Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OZN · Predicate Candidate Screening
17 FDA 510(k) clearances under this product code; the 50 most recent screened below.
87 daysmedian FDA review time
212 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243730 | Xpert C. difficile/Epi | Cepheid® | 2025-02-28 | 87 | 0 |
| K232092 | Great Basin Toxigenic C. difficile Direct Test (CDF2) | Vela Operations USA | 2023-11-14 | 124 | 0 |
| K212427 | cobas Cdiff nucleic acid test for use on the cobas Liat Syst | Roche Molecular Systems, Inc. | 2021-10-20 | 77 | 0 |
| K210385 | cobas Cdiff nucleic acid test for use on the cobas Liat Syst | Roche Molecular Systems, Inc. | 2021-09-09 | 212 | 0 |
| K172569 | GenePOC CDiff | Genepoc, Inc. | 2017-11-22 | 89 | 1 |
| K171770 | cobas Cdiff Nucleic acid test for use on the cobas Liat Syst | Roche Molecular Systems, Inc. | 2017-09-12 | 90 | 0 |
| K171441 | ARIES C. difficile Assay Complete Kit, ARIES C. difficile As | Luminex Corporation | 2017-07-21 | 66 | 1 |
| K170491 | Solana C. difficile Assay | Quidel Corporation | 2017-05-11 | 83 | 0 |
| K163085 | Simplexa C. difficile Direct; Simplexa C. difficile Positive | Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC | 2017-02-14 | 103 | 0 |
| K142422 | cobas Cdiff Test | Roche Molecular Systems, Inc. | 2015-05-20 | 265 | 0 |
| K133936 | ARTUS C. DIFFICILE QS-RGQ MDX KIT | QIAGEN GmbH | 2014-04-04 | 102 | 0 |
| K132726 | ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM | Primeradx | 2013-11-29 | 91 | 0 |
| K132235 | IMDX C.DIFFICILE FOR ABBOTT M2000 | Intelligent Medical Devices, Inc. | 2013-10-11 | 85 | 0 |
| K130470 | BD MAX CDIFF ASSAY, BD MAX INSTRUMENT | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2013-04-02 | 36 | 2 |
| K123998 | QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY | Quidel Corp. | 2013-03-08 | 72 | 0 |
| K123355 | AMPLIVUE C. DIFFICILE ASSAY | Quidel Corporation | 2012-12-13 | 43 | 0 |
| K123197 | VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF) | Nanosphere, Inc. | 2012-12-05 | 55 | 3 |
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