FDA product code LKJ: Antinuclear Antibody, Antigen, Control
LKJ is the FDA product code for antinuclear antibody, antigen, control. It is a Class II device, regulated under 21 CFR 866.5100 and reviewed by the Immunology panel. FDA has cleared 50 510(k) submissions under LKJ, 1 in the last five years, from 33 different applicants. The average 510(k) review took 88 days (median 56). FDA has posted 13 recalls for LKJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Antinuclear Antibody, Antigen, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5100 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for LKJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 488 |
Compare with all 510(k) review times · Search every LKJ clearance
Top LKJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bio-Rad | 9 | 2003-01-17 |
| Zeus Scientific, Inc. | 3 | 2004-10-08 |
| Elias U.S.A., Inc. | 3 | 1993-09-24 |
| Hycor Biomedical, Inc. | 2 | 1995-12-26 |
| Helix Diagnostics, Inc. | 2 | 1995-12-15 |
28 more applicants have LKJ clearances. See the full list in Caduvo.
Most recent LKJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K210902 | Phadia AB | EliA Ro52, EliA Ro60 | 2022-07-27 | 488 |
| K113610 | Bio-Rad Laboratories | ANA-SCREEN WITH MDSS | 2012-07-09 | 216 |
| K082759 | Phadia US, Inc. | ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY | 2009-04-10 | 200 |
| K081104 | Aesku Diagnostics | AESKULISA ANA HEP-2, REF 30-7115US | 2008-05-02 | 14 |
| K041658 | Bio-Rad Laboratories, Inc. | BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200 | 2004-12-20 | 185 |
Recalls for LKJ devices
13 product recalls in 12 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-11-01.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2019 | 1 |
Frequently asked questions
What is FDA product code LKJ?
LKJ is the FDA product code for antinuclear antibody, antigen, control. It is a Class II device, regulated under 21 CFR 866.5100 and reviewed by the Immunology panel.
What device class is LKJ?
Class II, regulation 21 CFR 866.5100. Typical premarket route: 510(k).
How long does a 510(k) take for product code LKJ?
Across 50 cleared submissions the average was 88 days from receipt to decision (median 56).
Which companies have the most LKJ clearances?
Bio-Rad (9); Zeus Scientific, Inc. (3); Elias U.S.A., Inc. (3); Hycor Biomedical, Inc. (2); Helix Diagnostics, Inc. (2).
Have LKJ devices been recalled?
Yes: 13 product recalls across 12 recall events; the most recent began 2019-11-01.
Next steps
- Run an FDA pathway report with predicate devices for product code LKJ
- Run a recall and safety report across every LKJ manufacturer
- Watch product code LKJ 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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