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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 009 FR Publication Date: 03/08/2004 

Part B: Supplementary Information

Recognition Number 7-89: NCCLS C39-A, a designated comparison method for the measurement of ionized calcium in serum; approved standard (2000) isbn1-56238-398-1. (InVitro Diagnostics)

Date of Standard: 2000. 
Address of Standards Development Organization:
 National Committee for Clinical Laboratory Standards (NCCLS)
  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 COMPLIANCE (OC)
Devices Affected:
In Vitro Diagnostic devices for the measurement of ionized calcium
In Vitro Diagnostic devives for the calibrating ionized calcium
Processes Affected:
510(K), PMA, PDP, IDE
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§862.1145 Atomic Absorption, Calcium Class 2 JFN
§862.1145 Azo Dye, Calcium Class 2 CJY
§862.1145 Cresolphthalein Complexone, Calcium Class 2 CIC
§862.1145 Electrode, Ion Specific, Calcium Class 2 JFP
§862.1150 Calibrator, Multi-Analyte Mixture Class 2 JIX
§862.1150 Calibrator, Primary Class 2 JIS
§862.1150 Calibrator, Secondary Class 2 JIT
Relevant Guidance:
Points to consider for collection of data in support of in-vitro device submissions for 510(k), clearing guidance for industry - abbreviated 510(k) submissions for in vitro diagnostic calibrators
FDA Technical Contact:
 Meshaun Payne
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room 5650
  Silver Spring MD 20993
  301/796-6668
  email: meshaun.payne@fda.hhs.gov
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