# K191889: NG-Test CARBA 5

- Pathway: 510(k) (Traditional)
- Applicant: Ng Biotech
- Decided: Oct 2, 2019 after 79 days
- Product code: PTJ (Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K850291 (1985). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162385: Rapidec Carba NP, Biomerieux S.A. (2017) Summary page 3.

## Most influential descendants
- K243499: NG-Test® CTX-M MULTI (2025), 0 descendants of its own

## Indications for use
NG-Test CARBA 5 is an in vitro rapid and visual multiplex immunochromatographic assay for the qualitative detection and differentiation of five common carbapenemases (KPC, OXA-48-like, VIM, IMP and NDM) from carbapenem non-susceptible pure bacterial colonies when grown on the following media:  5% sheep blood agar or MacConkey agar (16-24 hours) for testing Enterobacteriaceae and Pseudomonas aeruginosa  HardyCHROM™ CRE agar (18-24 hours) for testing E. coli and KES (Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Enterobacter cloacae complex, and Serratia marcescens). The NG-Test CARBA 5 is intended as an aid for infection control in the detection of carbapenemase-producing Enterobacteriaceae and Pseudomonas aeruginosa in healthcare settings. NG-Test CARBA 5 is not intended to guide or monitor treatment for carbapenem non-susceptible bacterial infections. A positive or negative NG-Test CARBA 5 test result does not rule out the presence of other mechanisms of antibiotic resistance. NG-Test CARBA 5 should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing.

Source page: https://510kreport.com/device/K191889
Methodology: https://510kreport.com/methodology