510(k) · Cleared
ClearedGenePOC GBS LB
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genepoc, Inc. · NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Cleared on May 25, 2017 as substantially equivalent to K111860 (Becton, Dickinson & CO, 2012) after a 90-day review. Its family tree reaches back 6 generations to 1994. 1 later device descends from it.
- Decided
- May 25, 2017
- Review
- 90 days
- Class
- Class I
- Product code
- NJR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K936112 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK936112 Strep B OiaBiostar, Inc. · 1994
- 5 generations backK991828 Strep B OiaBiostar, Inc. · 1999
- 4 generations backK022504 Idi-Strep B AssayInfectio Diagnostic, Inc. · 2002
- 3 generations backK062948 Smart GBS and Smartcycle DX System and Software, Version 1.7BCepheid · 2006
- 2 generations backK090191 Handylab GBS Assay, Handylab Jaguar Instrument, Handylab Dna…Handylab, Inc. · 2010
- 1 generation backK111860 BD Max GBS Assay, BD Max InstrumentBecton, Dickinson & CO · 2012 · Recalled
- This deviceK170557 GenePOC GBS LBGenepoc, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK182467 Simplexa GBS Direct, Simplexa GBS Positive Control PackDiasorin Molecular, LLC · 2018
Most influential descendants
Showing 1 of 1 · See all- K182467Simplexa GBS Direct, Simplexa GBS Positive Control PackDiasorin Molecular, LLC · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K936112 | Strep B Oia | Biostar, Inc. | 1994 | — |
| −5 | K991828 | Strep B Oia | Biostar, Inc. | 1999 | — |
| −4 | K022504 | Idi-Strep B Assay | Infectio Diagnostic, Inc. | 2002 | — |
| −3 | K062948 | Smart GBS and Smartcycle DX System and Software, Version 1.7B | Cepheid | 2006 | — |
| −2 | K090191 | Handylab GBS Assay, Handylab Jaguar Instrument, Handylab Dna Extraction Strip… | Handylab, Inc. | 2010 | — |
| −1 | K111860 | BD Max GBS Assay, BD Max Instrument | Becton, Dickinson & CO | 2012 | 7 |
| 0 (this device) | K170557 | GenePOC GBS LB | Genepoc, Inc. | 2017 | — |
| +1 | K182467 | Simplexa GBS Direct, Simplexa GBS Positive Control Pack | Diasorin Molecular, LLC | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K111860 | BD Max GBS Assay, BD Max InstrumentSummary page 6…transferred, and/or stored by the user. H. SUBSTANTIAL EQUIVALENCE INFORMATION: 1. Predicate Device Name: BD MAX™ GBS Assay 2. Predicate 510(k) Number: K111860 3. Comparison with Predicate: Item GenePOC GBS LB BD MAX GBS Assay… | 2012 |
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 |
|---|---|---|---|
| K182467 | Simplexa GBS Direct, Simplexa GBS Positive Control Pack | 2018 | 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 23 years and passes through 6 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K182467 (Diasorin Molecular, LLC, 2018) has gone furthest, with 0 descendants of its own.
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. 2017, 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 GenePOC™ GBS LB assay performed on the revogene™ instrument is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA from 18-24 hour LIM broth enrichments of vaginal/rectal specimen swabs obtained from pregnant women. The GenePOC GBS LB assay utilizes automated sample processing and real-time polymerase chain reaction (PCR) to detect a cfb gene sequence specific to the Streptococcus agalactiae genome. The GenePOC…
Read the full statement (111 words)
The GenePOC™ GBS LB assay performed on the revogene™ instrument is a qualitative in vitro diagnostic test designed to
detect Group B Streptococcus (GBS) DNA from 18-24 hour LIM broth enrichments of vaginal/rectal specimen swabs
obtained from pregnant women. The GenePOC GBS LB assay utilizes automated sample processing and real-time
polymerase chain reaction (PCR) to detect a cfb gene sequence specific to the Streptococcus agalactiae genome.
The GenePOC GBS LB assay is indicated for the identification of antepartum GBS colonization and does not provide
susceptibility results. It is not intended to diagnose or monitor treatment of GBS infection. 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/K170557 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170557: GenePOC GBS LB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170557
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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