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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 7-87: NCCLS C31-A2, ionized calcium determinations: precollection variables, specimen choice, collection, and handling; approved guideline - second edition (2001); isbn 1-56238-436-8. (InVitro Diagnostics)

Date of Standard: 2001. 
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
Processes Affected:
510(K), PMA, PDP, IDE, HDE
Type of Standard:
 Vertical, National
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
Relevant Guidance:
Points to Consider for Collection of Data in Support of In Vitro Device Submissions for 510(k) Clearance, 09/26/94
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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