FDA product code LRM: Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
LRM is the FDA product code for anti-dna antibody (enzyme-labeled), antigen, control. It is a Class II device, regulated under 21 CFR 866.5100 and reviewed by the Immunology panel. FDA has cleared 29 510(k) submissions under LRM, from 23 different applicants. The average 510(k) review took 112 days (median 77). FDA has posted 3 recalls for LRM devices.
Classification
| Field | Value |
|---|---|
| Device name | Anti-Dna Antibody (Enzyme-Labeled), 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 |
Compare with all 510(k) review times · Search every LRM clearance
Top LRM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diamedix Corp. | 3 | 2000-02-18 |
| The Binding Site, Ltd. | 2 | 2006-11-21 |
| Helix Diagnostics, Inc. | 2 | 2000-09-11 |
| Hycor Biomedical, Inc. | 2 | 1997-03-07 |
| Elias U.S.A., Inc. | 2 | 1995-04-17 |
18 more applicants have LRM clearances. See the full list in Caduvo.
Most recent LRM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K101319 | Immco Diagnostics, Inc. | IMMULISA DSDNA ANTIBODY ELISA | 2010-12-09 | 212 |
| K083381 | Euroimmun Us, Inc. | EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG) | 2009-04-15 | 152 |
| K062183 | The Binding Site, Ltd. | FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT | 2006-11-21 | 113 |
| K040811 | Pharmacia Deutschland GmbH | VARELISA SSDNA ANTIBODIES, MODEL 14896 | 2004-05-13 | 45 |
| K001900 | Helix Diagnostics, Inc. | ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST | 2000-09-11 | 81 |
Recalls for LRM devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-03-02.
Frequently asked questions
What is FDA product code LRM?
LRM is the FDA product code for anti-dna antibody (enzyme-labeled), antigen, control. It is a Class II device, regulated under 21 CFR 866.5100 and reviewed by the Immunology panel.
What device class is LRM?
Class II, regulation 21 CFR 866.5100. Typical premarket route: 510(k).
How long does a 510(k) take for product code LRM?
Across 29 cleared submissions the average was 112 days from receipt to decision (median 77).
Which companies have the most LRM clearances?
Diamedix Corp. (3); The Binding Site, Ltd. (2); Helix Diagnostics, Inc. (2); Hycor Biomedical, Inc. (2); Elias U.S.A., Inc. (2).
Have LRM devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2010-03-02.
Next steps
- Run an FDA pathway report with predicate devices for product code LRM
- Run a recall and safety report across every LRM manufacturer
- Watch product code LRM 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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