FDA product code KLS: Enzyme Immunoassay, Theophylline
KLS is the FDA product code for enzyme immunoassay, theophylline. It is a Class II device, regulated under 21 CFR 862.3880 and reviewed by the Clinical Toxicology panel. FDA has cleared 71 510(k) submissions under KLS, from 45 different applicants. The average 510(k) review took 69 days (median 48). FDA has posted 8 recalls for KLS devices.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme 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 KLS clearance
Top KLS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 11 | 2000-01-27 |
| Abbott Laboratories | 7 | 1994-06-21 |
| E.I. Dupont DE Nemours & Co., Inc. | 3 | 1986-09-25 |
| Diagnostic Products Corp. | 2 | 1995-11-13 |
| Instrumentation Laboratory CO | 2 | 1995-01-18 |
40 more applicants have KLS clearances. See the full list in Caduvo.
Most recent KLS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K042520 | Ortho-Clinical Diagnostics, Inc. | VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III | 2004-11-30 | 75 |
| K042407 | Dade Behring, Inc. | EMIT CAFFEINE ASSAY | 2004-10-28 | 55 |
| K020740 | Roche Diagnostics Corp. | ROCHE ONLINE THEOPHYLLINE | 2002-04-16 | 41 |
| K011771 | Randox Laboratories, Ltd. | RANDOX THEOPHYLLINE | 2002-01-17 | 225 |
| K013272 | Bayer Corp. | ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY | 2001-10-25 | 24 |
Recalls for KLS devices
8 product recalls in 6 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-11-27.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code KLS?
KLS is the FDA product code for enzyme 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 KLS?
Class II, regulation 21 CFR 862.3880. Typical premarket route: 510(k).
How long does a 510(k) take for product code KLS?
Across 71 cleared submissions the average was 69 days from receipt to decision (median 48).
Which companies have the most KLS clearances?
Syva Co. (11); Abbott Laboratories (7); E.I. Dupont DE Nemours & Co., Inc. (3); Diagnostic Products Corp. (2); Instrumentation Laboratory CO (2).
Have KLS devices been recalled?
Yes: 8 product recalls across 6 recall events; the most recent began 2017-11-27.
Next steps
- Run an FDA pathway report with predicate devices for product code KLS
- Run a recall and safety report across every KLS manufacturer
- Watch product code KLS 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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