Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KTL · Predicate Candidate Screening
19 FDA 510(k) clearances under this product code; the 50 most recent screened below.
51 daysmedian FDA review time
423 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231616 | ZEUS IFA(TM) nDNA Test System, ZEUS dIFine | Zeus Scientific | 2023-08-31 | 90 | 0 |
| K203599 | Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti | Immuno Concepts, N.A. , Ltd. | 2023-05-26 | 898 | 0 |
| K192916 | NOVA Lite DAPI dsDNA Crithidia luciliae Kit | Inova Diagnostics, Inc. | 2020-12-11 | 423 | 0 |
| K172252 | EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUR | Euroimmun Us, Inc. | 2018-04-20 | 268 | 0 |
| K172244 | EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern | Euroimmun Us, Inc. | 2018-04-20 | 268 | 0 |
| K011068 | RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L | Rhigene, Inc. | 2002-04-11 | 367 | 0 |
| K013432 | IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G | Immuno Concepts, Inc. | 2001-11-29 | 45 | 0 |
| K990916 | INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY | Stellar Bio Systems, Inc. | 1999-04-21 | 34 | 0 |
| K930987 | CRITHIDIA LUCILLIAE DS DNA KIT (DIAGNOSTIC USE) | The Binding Site, Ltd. | 1993-08-10 | 166 | 0 |
| K905386 | DISTAT ANTI-DSDNA KIT | Shield Diagnostics, Ltd. | 1990-12-13 | 13 | 0 |
| K864275 | ANTI-NDNA ANTIBODY TEST KIT | Cappel Diagnostics, Inc. | 1986-12-15 | 47 | 0 |
| K861978 | AUTOFLUOR V | Technia Diagnostics , Ltd. | 1986-06-10 | 20 | 0 |
| K842707 | ADP NDNA IFA TEST | Apple Diagnostic Products | 1984-08-21 | 40 | 0 |
| K834349 | ANTI-NATIVE DNA ANTIBODY | Sigma Chemical Co. | 1984-04-19 | 128 | 0 |
| K834140 | ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS | Intl. Diagnostic Technology | 1984-01-20 | 51 | 0 |
| K833984 | ANTINUCLEAR ANTIBODY IMMUNOLOGICAL | Intl. Diagnostic Technology | 1984-01-04 | 48 | 0 |
| K832031 | ANTI-N DNA ANTIBODY TEST KIT | Breit Laboratories, Inc. | 1983-08-11 | 49 | 0 |
| K830652 | ANTI N DNA-HCP | Immuno-Products Industries | 1983-03-24 | 17 | 0 |
| K791354 | CODE QAS 103 ANTI-DNA CONTROLS | Amersham Corp. | 1979-09-17 | 61 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda