FDA product code LGQ: Fluorescence Polarization Immunoassay, Phenobarbital
LGQ is the FDA product code for fluorescence polarization immunoassay, phenobarbital. It is a Class II device, regulated under 21 CFR 862.3660 and reviewed by the Clinical Toxicology panel. FDA has cleared 12 510(k) submissions under LGQ, from 8 different applicants. The average 510(k) review took 54 days (median 39). FDA has posted 2 recalls for LGQ devices.
Classification
| Field | Value |
|---|---|
| Device name | Fluorescence Polarization Immunoassay, Phenobarbital |
| Device class | Class II |
| Regulation | 21 CFR 862.3660 |
| 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 LGQ clearance
Top LGQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Roche Diagnostic Systems, Inc. | 3 | 1994-03-11 |
| Oxis Intl., Inc. | 2 | 1997-08-01 |
| Abbott Laboratories | 2 | 1994-06-21 |
| Innotron of Oregon, Inc. | 1 | 1990-04-12 |
| Colony Laboratories, Inc. | 1 | 1989-08-28 |
3 more applicants have LGQ clearances. See the full list in Caduvo.
Most recent LGQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K972331 | Oxis Intl., Inc. | INNOFLUOR GENTAMICIN ASSAY SYSTEM | 1997-08-01 | 39 |
| K972330 | Oxis Intl., Inc. | INNOFLUOR PHENOBARBITAL ASSAY SYSTEM | 1997-07-14 | 21 |
| K940596 | Abbott Laboratories | AXSYM PHENOBARBITAL | 1994-06-21 | 131 |
| K936130 | Roche Diagnostic Systems, Inc. | COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS | 1994-03-11 | 78 |
| K900704 | Innotron of Oregon, Inc. | MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRA | 1990-04-12 | 59 |
Recalls for LGQ devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2003-11-17.
Frequently asked questions
What is FDA product code LGQ?
LGQ is the FDA product code for fluorescence polarization immunoassay, phenobarbital. It is a Class II device, regulated under 21 CFR 862.3660 and reviewed by the Clinical Toxicology panel.
What device class is LGQ?
Class II, regulation 21 CFR 862.3660. Typical premarket route: 510(k).
How long does a 510(k) take for product code LGQ?
Across 12 cleared submissions the average was 54 days from receipt to decision (median 39).
Which companies have the most LGQ clearances?
Roche Diagnostic Systems, Inc. (3); Oxis Intl., Inc. (2); Abbott Laboratories (2); Innotron of Oregon, Inc. (1); Colony Laboratories, Inc. (1).
Have LGQ devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2003-11-17.
Next steps
- Run an FDA pathway report with predicate devices for product code LGQ
- Run a recall and safety report across every LGQ manufacturer
- Watch product code LGQ 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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