Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NQX — Predicate Candidate Screening
24 FDA 510(k) clearances under this product code; the 50 most recent screened below.
80 daysmedian FDA review time
242 days90th percentile
24clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243625 | Xpert MRSA/SA SSTI | Cepheid® | 2024-12-18 | 23 | 0 |
| K243070 | Xpert® SA Nasal Complete | Cepheid® | 2024-10-25 | 28 | 1 |
| K191742 | ARIES MRSA Assay | Luminex Corporation | 2019-09-25 | 86 | 0 |
| K190771 | Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert | Cepheid | 2019-04-25 | 30 | 0 |
| K162444 | Xpert MRSA NxG | Cepheid | 2016-11-23 | 84 | 0 |
| K142721 | cobas MRSA/SA Test | Roche Molecular Systems, Inc. | 2014-12-17 | 85 | 0 |
| K133605 | BD MAX MRSA XT, BD MAX INSTRUMENT | Geneohm Sciences Canada, Inc. | 2013-12-20 | 25 | 0 |
| K132822 | BD MAX STAPHSR ASSAY, INSTRUMENT | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2013-11-26 | 78 | 0 |
| K132468 | MRSA/SA ELITE MGB, ELITE MGB SOFTWARE | Elitechgroup Epoch Biosciences | 2013-10-17 | 71 | 0 |
| K130894 | XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX- | Cepheid | 2013-06-20 | 80 | 0 |
| K120138 | BD MAX MRSA ASSAY, BD MAX INSTRUMENT | Bd Diagnostics (Geneohm Sciences Canada, Inc) | 2012-07-05 | 170 | 3 |
| K112937 | MRSA/SA ELITE MGB | Elitech | 2012-06-01 | 242 | 0 |
| K112424 | VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC- | Nanosphere, Inc. | 2011-12-16 | 115 | 0 |
| K102740 | NUCLISENS EASYQ MRSA; NUCLISENS EASYQ ANALYZER; NUCLISENS EA | bioMerieux, Inc. | 2011-05-20 | 240 | 0 |
| K101879 | XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10 | Cepheid | 2010-07-28 | 22 | 1 |
| K091409 | LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER | Roche Molecular Systems, Inc. | 2010-07-06 | 419 | 0 |
| K100822 | XPERT MRSA/SA NASAL ASSAY | Cepheid | 2010-06-01 | 70 | 1 |
| K093346 | BD GENEOHM MRSA ACP ASSAY | Bd Diagnostics (Geneohm Sciences, Inc.) | 2009-12-15 | 50 | 2 |
| K082140 | XPERT MRSA/SA BLOOD CULTURE ASSAY | Cepheid | 2008-09-29 | 61 | 2 |
| K080837 | XPERT MRSA/SA SSTI ASSAY | Cepheid | 2008-09-24 | 183 | 0 |
| K071026 | BD GENEOHM STAPHSR ASSAY | Bd Diagnostics (Geneohm Sciences Canada, Inc) | 2007-12-20 | 253 | 0 |
| K070462 | XPERT MRSA | Cepheid | 2007-04-17 | 60 | 0 |
| K042357 | IDI-MRSA ASSAY | Infectio Diagnostic (I.D.I.), Inc. | 2004-10-22 | 52 | 3 |
| K033415 | IDI-MRSA | Infectio Diagnostic (I.D.I.), Inc. | 2004-03-18 | 143 | 1 |
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