510(k) · Cleared
ClearedIllumigene Group B Streptococcus ,External Control Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meridian Bioscience, Inc. · NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Cleared on Dec 5, 2011 as substantially equivalent to K062948 (Cepheid, 2006) after a 133-day review. Its family tree reaches back 4 generations to 1994. 4 later devices descend from it.
- Decided
- Dec 5, 2011
- Review
- 133 days
- Class
- Class I
- Product code
- NJR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K936112 (1994). 4 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK936112 Strep B OiaBiostar, Inc. · 1994
- 3 generations backK991828 Strep B OiaBiostar, Inc. · 1999
- 2 generations backK022504 Idi-Strep B AssayInfectio Diagnostic, Inc. · 2002
- 1 generation backK062948 Smart GBS and Smartcycle DX System and Software, Version 1.7BCepheid · 2006
- This deviceK112125 Illumigene Group B Streptococcus ,External Control KitMeridian Bioscience, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK133503 Amplivue GBS AssayQuidel Corporation · 2013
- Descendant · 2 generations on · 0 of its ownK173250 Solana GBS AssayQuidel Corporation · 2017
- Descendant · cites it directly · 0 of its ownK143312 Portrait GBS AssayGreat Basin Corporation · 2015
- Descendant · cites it directly · 0 of its ownK121044 Illumigene Group B Streptococcus Carrot Broth ClaimMeridian Bioscience, Inc. · 2012 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K133503Amplivue GBS AssayQuidel Corporation · 2013 · cites it directly1descendant
- K173250Solana GBS AssayQuidel Corporation · 2017 · 2 generations on0descendants
- K143312Portrait GBS AssayGreat Basin Corporation · 2015 · cites it directly0descendants
- K121044Illumigene Group B Streptococcus Carrot Broth ClaimMeridian Bioscience, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K936112 | Strep B Oia | Biostar, Inc. | 1994 | — |
| −3 | K991828 | Strep B Oia | Biostar, Inc. | 1999 | — |
| −2 | K022504 | Idi-Strep B Assay | Infectio Diagnostic, Inc. | 2002 | — |
| −1 | K062948 | Smart GBS and Smartcycle DX System and Software, Version 1.7B | Cepheid | 2006 | — |
| 0 (this device) | K112125 | Illumigene Group B Streptococcus ,External Control Kit | Meridian Bioscience, Inc. | 2011 | — |
| +1 | K133503 | Amplivue GBS Assay | Quidel Corporation | 2013 | — |
| +2 | K173250 | Solana GBS Assay | Quidel Corporation | 2017 | — |
| +1 | K143312 | Portrait GBS Assay | Great Basin Corporation | 2015 | — |
| +1 | K121044 | Illumigene Group B Streptococcus Carrot Broth Claim | Meridian Bioscience, Inc. | 2012 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NJR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NJR device
- #1 K222638 Xpert® Xpress GBS, GeneXpert® Dx System…score 7.0 · 4 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K062948 | Smart GBS and Smartcycle DX System and Software, Version 1.7BSummary page 1…Amplification Assay System, Group B Streptococcus Direct Specimen Test NJR, CFR Section 866.3740 Predicate device: K062948: CepheidO Smart CBS Model SCGBS-100N-50 Reference comparator: Culture enrichmen… | 2006 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 5.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K133503 (Quidel Corporation, 2013) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K062948.
How does its category compare?
All NJR devicesNJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · NJR
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NJR
87in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NJR
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NJR
14in 2024
MAUDE reports naming product code NJR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 1 | 0 |
| 2012 | 3 | 162 | 2 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 1 | — | 1 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 1 |
| 2018 | 3 | 87 | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 1 | — | 1 | 3 |
| 2023 | 1 | — | 0 | 8 |
| 2024 | 0 | — | 2 | 14 |
| 2025 | 0 | — | 1 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The illumigene Group BStreptococcus (GBS) assay, performed on the illumnipro-IO™, is aqualitative in vitro diagnostic for the detection of Streptococcus ogoloctioe in enriched cultures obtained from vaginal/rectal swab specimens from antepartdmn women. Enriched cultures are obtained by 18 -24 hour incubation of vaginal/rectal swab specimens in selective broth medium, either Lim Broth [Todd Hewitt Broth supplemented with colistin (10 pg/mL) and nalidixic…
Read the full statement (180 words)
The illumigene Group BStreptococcus (GBS) assay, performed on the illumnipro-IO™, is aqualitative in vitro diagnostic for the detection of Streptococcus ogoloctioe in enriched cultures obtained from vaginal/rectal swab specimens from antepartdmn women. Enriched cultures are obtained by 18 -24 hour incubation of vaginal/rectal swab specimens in selective broth medium, either Lim Broth [Todd Hewitt Broth supplemented with colistin (10 pg/mL) and nalidixic acid (15 pg/mt)] or TransVag Broth [Todd-Hewitt broth supplemented with gentamycin (8pg/mL) and nalidixic acid (15
The illumigene GBS assay utilizes loop-mediated isdithermal DNA amplification (LAMP) technology to detect Streptococcus ogoloctioe by targeting a segment of the Streptococcurs agoloctiae genome. Results from the iflumigene CBS assay can be used as an aid in establishing the CBS colonization status of antepartumn women. This assay is not intended to diagnose or monitor treatment for CBS infections.
The iflumnigene CBS assay does not provide susceptibility results. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.
illumigene Group BStreptococcus is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112125 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112125: Illumigene Group B Streptococcus ,External Control Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112125
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026