FDA product code LFW: Fluorescence Polarization Immunoassay, Tobramycin
LFW is the FDA product code for fluorescence polarization immunoassay, tobramycin. It is a Class II device, regulated under 21 CFR 862.3900 and reviewed by the Clinical Toxicology panel. FDA has cleared 10 510(k) submissions under LFW, from 8 different applicants. The average 510(k) review took 70 days (median 66). FDA has posted 2 recalls for LFW devices.
Classification
| Field | Value |
|---|---|
| Device name | Fluorescence Polarization Immunoassay, Tobramycin |
| Device class | Class II |
| Regulation | 21 CFR 862.3900 |
| 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 LFW clearance
Top LFW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Roche Diagnostic Systems, Inc. | 2 | 1997-02-04 |
| Innotron of Oregon, Inc. | 2 | 1990-04-20 |
| Sigma Diagnostics, Inc. | 1 | 1994-11-10 |
| Abbott Laboratories | 1 | 1994-08-18 |
| Microgenics Corp. | 1 | 1991-07-26 |
3 more applicants have LFW clearances. See the full list in Caduvo.
Most recent LFW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K964670 | Roche Diagnostic Systems, Inc. | ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN | 1997-02-04 | 75 |
| K944371 | Sigma Diagnostics, Inc. | TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR | 1994-11-10 | 64 |
| K941614 | Abbott Laboratories | AXSYM TOBRAMYCIN | 1994-08-18 | 136 |
| K912143 | Microgenics Corp. | CEDIA(R) TOBRAMYCIN ASSAY | 1991-07-26 | 72 |
| K900707 | Innotron of Oregon, Inc. | MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR | 1990-04-20 | 67 |
Recalls for LFW devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-10-16.
Frequently asked questions
What is FDA product code LFW?
LFW is the FDA product code for fluorescence polarization immunoassay, tobramycin. It is a Class II device, regulated under 21 CFR 862.3900 and reviewed by the Clinical Toxicology panel.
What device class is LFW?
Class II, regulation 21 CFR 862.3900. Typical premarket route: 510(k).
How long does a 510(k) take for product code LFW?
Across 10 cleared submissions the average was 70 days from receipt to decision (median 66).
Which companies have the most LFW clearances?
Roche Diagnostic Systems, Inc. (2); Innotron of Oregon, Inc. (2); Sigma Diagnostics, Inc. (1); Abbott Laboratories (1); Microgenics Corp. (1).
Have LFW devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2013-10-16.
Next steps
- Run an FDA pathway report with predicate devices for product code LFW
- Run a recall and safety report across every LFW manufacturer
- Watch product code LFW 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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