510(k) · Cleared
ClearedXpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System
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 May 9, 2022 as substantially equivalent to K121539 (Cepheid, 2012) after a 535-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- May 9, 2022
- Review
- 535 days
- Class
- Class I
- Product code
- NJR
- Recalls
- None
- 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 backK121539 Xpert GBS LB Genexpert DX Systems (GX-I, GX-IV) Genexpert DX Systems…Cepheid · 2012
- This deviceK203429 Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity SystemCepheid · 2022
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 | K121539 | Xpert GBS LB Genexpert DX Systems (GX-I, GX-IV) Genexpert DX Systems (GX-Xvi)… | Cepheid | 2012 | — |
| 0 (this device) | K203429 | Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System | Cepheid | 2022 | — |
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
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 |
|---|---|---|---|
| * | K121539 | Xpert GBS LB Genexpert DX Systems (GX-I, GX-IV) Genexpert DX Systems (GX-Xvi) Genexpert…Summary page 4…say test system. Classification Advisory Microbiology (83) Panel Prescription Use Yes III. PREDICATE DEVICE Predicate Device Assay: Xpert GBS LB (K121539) Page |A5 - 1 of 17 Xpert® GB… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K121539.
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. 2022, 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 Xpert GBS LB XC test, performed on the GeneXpert® Instrument Systems, is an automated qualitative in vitro diagnostic test for the detection of Group B Streptococcus (GBS) DNA from enriched vaginal/rectal swab specimens, using real-time polymerase chain reaction (PCR). Xpert GBS LB XC testing is indicated as an aid in determining the GBS colonization status of antepartum women. • The Xpert GBS LB XC test is intended for antepartum testing on enriched…
Read the full statement (113 words)
The Xpert GBS LB XC test, performed on the GeneXpert® Instrument Systems, is an automated qualitative in vitro diagnostic test for the detection of Group B Streptococcus (GBS) DNA from enriched vaginal/rectal swab specimens, using real-time polymerase chain reaction (PCR).
Xpert GBS LB XC testing is indicated as an aid in determining the GBS colonization status of antepartum women.
• The Xpert GBS LB XC test is intended for antepartum testing on enriched Lim broth cultures of vaginal/rectal swabs after 18–24 hours of incubation
• The Xpert GBS LB XC test does not provide antimicrobial susceptibility test results. Culture is necessary to obtain isolates to perform susceptibility testing as recommended for penicillin-allergic women
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/K203429 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203429: Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203429
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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