FDA product code NBS: Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)
NBS is the FDA product code for autoantibodies, lkm-1 (liver/kidney microsome, type 1). It is a Class II device, regulated under 21 CFR 866.5660 and reviewed by the Immunology panel. FDA has cleared 3 510(k) submissions under NBS, from 2 different applicants. The average 510(k) review took 260 days (median 264).
Classification
| Field | Value |
|---|---|
| Device name | Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1) |
| Device class | Class II |
| Regulation | 21 CFR 866.5660 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for NBS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 264 |
Compare with all 510(k) review times · Search every NBS clearance
Top NBS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Inova Diagnostics, Inc. | 2 | 2017-09-06 |
| Euroimmun US | 1 | 2012-09-11 |
Most recent NBS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K163538 | Inova Diagnostics, Inc. | QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls | 2017-09-06 | 264 |
| K112223 | Euroimmun US | EUROIMMUN ANTI-LKM-1 ELISA(LGG) | 2012-09-11 | 406 |
| K000535 | Inova Diagnostics, Inc. | QUANTA LITE LKM-1 ELISA | 2000-06-07 | 111 |
Recalls for NBS devices
openFDA lists no recalls for product code NBS.
Frequently asked questions
What is FDA product code NBS?
NBS is the FDA product code for autoantibodies, lkm-1 (liver/kidney microsome, type 1). It is a Class II device, regulated under 21 CFR 866.5660 and reviewed by the Immunology panel.
What device class is NBS?
Class II, regulation 21 CFR 866.5660. Typical premarket route: 510(k).
How long does a 510(k) take for product code NBS?
Across 3 cleared submissions the average was 260 days from receipt to decision (median 264).
Which companies have the most NBS clearances?
Inova Diagnostics, Inc. (2); Euroimmun US (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NBS
- Run a recall and safety report across every NBS manufacturer
- Watch product code NBS 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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