Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NJR — Predicate Candidate Screening
18 FDA 510(k) clearances under this product code; the 50 most recent screened below.
133 daysmedian FDA review time
485 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K222638 | Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity | Cepheid | 2023-09-27 | 391 | 0 |
| K203429 | Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity Sys | Cepheid | 2022-05-09 | 535 | 0 |
| K182467 | Simplexa GBS Direct, Simplexa GBS Positive Control Pack | Diasorin Molecular, LLC | 2018-11-07 | 58 | 0 |
| K181156 | Panther Fusion GBS Assay | Diagenode | 2018-07-27 | 87 | 2 |
| K173725 | NeuMoDx GBS Assay | Neumodx Molecular, Inc. | 2018-06-26 | 203 | 0 |
| K173250 | Solana GBS Assay | Quidel Corporation | 2017-12-21 | 72 | 0 |
| K170557 | GenePOC GBS LB | Genepoc, Inc. | 2017-05-25 | 90 | 0 |
| K162772 | ARIES GBS Assay | Luminex Corporation | 2016-12-23 | 81 | 2 |
| K143312 | Portrait GBS Assay | Great Basin Corporation | 2015-04-21 | 154 | 0 |
| K133503 | AMPLIVUE GBS ASSAY | Quidel Corporation | 2013-12-20 | 36 | 0 |
| K121539 | XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX | Cepheid | 2012-11-02 | 162 | 0 |
| K121044 | ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM | Meridian Bioscience, Inc. | 2012-05-01 | 25 | 1 |
| K111860 | BD MAX GBS ASSAY, BD MAX INSTRUMENT | Becton, Dickinson & CO | 2012-02-16 | 231 | 7 |
| K112125 | ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT | Meridian Bioscience, Inc. | 2011-12-05 | 133 | 0 |
| K090191 | HANDYLAB GBS ASSAY, HANDYLAB JAGUAR INSTRUMENT, HANDYLAB DNA | Handylab, Inc. | 2010-05-27 | 485 | 0 |
| K062948 | SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7 | Cepheid | 2006-12-08 | 71 | 0 |
| K060540 | XPERT, GENEXPERT DX SYSTEM | Cepheid | 2006-07-25 | 146 | 1 |
| K022504 | IDI-STREP B ASSAY | Infectio Diagnostic, Inc. | 2002-11-18 | 112 | 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