# K022504: Idi-Strep B Assay

- Pathway: 510(k) (Traditional)
- Applicant: Infectio Diagnostic, Inc.
- Decided: Nov 18, 2002 after 112 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: 2 generations back to K936112 (1994). 2 ancestors in all.
17 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991828: Strep B Oia, Biostar, Inc. (1999) Summary page 2.
- (no number) broth culture: named in the summary without a submission number

## Most influential descendants
- K062948: Smart GBS and Smartcycle DX System and Software, Version 1.7B (2006), 14 descendants of its own
- K112125: Illumigene Group B Streptococcus ,External Control Kit (2011), 4 descendants of its own
- K090191: Handylab GBS Assay, Handylab Jaguar Instrument, Handylab Dna Extraction Strip, Handylab E3 Extraction Reagent, Handylab (2010), 4 descendants of its own
- K121539: Xpert GBS LB Genexpert DX Systems (GX-I, GX-IV) Genexpert DX Systems (GX-Xvi) Genexpert Infinity-48 System (900-XXXX) (2012), 2 descendants of its own
- K111860: BD Max GBS Assay, BD Max Instrument (2012), 2 descendants of its own

## Indications for use
IDI-Strep B™ assay is a qualitative in vitro diagnostic test for the rapid detection of Group B streptococcus (GBS) DNA in vaginal/rectal specimens from prepartum or intrapartum women. The test performed on the Smart Cycler® automated analyzer utilizes polymerase chain reaction (PCR) for the amplification of a cfb gene sequence of GBS recovered from clinical samples and fluorogenic target-specific hybridization for the detection of the amplified DNA. IDI-Strep B™ assay can be used to establish GBS colonisation status of prepartum and intrapartum women.

Source page: https://510kreport.com/device/K022504
Methodology: https://510kreport.com/methodology