FDA product code KTL: Anti-Dna Indirect Immunofluorescent Solid Phase
KTL is the FDA product code for anti-dna indirect immunofluorescent solid phase. It is a Class II device, regulated under 21 CFR 866.5100 and reviewed by the Immunology panel. FDA has cleared 19 510(k) submissions under KTL, 2 in the last five years, from 17 different applicants. The average 510(k) review took 160 days (median 51).
Classification
| Field | Value |
|---|---|
| Device name | Anti-Dna Indirect Immunofluorescent Solid Phase |
| Device class | Class II |
| Regulation | 21 CFR 866.5100 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for KTL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 268 |
| 2020 | 1 | 423 |
| 2023 | 2 | 494 |
Compare with all 510(k) review times · Search every KTL clearance
Top KTL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Euroimmun Us, Inc. | 2 | 2018-04-20 |
| Intl. Diagnostic Technology | 2 | 1984-01-20 |
| Zeus Scientific | 1 | 2023-08-31 |
| Immuno Concepts, N.A. , Ltd. | 1 | 2023-05-26 |
| Inova Diagnostics, Inc. | 1 | 2020-12-11 |
12 more applicants have KTL clearances. See the full list in Caduvo.
Most recent KTL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K231616 | Zeus Scientific | ZEUS IFA(TM) nDNA Test System, ZEUS dIFine | 2023-08-31 | 90 |
| K203599 | Immuno Concepts, N.A. , Ltd. | Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System | 2023-05-26 | 898 |
| K192916 | Inova Diagnostics, Inc. | NOVA Lite DAPI dsDNA Crithidia luciliae Kit | 2020-12-11 | 423 |
| K172244 | Euroimmun Us, Inc. | EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern | 2018-04-20 | 268 |
| K172252 | Euroimmun Us, Inc. | EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern | 2018-04-20 | 268 |
Recalls for KTL devices
openFDA lists no recalls for product code KTL.
Frequently asked questions
What is FDA product code KTL?
KTL is the FDA product code for anti-dna indirect immunofluorescent solid phase. It is a Class II device, regulated under 21 CFR 866.5100 and reviewed by the Immunology panel.
What device class is KTL?
Class II, regulation 21 CFR 866.5100. Typical premarket route: 510(k).
How long does a 510(k) take for product code KTL?
Across 19 cleared submissions the average was 160 days from receipt to decision (median 51).
Which companies have the most KTL clearances?
Euroimmun Us, Inc. (2); Intl. Diagnostic Technology (2); Zeus Scientific (1); Immuno Concepts, N.A. , Ltd. (1); Inova Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KTL
- Run a recall and safety report across every KTL manufacturer
- Watch product code KTL 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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