FDA product code LCQ: Fluorescent Immunoassay Gentamicin
LCQ is the FDA product code for fluorescent immunoassay gentamicin. It is a Class II device, regulated under 21 CFR 862.3450 and reviewed by the Clinical Toxicology panel. FDA has cleared 19 510(k) submissions under LCQ, from 17 different applicants. The average 510(k) review took 48 days (median 39). FDA has posted 3 recalls for LCQ devices.
Classification
| Field | Value |
|---|---|
| Device name | Fluorescent Immunoassay Gentamicin |
| Device class | Class II |
| Regulation | 21 CFR 862.3450 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LCQ clearance
Top LCQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Roche Diagnostic Systems, Inc. | 2 | 1995-03-09 |
| Abbott Laboratories | 2 | 1990-10-29 |
| Bio-Rad | 1 | 1997-08-06 |
| Oxis Intl., Inc. | 1 | 1996-02-09 |
| Sigma Diagnostics, Inc. | 1 | 1994-11-17 |
12 more applicants have LCQ clearances. See the full list in Caduvo.
Most recent LCQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K972609 | Bio-Rad | VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM | 1997-08-06 | 26 |
| K955569 | Oxis Intl., Inc. | INNOFLUOR GENTAMICIN ASSAY SYSTEM | 1996-02-09 | 65 |
| K945523 | Roche Diagnostic Systems, Inc. | COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS | 1995-03-09 | 119 |
| K943550 | Sigma Diagnostics, Inc. | GENTAMICIN FPIA REAGENT SET AND CALIBRATORS | 1994-11-17 | 119 |
| K905721 | Pb Diagnostic Systems, Inc. | OPUS GENTAMICIN | 1991-02-21 | 62 |
Recalls for LCQ devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-11-11.
Frequently asked questions
What is FDA product code LCQ?
LCQ is the FDA product code for fluorescent immunoassay gentamicin. It is a Class II device, regulated under 21 CFR 862.3450 and reviewed by the Clinical Toxicology panel.
What device class is LCQ?
Class II, regulation 21 CFR 862.3450. Typical premarket route: 510(k).
How long does a 510(k) take for product code LCQ?
Across 19 cleared submissions the average was 48 days from receipt to decision (median 39).
Which companies have the most LCQ clearances?
Roche Diagnostic Systems, Inc. (2); Abbott Laboratories (2); Bio-Rad (1); Oxis Intl., Inc. (1); Sigma Diagnostics, Inc. (1).
Have LCQ devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2015-11-11.
Next steps
- Run an FDA pathway report with predicate devices for product code LCQ
- Run a recall and safety report across every LCQ manufacturer
- Watch product code LCQ 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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