FDA product code LJM: Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
LJM is the FDA product code for antinuclear antibody (enzyme-labeled), antigen, controls. It is a Class II device, regulated under 21 CFR 866.5100 and reviewed by the Immunology panel. FDA has cleared 112 510(k) submissions under LJM, from 48 different applicants. The average 510(k) review took 99 days (median 82). FDA has posted 2 recalls for LJM devices.
Classification
| Field | Value |
|---|---|
| Device name | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls |
| 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 LJM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 90 |
Compare with all 510(k) review times · Search every LJM clearance
Top LJM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Elias U.S.A., Inc. | 16 | 1997-03-06 |
| Theratest Laboratories, Inc. | 6 | 2004-03-11 |
| Zeus Scientific, Inc. | 6 | 2000-05-22 |
| American Laboratory Products Co., Ltd. | 6 | 1996-11-18 |
| Biohytech International, Inc. | 6 | 1987-03-24 |
43 more applicants have LJM clearances. See the full list in Caduvo.
Most recent LJM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K182353 | Phadia AB | EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay | 2018-11-27 | 90 |
| K151559 | Immco Diagnostics, Inc. | ImmuLisa Enhanced Centromere Antibody ELISA | 2016-03-11 | 275 |
| K140493 | Phadia GmbH | ELIA SCL-70S IMMUNOASSAY | 2014-10-30 | 245 |
| K123880 | Inova Diagnostics, Inc. | QUANTA FLASH CENTROMERE | 2014-02-07 | 417 |
| K131330 | Gold Standard Diagnostics | GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT | 2014-01-28 | 265 |
Recalls for LJM devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-08-27.
Frequently asked questions
What is FDA product code LJM?
LJM is the FDA product code for antinuclear antibody (enzyme-labeled), antigen, controls. It is a Class II device, regulated under 21 CFR 866.5100 and reviewed by the Immunology panel.
What device class is LJM?
Class II, regulation 21 CFR 866.5100. Typical premarket route: 510(k).
How long does a 510(k) take for product code LJM?
Across 112 cleared submissions the average was 99 days from receipt to decision (median 82).
Which companies have the most LJM clearances?
Elias U.S.A., Inc. (16); Theratest Laboratories, Inc. (6); Zeus Scientific, Inc. (6); American Laboratory Products Co., Ltd. (6); Biohytech International, Inc. (6).
Have LJM devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2008-08-27.
Next steps
- Run an FDA pathway report with predicate devices for product code LJM
- Run a recall and safety report across every LJM manufacturer
- Watch product code LJM 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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