# K254167: MDx-Chex for BCY

- Pathway: 510(k) (Traditional)
- Applicant: Streck, LLC
- Decided: Mar 17, 2026 after 84 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: 5 generations back to DEN150058 (2016). 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)
- K212576: MDx-Chex for BCID2, Streck, Inc. (2022) Summary page 5.

## Indications for use
MDx-Chex for BCY is intended for use as an external positive and negative assayed control to monitor the performance of the qualitative detection of yeast by the Diasorin LIAISON PLEX Yeast Blood Culture assay on the LIAISON PLEX System. The MDx-Chex for BCY Positive and Negative Controls are composed of a buffered solution with stabilized erythrocytes and leukocytes in a matrix of blood culture media components. Positive Control: Yeast: Candida albicans, Candida dubliniensis, Candida glabrata, Candida krusei, Candida parapsilosis, Candida tropicalis, Candida auris, Candida kefyr, Candida lipolytica, Candida lusitaniae, Candida guilliermondii, Cryptococcus neoformans/gattii, Candida famata, Candida haemulonii/duobushamulonii. Negative Control: buffered solution only. This product is not intended to replace manufacturer controls provided with the device.

Source page: https://510kreport.com/device/K254167
Methodology: https://510kreport.com/methodology