Recognition List Number: 009 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 Organization: |
| NATIONAL COMMITTEE FOR CLINICAL LABORATORY STANDARDS (NCCLS) |
| 940 WEST VALLEY ROAD |
| SUITE 1400 |
| WAYNE, PA 19087 |
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| CDRH Offices and Divisions Associated with Recognized Standards: |
| (1) | OFFICE OF IN VITRO DIAGNOSTIC DEVICE EVALUATION AND SAFETY (OIVD) | | DIVISION OF CHEMISTRY AND TOXICOLOGY DEVICES (DCTD) |
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| (2) | OFFICE OF COMPLIANCE (OC) |
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| Devices Affected: |
In Vitro Diagnostic devices for the measurement of ionized calcium
In Vitro Diagnostic devives for the calibrating ionized calcium |
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| Processes Affected: |
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| Extent of Recognition: |
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| 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 |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §862.1150 |
Calibrator, Multi-Analyte Mixture |
Class 2 |
JIX |
| §862.1150 |
Calibrator, Primary |
Class 2 |
JIS |
| §862.1150 |
Calibrator, Secondary |
Class 2 |
JIT |
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| 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 |
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| FDA Technical Contact: |
| Carol C. Benson |
| FDA/CDRH/OIVD |
| 2098 GAITHER ROAD, HFZ-440 |
| ROCKVILLE MD 20850 |
| 240/276-0396 |
| Email: carol.benson@fda.hhs.gov |
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