510(k) · Cleared
Recalled · Class II · 2025BD Max GBS Assay, BD Max Instrument
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson & CO · NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Cleared on Feb 16, 2012 as substantially equivalent to K090191 (Handylab, Inc., 2010) after a 231-day review. Its family tree reaches back 5 generations to 1994. 2 later devices descend from it. It has been recalled 7 times.
- Decided
- Feb 16, 2012
- Review
- 231 days
- Class
- Class I
- Product code
- NJR
- Recalls
- 7
- Predicates
- 1
Its longest line of descent runs back 5 generations to K936112 (1994). 2 later devices descend 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 backK090191 Handylab GBS Assay, Handylab Jaguar Instrument, Handylab Dna…Handylab, Inc. · 2010
- This deviceK111860 BD Max GBS Assay, BD Max InstrumentBecton, Dickinson & CO · 2012
- Descendant · cites it directly · 1 of its ownK170557 GenePOC GBS LBGenepoc, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK182467 Simplexa GBS Direct, Simplexa GBS Positive Control PackDiasorin Molecular, LLC · 2018
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 |
|---|---|---|---|---|---|
| −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 | K090191 | Handylab GBS Assay, Handylab Jaguar Instrument, Handylab Dna Extraction Strip… | Handylab, Inc. | 2010 | — |
| 0 (this device) | K111860 | BD Max GBS Assay, BD Max Instrument | Becton, Dickinson & CO | 2012 | — |
| +1 | K170557 | GenePOC GBS LB | Genepoc, Inc. | 2017 | — |
| +2 | 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 |
|---|---|---|
| 2017 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K090191 | Handylab GBS Assay, Handylab Jaguar Instrument, Handylab Dna Extraction Strip, Handylab…Summary page 2…Classification Panel: Microbiology, Clinical Chemistry BD MAX GBS Assay Migration 510(k) Summary Predicate Device(s): K090191 Nucleic Acid Amplification Assay System, Group BStreptococcus, Direct Specimen Test DE… | 2010 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170557 | GenePOC GBS LB | 2017 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 23, 2025 | Class II | Z-0238-2026 | Software design | Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may… |
| Dec 19, 2024 | Class II | Z-1004-2025 | Under Investigation by firm | Potential for signal drift in specific lots of BD PCR Cartridges. |
| Oct 31, 2024 | Class II | Z-0590-2025 | Software design | BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of… |
| Jul 29, 2015 | Class II | Z-1864-2017 | Software design | The BD MAX System software version 4.44A contains a software anomaly that has the potential to affect some Open System Reagent (OSR) customers utilizing User Defined Protocol (UDP) assays. Customers utilizing only IVD assays are not… |
| May 31, 2013 | Class III | Z-1662-2013 | Component change control | Electrical power module installed on some in vitro diagnostic instruments does not meet industry standards as labeled. |
| Dec 11, 2012 | Class II | Z-0976-2013 | Process control | Cartridges are not sealing properly during PCR testing and may cause false results, indeterminates and/or invalid runs. |
| Sep 18, 2012 | Class II | Z-0701-2013 | Device Design | Clinical diagnostic instrument may exhibit minor defects, which could lead to erroneous test results. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K170557 (Genepoc, Inc., 2017) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K090191.
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 EID MAXTM GBS Assay as implemented on the BID MAX TM 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-rectal swab specimens from antepartumn pregnant women. The test incorporates automated DNA extraction to isolate the target nucleic acid from the specimen and real-time polymerase chain reaction…
Read the full statement (194 words)
The EID MAXTM GBS Assay as implemented on the BID MAX TM 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-rectal swab specimens from antepartumn 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 BID MAX"' GBS Assay can be used as an aid in determining colonization status inantepartumn women.
The RID MAXIM GES 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.
The 80D MAX Tm System isintended for invitro diagnostic (IVO) use inperforming FDA cleared or approved nucleic acid testing inclinical laboratories. The ED MAX System iscapable of automated extraction and purification of nucleic acids from multiple specimren types as well as the automated amplification and detection of target nucleic acid sequences by fluorescence-based PCR.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111860 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111860: BD Max GBS Assay, BD Max Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111860
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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