# K254166: MDx-Chex for BCN

- Pathway: 510(k) (Traditional)
- Applicant: Streck
- Decided: Mar 23, 2026 after 90 days
- Product code: PMN (Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays)
- Device class: 2
- Regulation: 21 CFR 866.3920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to DEN150058 (2016). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231223: MDx-Chex for BC-GN, Streck (2023) Summary page 5.

## Indications for use
MDx-Chex for BCN is intended for use as an external positive and negative assayed control to monitor the performance of the qualitative detection of Gram-negative bacteria and associated antimicrobial resistance genes, by the Diasorin LIAISON PLEX Gram-Negative Blood Culture assay on the LIAISON PLEX System. MDx-Chex for BCN Control 1 and Control 2 are composed of a buffered solution with stabilized erythrocytes and leukocytes in a matrix of blood culture media components. Control 1: Gram-negative bacteria: Acinetobacter baumannii, Haemophilus influenzae, Neisseria meningitidis, Pseudomonas aeruginosa, Stenotrophomonas maltophilia; genus: Acinetobacter spp., Pseudomonas spp.; antimicrobial resistance genes: KPC, NDM, and VIM. Control 2: Gram-negative bacteria: Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Klebsiella variicola, Morganella morganii, Serratia marcescens; family/genus: Enterobacteriaceae/Morganellaceae, Citrobacter spp., Enterobacter spp., Proteus spp., Salmonella spp.; antimicrobial resistance genes: CTX-M, IMP, MCR, OXA, and SME. This product is not intended to replace manufacturer controls provided with the device.

Source page: https://510kreport.com/device/K254166
Methodology: https://510kreport.com/methodology