# K162385: Rapidec Carba NP

- Pathway: 510(k) (Traditional)
- Applicant: Biomerieux S.A.
- Decided: Apr 27, 2017 after 245 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: 2 generations back to K850291 (1985). 3 ancestors in all.
2 later devices descend 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)
- K091766: Clearview Exact PBP2A Test, Model 891-000, Binax, Inc. (2010) Summary page 4.

## Most influential descendants
- K191889: NG-Test CARBA 5 (2019), 1 descendant of its own
- K243499: NG-Test® CTX-M MULTI (2025), 0 descendants of its own

## Indications for use
RAPIDEC® CARBA NP is a phenotypic (colorimetric) in vitro diagnostic test for the qualitative detection of carbapenemase enzymes in Enterobacteriaceae and Pseudomonas aeruginosa colonies that have elevated MIC values to any carbapenem. RAPIDEC® CARBA NP is performed on pure colonies grown on non-selective sheep blood agar culture media. RAPIDEC® CARBA NP is intended as an aid in the prevention and control of infection caused by carbapenemase-producing Enterobacteriaceae and Pseudomonas aeruginosa. RAPIDEC® CARBA NP is not intended to guide or monitor the treatment for these bacterial infections. A negative result does not preclude the presence of carbapenemase enzymes. The ability of RAPIDEC® CARBA NP to detect carbapenemase enzymes encoded by genetic markers other than KPC, NDM, OXA-48, VIM, and IMP has not been established. RAPIDEC® CARBA NP testing should be used in conjunction with other laboratory tests including antimicrobial susceptibility testing.

Source page: https://510kreport.com/device/K162385
Methodology: https://510kreport.com/methodology