FDA product code LQM: Gram Negative Identification Panel
LQM is the FDA product code for gram negative identification panel. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel. FDA has cleared 7 510(k) submissions under LQM, from 7 different applicants. The average 510(k) review took 129 days (median 119). FDA has posted 2 recalls for LQM devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Gram Negative 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 LQM clearance
Top LQM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Roche Diagnostic Systems, Inc. | 1 | 1993-04-05 |
| Biomerieux Vitek, Inc. | 1 | 1993-03-23 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1991-10-28 |
| Vitek Systems, Inc. | 1 | 1991-06-24 |
| Radiometer America, Inc. | 1 | 1989-06-09 |
2 more applicants have LQM clearances. See the full list in Caduvo.
Most recent LQM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K923313 | Roche Diagnostic Systems, Inc. | ROCHE OXI/FERM II | 1993-04-05 | 272 |
| K925915 | Biomerieux Vitek, Inc. | VITEK RAPID CALL-GRAM NEGATIV IDENT CARD | 1993-03-23 | 120 |
| K912897 | Bd Becton Dickinson Vacutainer Systems Preanalytic | SCEPTOR IDENTIFICATION SYSTEM | 1991-10-28 | 119 |
| K911429 | Vitek Systems, Inc. | VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIED | 1991-06-24 | 90 |
| K890057 | Radiometer America, Inc. | SENSITITRE AUTO ID PLATE AP80 | 1989-06-09 | 154 |
Recalls for LQM devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-11-09.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code LQM?
LQM is the FDA product code for gram negative identification panel. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel.
What device class is LQM?
Class I, regulation 21 CFR 866.2660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LQM?
Across 7 cleared submissions the average was 129 days from receipt to decision (median 119).
Which companies have the most LQM clearances?
Roche Diagnostic Systems, Inc. (1); Biomerieux Vitek, Inc. (1); Bd Becton Dickinson Vacutainer Systems Preanalytic (1); Vitek Systems, Inc. (1); Radiometer America, Inc. (1).
Have LQM devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2022-11-09.
Next steps
- Run an FDA pathway report with predicate devices for product code LQM
- Run a recall and safety report across every LQM manufacturer
- Watch product code LQM 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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