FDA product code LGS: Fluorescence Polarization Immunoassay, Theophylline
LGS is the FDA product code for fluorescence polarization immunoassay, theophylline. It is a Class II device, regulated under 21 CFR 862.3880 and reviewed by the Clinical Toxicology panel. FDA has cleared 13 510(k) submissions under LGS, from 10 different applicants. The average 510(k) review took 65 days (median 59).
Classification
| Field | Value |
|---|---|
| Device name | Fluorescence Polarization Immunoassay, Theophylline |
| Device class | Class II |
| Regulation | 21 CFR 862.3880 |
| 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 LGS clearance
Top LGS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abbott Laboratories | 3 | 1995-08-24 |
| Roche Diagnostic Systems, Inc. | 2 | 1987-05-28 |
| Biokit, S.A. | 1 | 2007-06-08 |
| Oxis Intl., Inc. | 1 | 1996-01-24 |
| Ciba Corning Diagnostics Corp. | 1 | 1995-06-20 |
5 more applicants have LGS clearances. See the full list in Caduvo.
Most recent LGS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K070810 | Biokit, S.A. | ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F) | 2007-06-08 | 74 |
| K955567 | Oxis Intl., Inc. | INNOFLUOR THEOPHYLLINE ASSAY SYSTEM | 1996-01-24 | 49 |
| K953016 | Abbott Laboratories | AXSYM THEOPHYLLINE II | 1995-08-24 | 56 |
| K951169 | Ciba Corning Diagnostics Corp. | CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY | 1995-06-20 | 97 |
| K942991 | Seradyn, Inc. | QMS THEOPHYLLINE CS | 1994-09-09 | 81 |
Recalls for LGS devices
openFDA lists no recalls for product code LGS.
Frequently asked questions
What is FDA product code LGS?
LGS is the FDA product code for fluorescence polarization immunoassay, theophylline. It is a Class II device, regulated under 21 CFR 862.3880 and reviewed by the Clinical Toxicology panel.
What device class is LGS?
Class II, regulation 21 CFR 862.3880. Typical premarket route: 510(k).
How long does a 510(k) take for product code LGS?
Across 13 cleared submissions the average was 65 days from receipt to decision (median 59).
Which companies have the most LGS clearances?
Abbott Laboratories (3); Roche Diagnostic Systems, Inc. (2); Biokit, S.A. (1); Oxis Intl., Inc. (1); Ciba Corning Diagnostics Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LGS
- Run a recall and safety report across every LGS manufacturer
- Watch product code LGS 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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