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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 020 FR Publication Date: 09/09/2008 

Part B: Supplementary Information

Recognition Number 7-149: CLSI C24-A3, statistical quality control for quantitative measurements procedures: principles and definitions; approved guideline - third edition. (InVitro Diagnostics)

Date of Standard: 2006. 
Address of Standards Development Organization:
 Clinical Laboratory Standards Institute (CLSI)
  950 West Valley Road
  Suite 2500
  Wayne, PA 19087
 
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
DIVISION OF CHEMISTRY AND TOXICOLOGY DEVICES (DCTD)
(2)OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
DIVISION OF IMMUNOLOGY AND HEMATOLOGY DEVICES (DIHD)
(3)OFFICE OF COMPLIANCE (OC)
Devices Affected:
In Vitro Diagnostic Quality Control
Processes Affected:
510(K)S, PMA, PDP, IDE, HDE
Type of Standard:
 Horizontal, National
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§862.1660 Controls For Blood-Gases, (Assayed And Unassayed) Class 1 JJS
§862.1660 Enzyme Controls (Assayed And Unassayed) Class 1 JJT
§862.1660 Kit, Direct Antigen, Positive Control Class 1 MJZ
§862.1660 Kit, Serological, Positive Control Class 1 MJX
§862.1660 Multi-Analyte Controls, All Kinds (Assayed) Class 1 JJY
§862.1660 Single (Specified) Analyte Controls (Assayed And Unassayed) Class 1 JJX
§862.1660 Urinalysis Controls (Assayed And Unassayed) Class 1 JJW
Relevant Guidance:
Points to Consider for Collection of Data in Support of In Vitro Device Submission for 510(k) Clearance

Guidance for Industry and FDA Staff - Assayed and Unassayed Quality Control Material

Points to Consider for Review of Calibration and Quality Control Labeling for In Vitro Diagnostic Devices/Cover Letter dated 3/14/1996

Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays
FDA Technical Contact:
 Lili Duan
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room 5659
  Silver Spring MD 20993
  301/796-7404
  email: lili.duan@fda.hhs.gov
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