510(k) · Cleared
ClearedHandylab GBS Assay, Handylab Jaguar Instrument, Handylab Dna Extraction Strip, Handylab E3 Extraction Reagent, Handylab
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Handylab, Inc. · NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Cleared on May 27, 2010 as substantially equivalent to K062948 (Cepheid, 2006) after a 485-day review. Its family tree reaches back 4 generations to 1994. 4 later devices descend from it.
- Decided
- May 27, 2010
- Review
- 485 days
- Class
- Class I
- Product code
- NJR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K936112 (1994). 4 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 deviceK090191 Handylab GBS Assay, Handylab Jaguar Instrument, Handylab Dna…Handylab, Inc. · 2010
- Descendant · cites it directly · 2 of its ownK111860 BD Max GBS Assay, BD Max InstrumentBecton, Dickinson & CO · 2012 · Recalled
- Descendant · 2 generations on · 1 of its ownK170557 GenePOC GBS LBGenepoc, Inc. · 2017
- Descendant · 3 generations on · 0 of its ownK182467 Simplexa GBS Direct, Simplexa GBS Positive Control PackDiasorin Molecular, LLC · 2018
- Descendant · cites it directly · 0 of its ownK173725 NeuMoDx GBS AssayNeumodx Molecular, Inc. · 2018
Most influential descendants
Showing 4 of 4 · See all- K111860BD Max GBS Assay, BD Max InstrumentBecton, Dickinson & CO · 2012 · cites it directly2descendants
- K170557GenePOC GBS LBGenepoc, Inc. · 2017 · 2 generations on1descendant
- K182467Simplexa GBS Direct, Simplexa GBS Positive Control PackDiasorin Molecular, LLC · 2018 · 3 generations on0descendants
- K173725NeuMoDx GBS AssayNeumodx Molecular, Inc. · 2018 · cites it directly0descendants
View 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) | 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 |
| +2 | K170557 | GenePOC GBS LB | Genepoc, Inc. | 2017 | — |
| +3 | K182467 | Simplexa GBS Direct, Simplexa GBS Positive Control Pack | Diasorin Molecular, LLC | 2018 | — |
| +1 | K173725 | NeuMoDx GBS Assay | Neumodx Molecular, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 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…PTOCOCCUS, DIRECT SPECIMEN TEST Regulation number: 866.3740 CLASS I Classification Panel MICROBIOLOGY Predicate Device(s): K062948 Cepheid Smart GBS Assay DEVICE DESCRIPTION INTENDED USE The BID MAX Tm GBS Assay as imple" ented on the BID MAX'TM System is… | 2006 |
What descends from it? (4)
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 16 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K111860 (Becton, Dickinson & CO, 2012) has gone furthest, with 2 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. 2010, 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 BD MAX™ GBS Assay as implemented on the BD MAX™ System is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA in Lim Broth cultures after incubation for greater than or equal to (≥)18 hours, obtained from vaginal and rectal swab specimens from antepartum pregnant women. The test incorporates automated DNA extraction to isolate the target nucleic acid from the specimen and real-time polymerase chain reaction (PCR)…
Read the full statement (141 words)
The BD MAX™ GBS Assay as implemented on the BD MAX™ System is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA in Lim Broth cultures after incubation for greater than or equal to (≥)18 hours, obtained from vaginal and rectal swab specimens from antepartum pregnant women. The test incorporates automated DNA extraction to isolate the target nucleic acid from the specimen and real-time polymerase chain reaction (PCR) to detect a 124 bp region of the cfb gene sequence of the Streptococcus agalactiae chromosome. Results from the BD MAX™ GBS Assay can be used as an aid in determining colonization status in antepartum women.
The BD MAX™ GBS Assay does not provide susceptibility results. Cultured isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women. Subculture to solid media for additional testing when indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090191 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090191: Handylab GBS Assay, Handylab Jaguar Instrument, Handylab Dna Extraction Strip, Handylab E3 Extraction Reagent, Handylab.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090191
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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