# K090191: Handylab GBS Assay, Handylab Jaguar Instrument, Handylab Dna Extraction Strip, Handylab E3 Extraction Reagent, Handylab

- Pathway: 510(k) (Traditional)
- Applicant: Handylab, Inc.
- Decided: May 27, 2010 after 485 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K936112 (1994). 4 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062948: Smart GBS and Smartcycle DX System and Software, Version 1.7B, Cepheid (2006) Summary page 1.

## Most influential descendants
- K111860: BD Max GBS Assay, BD Max Instrument (2012), 2 descendants of its own
- 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
- K173725: NeuMoDx GBS Assay (2018), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K090191
Methodology: https://510kreport.com/methodology