Test, Albumin Cobalt Binding
NJV is the FDA product code for Test, Albumin Cobalt Binding, a class II device type, regulated under 21 CFR 862.1215. FDA's definition for this code reads: "The Albumin Cobalt Binding Test is a quantitative in vitro diagnostic test used on human serum that detects Ischemia Modified Albumin by measuring the cobalt binding capacity of albumin in human serum. IMA is intended for use in conjunction with other tests such as ECG and cardiac troponin as an aid to the short term...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- NJV
- Device name
- Test, Albumin Cobalt Binding
- FDA definition
- The Albumin Cobalt Binding Test is a quantitative in vitro diagnostic test used on human serum that detects Ischemia Modified Albumin by measuring the cobalt binding capacity of albumin in human serum. IMA is intended for use in conjunction with other tests such as ECG and cardiac troponin as an aid to the short term risk stratification of patients presenting with chest pain suggestive of cardiac origin.
- Regulation
- 21 CFR 862.1215
- Device class
- Class II
- Review panel
- Clinical Chemistry
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 2
- Ingested recalls
- 0
Clearances, product code NJV
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2003 | 1 |
| 2005 | 1 |
Applicants with the most clearances
Product code NJV| Applicant | Clearances |
|---|---|
| Inverness Medical Innovations, Inc. | 1 |
| Ischemia Technologies, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code NJV.
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