FDA product code LLA: Direct Agglutination Test, Toxoplasma Gondii
LLA is the FDA product code for direct agglutination test, toxoplasma gondii. It is a Class II device, regulated under 21 CFR 866.3780 and reviewed by the Microbiology panel. FDA has cleared 4 510(k) submissions under LLA, from 3 different applicants. The average 510(k) review took 216 days (median 128).
Classification
| Field | Value |
|---|---|
| Device name | Direct Agglutination Test, Toxoplasma Gondii |
| Device class | Class II |
| Regulation | 21 CFR 866.3780 |
| 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 LLA clearance
Top LLA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 2 | 1985-05-20 |
| Biokit USA, Inc. | 1 | 1993-01-11 |
| Ampcor, Inc. | 1 | 1989-06-09 |
Most recent LLA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K913467 | Biokit USA, Inc. | TOXOGEN | 1993-01-11 | 525 |
| K890048 | Ampcor, Inc. | QUIK-DOT TOXOPLASMOSIS | 1989-06-09 | 154 |
| K850768 | Bd Becton Dickinson Vacutainer Systems Preanalytic | TOXOSCAN CARD TEST KIT | 1985-05-20 | 84 |
| K831930 | Bd Becton Dickinson Vacutainer Systems Preanalytic | TOXO-SCREEN DA TEST | 1983-09-26 | 103 |
Recalls for LLA devices
openFDA lists no recalls for product code LLA.
Frequently asked questions
What is FDA product code LLA?
LLA is the FDA product code for direct agglutination test, toxoplasma gondii. It is a Class II device, regulated under 21 CFR 866.3780 and reviewed by the Microbiology panel.
What device class is LLA?
Class II, regulation 21 CFR 866.3780. Typical premarket route: 510(k).
How long does a 510(k) take for product code LLA?
Across 4 cleared submissions the average was 216 days from receipt to decision (median 128).
Which companies have the most LLA clearances?
Bd Becton Dickinson Vacutainer Systems Preanalytic (2); Biokit USA, Inc. (1); Ampcor, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LLA
- Run a recall and safety report across every LLA manufacturer
- Watch product code LLA 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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