# K212576: MDx-Chex for BCID2

- Pathway: 510(k) (Traditional)
- Applicant: Streck, Inc.
- Decided: Jan 19, 2022 after 156 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: 4 generations back to DEN150058 (2016). 4 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200010: FilmArray BCID2 Control Panel M416, Maine Molecular Quality Controls, Inc. (2020) Summary page 4.

## Most influential descendants
- K231221: MDx-Chex for BC-GP (2023), 1 descendant of its own
- K231223: MDx-Chex for BC-GN (2023), 1 descendant of its own
- K260041: MDx-Chex for BCP (2026), 0 descendants of its own
- K254166: MDx-Chex for BCN (2026), 0 descendants of its own
- K254167: MDx-Chex for BCY (2026), 0 descendants of its own

## Indications for use
MDx-Chex for BCID2 is intended for use as an external positive and negative assayed control to monitor the performance of the qualitative detection of yeast, Gram positive and Gram negative bacteria, as well as associated antimicrobial resistance genes, by the BioFire FilmArray Blood Culture Identification 2 (BCID2) Panel on FilmArray systems. Control 1 - GN: Gram negative bacteria: Acinetobacter colcoaceticus-baumannii complex, Bacteroides fragilis, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Proteus spp., Salmonella spp., Serratia marcescens, Haemophilus influenza, Neisseria meningitides, Pseudomonas aeruginosa, Stenotrophomonas maltophilia; antimicrobial resistance genes: KPC, CTX-M, IMP, NDM, OXA-48-like, VIM, mcr- 1. Control 2 - GPY: Gram positive bacteria: Enterococcus Jaecalis, Enterococcus faecium, Listeria monocytogenes, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunesis, Streptococcus agalactiae, Streptococcus pneumonia, Streptococcus pyogenes; yeast: Candida albicans, Candida auris, Candida glabrata, Candida krusei, Candida parapsilosis, Candida tropicalis, Cryptococcus neoformans/gatti; antimicrobial resistance genes mecA/C and MREJ, vanA/B. This product is not intended to replace manufacturer controls provided with the device.

Source page: https://510kreport.com/device/K212576
Methodology: https://510kreport.com/methodology