Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NTI — Predicate Candidate Screening
11 FDA 510(k) clearances under this product code; the 50 most recent screened below.
132 daysmedian FDA review time
296 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220026 | Genomadix Cube CYP2C19 System | Genomadix, Inc. | 2023-03-21 | 440 | 0 |
| K170492 | xTAG CYP2D6 Kit v3 | Luminex Molecular Diagnostics, Inc. | 2017-08-11 | 175 | 0 |
| K131565 | XTAG CYP2C19 KIT V3 | Luminex Molecular Diagnostics, Inc. | 2013-09-11 | 104 | 0 |
| K123891 | SPARTAN RX CYP2C19 TEST SYSTEM | Spartan Bioscience, Inc. | 2013-08-12 | 237 | 0 |
| K130189 | XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE) | Luminex Molecular Diagnostics, Inc. | 2013-05-21 | 116 | 0 |
| K120466 | VERIGENE CYP2C19 NUCLEIC ACID TES (2C19) | Nanosphere, Inc. | 2012-11-06 | 265 | 1 |
| K101683 | INFINITI CYP2C19 ASSAY | Autogenomics, Incorporated | 2010-10-25 | 132 | 0 |
| K093420 | XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP | Luminex Molecular Diagnostics, Inc. | 2010-08-26 | 296 | 1 |
| K051824 | INVADER UGT1A1 MOLECULAR ASSAY | Third Wave Technologies, Inc. | 2005-08-18 | 44 | 0 |
| K043576 | ROCHE AMPLICHIP CYP450 TEST | Roche Molecular Systems, Inc. | 2005-01-10 | 14 | 1 |
| DEN040011 | AMPLICHIP CYP450 TEST, MODEL 04381866190 | Roche Molecular Systems, Inc. | 2004-12-23 | 3 | 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