FDA product code NJV: Test, Albumin Cobalt Binding
NJV is the FDA product code for test, albumin cobalt binding. It is a Class II device, regulated under 21 CFR 862.1215 and reviewed by the Clinical Chemistry panel. FDA has cleared 2 510(k) submissions under NJV, from 2 different applicants. The average 510(k) review took 59 days (median 59).
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.
Classification
| Field | Value |
|---|---|
| Device name | Test, Albumin Cobalt Binding |
| Device class | Class II |
| Regulation | 21 CFR 862.1215 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NJV clearance
Top NJV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Inverness Medical Innovations, Inc. | 1 | 2005-12-16 |
| Ischemia Technologies, Inc. | 1 | 2003-02-14 |
Most recent NJV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K053196 | Inverness Medical Innovations, Inc. | ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) | 2005-12-16 | 30 |
| K023824 | Ischemia Technologies, Inc. | ALBUMIN COBALT BINDING TEST (ACB TEST) | 2003-02-14 | 88 |
Recalls for NJV devices
openFDA lists no recalls for product code NJV.
Frequently asked questions
What is FDA product code NJV?
NJV is the FDA product code for test, albumin cobalt binding. It is a Class II device, regulated under 21 CFR 862.1215 and reviewed by the Clinical Chemistry panel.
What device class is NJV?
Class II, regulation 21 CFR 862.1215. Typical premarket route: 510(k).
How long does a 510(k) take for product code NJV?
Across 2 cleared submissions the average was 59 days from receipt to decision (median 59).
Which companies have the most NJV clearances?
Inverness Medical Innovations, Inc. (1); Ischemia Technologies, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NJV
- Run a recall and safety report across every NJV manufacturer
- Watch product code NJV for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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