FDA product code KXT: Enzyme Immunoassay, Digoxin
KXT is the FDA product code for enzyme immunoassay, digoxin. It is a Class II device, regulated under 21 CFR 862.3320 and reviewed by the Clinical Toxicology panel. FDA has cleared 85 510(k) submissions under KXT, from 46 different applicants. The average 510(k) review took 86 days (median 64). FDA has posted 7 recalls for KXT devices.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Immunoassay, Digoxin |
| Device class | Class II |
| Regulation | 21 CFR 862.3320 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for KXT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 588 |
Compare with all 510(k) review times · Search every KXT clearance
Top KXT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 10 | 1995-06-01 |
| Microgenics Corp. | 9 | 1994-06-13 |
| Abbott Laboratories | 5 | 2006-06-02 |
| E.I. Dupont DE Nemours & Co., Inc. | 5 | 1995-06-01 |
| Boehringer Mannheim Corp. | 4 | 1997-10-10 |
41 more applicants have KXT clearances. See the full list in Caduvo.
Most recent KXT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K193397 | Siemens Healthcare Diagnostics, Inc. | ADVIA Centaur® Digoxin assay | 2021-07-16 | 588 |
| K153301 | Roche Diagnostics | Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II | 2016-04-08 | 147 |
| K102346 | Randox Laboratories, Ltd. | RANDOX DIGOXIN ASSAY | 2011-10-14 | 421 |
| K093441 | Siemens Healthcare Diagnostics | DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435 | 2010-04-07 | 153 |
| K082953 | Biokit, S.A. | ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01 | 2008-12-22 | 80 |
Recalls for KXT devices
7 product recalls in 7 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-03-21.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code KXT?
KXT is the FDA product code for enzyme immunoassay, digoxin. It is a Class II device, regulated under 21 CFR 862.3320 and reviewed by the Clinical Toxicology panel.
What device class is KXT?
Class II, regulation 21 CFR 862.3320. Typical premarket route: 510(k).
How long does a 510(k) take for product code KXT?
Across 85 cleared submissions the average was 86 days from receipt to decision (median 64).
Which companies have the most KXT clearances?
Syva Co. (10); Microgenics Corp. (9); Abbott Laboratories (5); E.I. Dupont DE Nemours & Co., Inc. (5); Boehringer Mannheim Corp. (4).
Have KXT devices been recalled?
Yes: 7 product recalls across 7 recall events; the most recent began 2017-03-21.
Next steps
- Run an FDA pathway report with predicate devices for product code KXT
- Run a recall and safety report across every KXT manufacturer
- Watch product code KXT 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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