FDA product code LQN: Latex Agglutination Assay, Rubella
LQN is the FDA product code for latex agglutination assay, rubella. It is a Class II device, regulated under 21 CFR 866.3510 and reviewed by the Microbiology panel. FDA has cleared 13 510(k) submissions under LQN, from 7 different applicants. The average 510(k) review took 150 days (median 182).
Classification
| Field | Value |
|---|---|
| Device name | Latex Agglutination Assay, Rubella |
| Device class | Class II |
| Regulation | 21 CFR 866.3510 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LQN clearance
Top LQN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Orion Corp. | 4 | 1992-05-04 |
| Sienna Biotech, Inc. | 2 | 1997-04-24 |
| Biokit USA, Inc. | 2 | 1989-11-29 |
| Armkel, LLC | 2 | 1985-05-21 |
| Immunostics Inc., | 1 | 2003-07-16 |
2 more applicants have LQN clearances. See the full list in Caduvo.
Most recent LQN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K031490 | Immunostics Inc., | RUBELLACOL | 2003-07-16 | 65 |
| K970931 | Sienna Biotech, Inc. | COPALIS TORC TOTAL ANTIBODY ASSAY | 1997-04-24 | 48 |
| K961784 | Sienna Biotech, Inc. | COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS | 1996-10-31 | 182 |
| K954920 | Murex Diagnostics, Inc. | MUREX RUB-EX | 1996-08-21 | 300 |
| K952544 | Seradyn, Inc. | COLORSLIDER RUBELLA | 1996-01-17 | 229 |
Recalls for LQN devices
openFDA lists no recalls for product code LQN.
Frequently asked questions
What is FDA product code LQN?
LQN is the FDA product code for latex agglutination assay, rubella. It is a Class II device, regulated under 21 CFR 866.3510 and reviewed by the Microbiology panel.
What device class is LQN?
Class II, regulation 21 CFR 866.3510. Typical premarket route: 510(k).
How long does a 510(k) take for product code LQN?
Across 13 cleared submissions the average was 150 days from receipt to decision (median 182).
Which companies have the most LQN clearances?
Orion Corp. (4); Sienna Biotech, Inc. (2); Biokit USA, Inc. (2); Armkel, LLC (2); Immunostics Inc., (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LQN
- Run a recall and safety report across every LQN manufacturer
- Watch product code LQN 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.
All Microbiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times