# K243499: NG-Test® CTX-M MULTI

- Pathway: 510(k) (Traditional)
- Applicant: Ng Biotech
- Decided: Jun 4, 2025 after 204 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: 4 generations back to K850291 (1985). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191889: NG-Test CARBA 5, Ng Biotech (2019) Summary page 5.

## Indications for use
NG-Test® CTX-M MULTI is an in vitro rapid and visual immunochromatographic assay for the qualitative detection of CTX-M enzymes (groups 1, 2, 8, 9, and 25) from pure colonies of Enterobacterales suspected of ESBL production when grown on the following media: • 5% sheep blood agar or MacConkey agar (16-24 hours) • HardyCHROM™ ESBL agar (18-24 hours) The NG-Test® CTX-M MULTI is intended as an aid for infection control in the detection of CTX-M enzymes-producing organisms (Enterobacterales) in healthcare settings. NG-Test® CTX-M MULTI is not intended to guide or monitor treatment. A positive or negative NG- Test® CTX-M MULTI test result does not rule out the presence of other mechanisms of antibiotic resistance. NG-Test® CTX-M MULTI should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing.

Source page: https://510kreport.com/device/K243499
Methodology: https://510kreport.com/methodology