection of a Clinical Laboratory Information Management System LIS03-A 10/31/2005 CLSI 
117 InVitro Standard Guide for Documentation of Clinical Laboratory Computer Systems LIS04-A 10/31/2005 CLSI 
118 InVitro Standand Specification for Transferring Clinical Observations Between Independent Computer Systems LIS05-A 10/31/2005 CLSI 
119 InVitro Standard Practice for Reporting Reliability of Clinical Laboratory Information Systems LIS06-A 10/31/2005 CLSI 
120 InVitro Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory LIS07-A 10/31/2005 CLSI 
121 InVitro Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems LIS08-A 10/31/2005 CLSI 
122 InVitro Standard Guide for Coordination of Clinical Laboratory Services within the Electronic Health Record Environment and Networked Architectures LIS09-A 10/31/2005 CLSI 
123 InVitro Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine MM9-A 10/31/2005 CLSI 
124 InVitro Fluorescence Calibration and Quantitative Measurement of Fluorescence Intensity; Approved Guideline I/LA24-A 11/03/2006 CLSI NCCLS 
125 InVitro Procedures for the Recovery and Identification of Parasites from the Intestinal Tract; Approved Guideline M28-A2, Volume 25, No. 16 11/03/2006 CLSI NCCLS 
126 InVitro Susceptibility Testing of Mycobacteria, Nocardiae and other Aerobic Actinomycetes M24-A, Volume 23, No.18: 11/03/2006 CLSI NCCLS 
127 InVitro Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition EP 7-A2 05/21/2007 NCCLS 
128 InVitro Evaluation of Matrix Effects; Approved Guideline - Second Edition EP14-A2 05/21/2007 CLSI 
129 InVitro Quality Control of Microbiological Transport Systems M40-A 05/21/2007 CLSI 
 
 

Database Updated May 21, 2007



Mer 4 Lu 2007 9:27 pm

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http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/Results.CFM Item # Category Title of Standard Reference Number and Date Effective Date Standards... 		Marco Pradella
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