510(k) · Cleared
ClearedXpert GBS LB Genexpert DX Systems (GX-I, GX-IV) Genexpert DX Systems (GX-Xvi) Genexpert Infinity-48 System (900-XXXX)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cepheid · NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Cleared on Nov 2, 2012 as substantially equivalent to K062948 (Cepheid, 2006) after a 162-day review. Its family tree reaches back 4 generations to 1994. 2 later devices descend from it.
- Decided
- Nov 2, 2012
- Review
- 162 days
- Class
- Class I
- Product code
- NJR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K936112 (1994). 2 later devices descend from it, 2 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 deviceK121539 Xpert GBS LB Genexpert DX Systems (GX-I, GX-IV) Genexpert DX Systems…Cepheid · 2012
- Descendant · cites it directly · 0 of its ownK203429 Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity SystemCepheid · 2022
- Descendant · cites it directly · 0 of its ownK181156 Panther Fusion GBS AssayDiagenode · 2018 · Recalled
Most influential descendants
Showing 2 of 2 · See allView 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) | K121539 | Xpert GBS LB Genexpert DX Systems (GX-I, GX-IV) Genexpert DX Systems (GX-Xvi)… | Cepheid | 2012 | — |
| +1 | K203429 | Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System | Cepheid | 2022 | — |
| +1 | K181156 | Panther Fusion GBS Assay | Diagenode | 2018 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2022 | 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…oduct code: NJR Classification Microbiology (83) Advisory Committee: Predicate Devices: Cepheid Smart GBS Assay [5 10O(k) #K062948] Device Description: The Cepheid Xpert GBS LB Assay is an automated in vitro diagnostic DNA test for the qualitative detection o… | 2006 |
What descends from it? (2)
2 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 18 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K203429 (Cepheid, 2022) has gone furthest, with 0 descendants 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. 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 Cepheid Xpert OBS LB Assay, performed on the Genepert@ Instrument Systems, is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA from enriched vaginal/rectal swab specimens, using hilly automated real-time polymerase chain reaction (PCR) with fluorogenic detection of the amplified DNA. Xpert GBS LB Assay testing is indicated as an aid in determining GBS colonization status in antepartumn women. The Xpert GBS LB…
Read the full statement (111 words)
The Cepheid Xpert OBS LB Assay, performed on the Genepert@ Instrument Systems, is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA from enriched vaginal/rectal swab specimens, using hilly automated real-time polymerase chain reaction (PCR) with fluorogenic detection of the amplified DNA. Xpert GBS LB Assay testing is indicated as an aid in determining GBS colonization status in antepartumn women.
The Xpert GBS LB Assay is used for antepartumn testing on enriched im broth cultures of vaginal/rectal swabs after 18-24 hours of incubation.
The Xpert GBS LB assay does not provide susceptibility results. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121539 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121539: Xpert GBS LB Genexpert DX Systems (GX-I, GX-IV) Genexpert DX Systems (GX-Xvi) Genexpert Infinity-48 System (900-XXXX).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121539
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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