510(k) · Cleared
Recalled · Class II · 2025Illumigene Group B Streptococcus Carrot Broth Claim
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 May 1, 2012 as substantially equivalent to K112125 (Meridian Bioscience, Inc., 2011) after a 25-day review. Its family tree reaches back 5 generations to 1994. It has been recalled once.
- Decided
- May 1, 2012
- Review
- 25 days
- Class
- Class I
- Product code
- NJR
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K936112 (1994). No later device cites it as a predicate yet.
- Root · 5 generations backK936112 Strep B OiaBiostar, Inc. · 1994
- 4 generations backK991828 Strep B OiaBiostar, Inc. · 1999
- 3 generations backK022504 Idi-Strep B AssayInfectio Diagnostic, Inc. · 2002
- 2 generations backK062948 Smart GBS and Smartcycle DX System and Software, Version 1.7BCepheid · 2006
- 1 generation backK112125 Illumigene Group B Streptococcus ,External Control KitMeridian Bioscience, Inc. · 2011
- This deviceK121044 Illumigene Group B Streptococcus Carrot Broth ClaimMeridian Bioscience, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K936112 | Strep B Oia | Biostar, Inc. | 1994 | — |
| −4 | K991828 | Strep B Oia | Biostar, Inc. | 1999 | — |
| −3 | K022504 | Idi-Strep B Assay | Infectio Diagnostic, Inc. | 2002 | — |
| −2 | K062948 | Smart GBS and Smartcycle DX System and Software, Version 1.7B | Cepheid | 2006 | — |
| −1 | K112125 | Illumigene Group B Streptococcus ,External Control Kit | Meridian Bioscience, Inc. | 2011 | — |
| 0 (this device) | K121044 | Illumigene Group B Streptococcus Carrot Broth Claim | Meridian Bioscience, Inc. | 2012 | — |
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 |
|---|---|---|---|
| * | K112125 | Illumigene Group B Streptococcus ,External Control KitSummary page 3…lity Control. J.Substantial Equivalence Information: 1. Predicate device name(s): illumigene Group BStreptococcus (GBS) Assay 2. Predicate 510(k) numbers: K112 125 3. Comparison with predicates: Similarities… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 7, 2025 | Class II | Z-0569-2026 | Nonconforming Material/Component | The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- None of the 5 ancestors has a recall.
- 2 other devices also cite its predicate K112125.
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. 2012, 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 B Streptococcus (GBS) assay, performed on the illumipro-10, is a qualitative in vitro diagnostic for the detection of Streptococcus agalactiae in enriched cultures obtained from vaginal/rectal swab specimens from antepartum women. Enriched cultures are obtained by 18-24 hour incubation of vaginal/rectal swab specimens in selective broth medium, either Lim Broth, TransVag Broth or Carrot Broth. The illumigene GBS assay utilizes…
Read the full statement (161 words)
The illumigene Group B Streptococcus (GBS) assay, performed on the illumipro-10, is a qualitative in vitro diagnostic for the detection of Streptococcus agalactiae in enriched cultures obtained from vaginal/rectal swab specimens from antepartum women. Enriched cultures are obtained by 18-24 hour incubation of vaginal/rectal swab specimens in selective broth medium, either Lim Broth, TransVag Broth or Carrot Broth.
The illumigene GBS assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus agalactiae by targeting a segment of the Streptococcus agalactiae genome. Results from the illumigene GBS assay can be used as an aid in establishing the GBS colonization status of antepartum women. This assay is not intended to diagnose or monitor treatment for GBS infections.
The illumigene GBS assay does not provide susceptibility results. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.
illumigene Group B Streptococcus is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K121044 · printed Nov 5, 2026
Cite this page
510(k) Report. “K121044: Illumigene Group B Streptococcus Carrot Broth Claim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121044
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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