FDA product code KLI: Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
KLI is the FDA product code for enzyme immunoassay, non-radiolabeled, total thyroxine. It is a Class II device, regulated under 21 CFR 862.1700 and reviewed by the Clinical Chemistry panel. FDA has cleared 86 510(k) submissions under KLI, from 55 different applicants. The average 510(k) review took 80 days (median 58). FDA has posted 12 recalls for KLI devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine |
| Device class | Class II |
| Regulation | 21 CFR 862.1700 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KLI clearance
Top KLI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 14 | 1992-09-18 |
| Microgenics Corp. | 6 | 1994-10-20 |
| Abbott Laboratories | 4 | 1998-11-25 |
| Technicon Instruments Corp. | 4 | 1991-09-25 |
| Monobind | 2 | 2003-08-22 |
50 more applicants have KLI clearances. See the full list in Caduvo.
Most recent KLI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K160495 | Ortho-Clinical Diagnostics, Inc. | VITROS® Automation Solutions | 2016-10-18 | 239 |
| K131515 | Alfa Wassermann | ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT | 2013-08-14 | 78 |
| K103484 | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | GSP NEONATAL THYROXINE (T4) | 2011-04-22 | 147 |
| K082638 | Siemens Healthcare Diagnostics, Inc. | ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL | 2009-02-26 | 169 |
| K030860 | Monobind | ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 | 2003-08-22 | 157 |
Recalls for KLI devices
12 product recalls in 12 recall events; 4 initiated in the last five years and 3 still open. Most recent: 2026-03-16.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
| 2020 | 1 |
| 2021 | 2 |
| 2024 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code KLI?
KLI is the FDA product code for enzyme immunoassay, non-radiolabeled, total thyroxine. It is a Class II device, regulated under 21 CFR 862.1700 and reviewed by the Clinical Chemistry panel.
What device class is KLI?
Class II, regulation 21 CFR 862.1700. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KLI?
Across 86 cleared submissions the average was 80 days from receipt to decision (median 58).
Which companies have the most KLI clearances?
Syva Co. (14); Microgenics Corp. (6); Abbott Laboratories (4); Technicon Instruments Corp. (4); Monobind (2).
Have KLI devices been recalled?
Yes: 12 product recalls across 12 recall events; the most recent began 2026-03-16.
Next steps
- Run an FDA pathway report with predicate devices for product code KLI
- Run a recall and safety report across every KLI manufacturer
- Watch product code KLI 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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