FDA product code LER: Fluorescent Immunoassay, Theophylline
LER is the FDA product code for fluorescent immunoassay, theophylline. It is a Class II device, regulated under 21 CFR 862.3880 and reviewed by the Clinical Toxicology panel. FDA has cleared 15 510(k) submissions under LER, from 13 different applicants. The average 510(k) review took 45 days (median 41). FDA has posted 1 recall for LER devices.
Classification
| Field | Value |
|---|---|
| Device name | Fluorescent 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 LER clearance
Top LER applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Miles Laboratories, Inc. | 3 | 1983-06-30 |
| Sigma Diagnostics, Inc. | 1 | 1994-07-13 |
| Microgenics Corp. | 1 | 1990-12-26 |
| Unipath , Ltd. | 1 | 1988-11-10 |
| Sclavo, Inc. | 1 | 1986-12-22 |
8 more applicants have LER clearances. See the full list in Caduvo.
Most recent LER clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K942192 | Sigma Diagnostics, Inc. | THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORS | 1994-07-13 | 70 |
| K905521 | Microgenics Corp. | CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATION | 1990-12-26 | 19 |
| K882570 | Unipath , Ltd. | TURBOX THEOPHYLLINE ASSAY | 1988-11-10 | 141 |
| K864409 | Sclavo, Inc. | IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS | 1986-12-22 | 42 |
| K863475 | 3M Company | THEOFAST(TM) TEST PACKAGE | 1986-11-05 | 57 |
Recalls for LER devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2007-04-11.
Frequently asked questions
What is FDA product code LER?
LER is the FDA product code for fluorescent 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 LER?
Class II, regulation 21 CFR 862.3880. Typical premarket route: 510(k).
How long does a 510(k) take for product code LER?
Across 15 cleared submissions the average was 45 days from receipt to decision (median 41).
Which companies have the most LER clearances?
Miles Laboratories, Inc. (3); Sigma Diagnostics, Inc. (1); Microgenics Corp. (1); Unipath , Ltd. (1); Sclavo, Inc. (1).
Have LER devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2007-04-11.
Next steps
- Run an FDA pathway report with predicate devices for product code LER
- Run a recall and safety report across every LER manufacturer
- Watch product code LER 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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