FDA product code LGR: Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)
LGR is the FDA product code for fluorescence polarization immunoassay, diphenylhydantoin (total). It is a Class II device, regulated under 21 CFR 862.3350 and reviewed by the Clinical Toxicology panel. FDA has cleared 15 510(k) submissions under LGR, from 11 different applicants. The average 510(k) review took 72 days (median 58).
Classification
| Field | Value |
|---|---|
| Device name | Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total) |
| Device class | Class II |
| Regulation | 21 CFR 862.3350 |
| 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 LGR clearance
Top LGR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abbott Laboratories | 3 | 1995-09-25 |
| Roche Diagnostic Systems, Inc. | 2 | 1994-03-11 |
| Innotron of Oregon, Inc. | 2 | 1989-10-31 |
| Ciba Corning Diagnostics Corp. | 1 | 1996-03-11 |
| Oxis Intl., Inc. | 1 | 1996-01-24 |
6 more applicants have LGR clearances. See the full list in Caduvo.
Most recent LGR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K955873 | Ciba Corning Diagnostics Corp. | ACS PHENYTOIN ASSAY | 1996-03-11 | 76 |
| K955562 | Oxis Intl., Inc. | INNOFLUOR PHENYTOIN ASSAY SYSTEM | 1996-01-24 | 49 |
| K953840 | Abbott Laboratories | AXSYM PHENYTOIN II | 1995-09-25 | 40 |
| K946328 | Abbott Laboratories | TDX(R)/TDXFLX(R) PHENYTOIN II | 1995-03-28 | 89 |
| K943313 | Sigma Diagnostics, Inc. | PHENYTOIN FPIA REAGENT SET AND CALIBRATORS | 1994-10-27 | 108 |
Recalls for LGR devices
openFDA lists no recalls for product code LGR.
Frequently asked questions
What is FDA product code LGR?
LGR is the FDA product code for fluorescence polarization immunoassay, diphenylhydantoin (total). It is a Class II device, regulated under 21 CFR 862.3350 and reviewed by the Clinical Toxicology panel.
What device class is LGR?
Class II, regulation 21 CFR 862.3350. Typical premarket route: 510(k).
How long does a 510(k) take for product code LGR?
Across 15 cleared submissions the average was 72 days from receipt to decision (median 58).
Which companies have the most LGR clearances?
Abbott Laboratories (3); Roche Diagnostic Systems, Inc. (2); Innotron of Oregon, Inc. (2); Ciba Corning Diagnostics Corp. (1); Oxis Intl., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LGR
- Run a recall and safety report across every LGR manufacturer
- Watch product code LGR 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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