FDA product code LQL: Gram Positive Identification Panel
LQL is the FDA product code for gram positive identification panel. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel. FDA has cleared 11 510(k) submissions under LQL, from 10 different applicants. The average 510(k) review took 187 days (median 183). FDA has posted 7 recalls for LQL devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Gram Positive Identification Panel |
| Device class | Class I |
| Regulation | 21 CFR 866.2660 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LQL clearance
Top LQL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biomerieux Vitek, Inc. | 2 | 1996-03-12 |
| Accumed Intl., Inc. | 1 | 1998-01-22 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1997-02-04 |
| Becton Dickinson Microbiology Systems | 1 | 1997-02-04 |
| Vitek Systems, Inc. | 1 | 1991-07-26 |
5 more applicants have LQL clearances. See the full list in Caduvo.
Most recent LQL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K972576 | Accumed Intl., Inc. | GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90 | 1998-01-22 | 196 |
| K961968 | Bd Becton Dickinson Vacutainer Systems Preanalytic | BBLCRYSTAL GRAM-POSITIVE ID SYSTEM | 1997-02-04 | 260 |
| K961730 | Becton Dickinson Microbiology Systems | RAPID GRAM-POSITIVE ID SYSTEM | 1997-02-04 | 277 |
| K952095 | Biomerieux Vitek, Inc. | VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI) | 1996-03-12 | 313 |
| K925916 | Biomerieux Vitek, Inc. | VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARD | 1993-03-23 | 120 |
Recalls for LQL devices
7 product recalls in 6 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2026-03-03.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2018 | 1 |
| 2022 | 2 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code LQL?
LQL is the FDA product code for gram positive identification panel. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel.
What device class is LQL?
Class I, regulation 21 CFR 866.2660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LQL?
Across 11 cleared submissions the average was 187 days from receipt to decision (median 183).
Which companies have the most LQL clearances?
Biomerieux Vitek, Inc. (2); Accumed Intl., Inc. (1); Bd Becton Dickinson Vacutainer Systems Preanalytic (1); Becton Dickinson Microbiology Systems (1); Vitek Systems, Inc. (1).
Have LQL devices been recalled?
Yes: 7 product recalls across 6 recall events; the most recent began 2026-03-03.
Next steps
- Run an FDA pathway report with predicate devices for product code LQL
- Run a recall and safety report across every LQL manufacturer
- Watch product code LQL 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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