# K111860: BD Max GBS Assay, BD Max Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Feb 16, 2012 after 231 days
- Product code: NJR (Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test)
- Device class: 1
- Regulation: 21 CFR 866.3740
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K936112 (1994). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090191: Handylab GBS Assay, Handylab Jaguar Instrument, Handylab Dna Extraction Strip, Handylab E3 Extraction Reagent, Handylab, Handylab, Inc. (2010) Summary page 2.

## Most influential descendants
- K170557: GenePOC GBS LB (2017), 1 descendant of its own
- K182467: Simplexa GBS Direct, Simplexa GBS Positive Control Pack (2018), 0 descendants of its own

## Recalls of this device
- Sep 23, 2025 · Class II · Z-0238-2026: 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 
- Dec 19, 2024 · Class II · Z-1004-2025: Potential for signal drift in specific lots of BD PCR Cartridges.
- Oct 31, 2024 · Class II · Z-0590-2025: 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 
- Jul 29, 2015 · Class II · Z-1864-2017: 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 u
- May 31, 2013 · Class III · Z-1662-2013: 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: 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: Clinical diagnostic instrument may exhibit minor defects, which could lead to erroneous test results.

## Indications for use
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.

Source page: https://510kreport.com/device/K111860
Methodology: https://510kreport.com/methodology