510(k) · Cleared
ClearedAmplivue GBS Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quidel Corporation · NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Cleared on Dec 20, 2013 as substantially equivalent to K112125 (Meridian Bioscience, Inc., 2011) after a 36-day review. Its family tree reaches back 5 generations to 1994. 1 later device descends from it.
- Decided
- Dec 20, 2013
- Review
- 36 days
- Class
- Class I
- Product code
- NJR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K936112 (1994). 1 later device descends from it, 1 citing it directly.
- 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 deviceK133503 Amplivue GBS AssayQuidel Corporation · 2013
- Descendant · cites it directly · 0 of its ownK173250 Solana GBS AssayQuidel Corporation · 2017
Most influential descendants
Showing 1 of 1 · See all- K173250Solana GBS AssayQuidel Corporation · 2017 · cites it directly0descendants
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) | K133503 | Amplivue GBS Assay | Quidel Corporation | 2013 | — |
| +1 | K173250 | Solana GBS Assay | Quidel Corporation | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K112125 | Illumigene Group B Streptococcus ,External Control KitSummary page 4…ce Information: 1. Predicate device name(s): illurnigene®DCBS Assay, external control kit (Meridian Bioscience, Inc.) 2. Predicate 510(k) number(s): K1 12125 4… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173250 | Solana GBS Assay | 2017 | 0 |
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 19 years and passes through 5 companies; a new generation was cleared every 4.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K173250 (Quidel Corporation, 2017) has gone furthest, with 0 descendants of its own.
- 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. 2013, 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 AmpliVue® GBS Assay is a qualitative in vitro diagnostic test for the rapid detection of Group B Streptococcus from vaginal/rectal swabs from antepartum women following 18 to 24 hours of incubation in an LIM enrichment broth culture. The AmpliVue® GBS Assay utilizes helicase-dependent amplification (HDA) of the Thiolase (atoB) gene sequence and a self-contained disposable amplification detection device that allows for manual evaluation of assay…
Read the full statement (127 words)
The AmpliVue® GBS Assay is a qualitative in vitro diagnostic test for the rapid detection of Group B Streptococcus from vaginal/rectal swabs from antepartum women following 18 to 24 hours of incubation in an LIM enrichment broth culture. The AmpliVue® GBS Assay utilizes helicase-dependent amplification (HDA) of the Thiolase (atoB) gene sequence and a self-contained disposable amplification detection device that allows for manual evaluation of assay results. Results can be used as an aid in determining the colonization status of antepartum women.
The AmpliVue® GBS Assay does not provide susceptibility results. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.
The AmpliVue® GBS Assay 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/K133503 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133503: Amplivue GBS Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133503
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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