FDA product code LSL: Dna-Reagents, Neisseria
LSL is the FDA product code for dna-reagents, neisseria. It is a Class II device, regulated under 21 CFR 866.3390 and reviewed by the Microbiology panel. FDA has cleared 45 510(k) submissions under LSL, 1 in the last five years, from 15 different applicants. The average 510(k) review took 215 days (median 133); 263 days on average over the last three years. FDA has posted 7 recalls for LSL devices.
Classification
| Field | Value |
|---|---|
| Device name | Dna-Reagents, Neisseria |
| Device class | Class II |
| Regulation | 21 CFR 866.3390 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for LSL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 87 |
| 2018 | 3 | 89 |
| 2024 | 1 | 263 |
Compare with all 510(k) review times · Search every LSL clearance
Top LSL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gen-Probe, Inc. | 15 | 2012-05-03 |
| Becton, Dickinson & CO | 8 | 2014-05-20 |
| Roche Molecular Systems, Inc. | 6 | 2018-03-21 |
| Digene Corp. | 3 | 2001-09-24 |
| Hologic, Inc. | 2 | 2024-01-26 |
10 more applicants have LSL clearances. See the full list in Caduvo.
Most recent LSL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K231329 | Hologic, Inc. | Aptima Neisseria gonorrhoeae Assay | 2024-01-26 | 263 |
| K180681 | Hologic, Inc. | Aptima Combo 2 Assay (Panther System) | 2018-06-13 | 90 |
| K173887 | Roche Molecular Systems, Inc. | cobas CT/NG for use on cobas 6800/8800 systems | 2018-03-21 | 90 |
| K173840 | Cepheid | Xpert CT/NG | 2018-03-16 | 88 |
| K163184 | Roche Molecular Systems, Inc. | cobas® CT/NG v2.0 Test | 2017-02-09 | 87 |
Recalls for LSL devices
7 product recalls in 5 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-10-09.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code LSL?
LSL is the FDA product code for dna-reagents, neisseria. It is a Class II device, regulated under 21 CFR 866.3390 and reviewed by the Microbiology panel.
What device class is LSL?
Class II, regulation 21 CFR 866.3390. Typical premarket route: 510(k).
How long does a 510(k) take for product code LSL?
Across 45 cleared submissions the average was 215 days from receipt to decision (median 133).
Which companies have the most LSL clearances?
Gen-Probe, Inc. (15); Becton, Dickinson & CO (8); Roche Molecular Systems, Inc. (6); Digene Corp. (3); Hologic, Inc. (2).
Have LSL devices been recalled?
Yes: 7 product recalls across 5 recall events; the most recent began 2017-10-09.
Next steps
- Run an FDA pathway report with predicate devices for product code LSL
- Run a recall and safety report across every LSL manufacturer
- Watch product code LSL 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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