MDx-Chex for BCN— 510(k) K254166

Name: FDA 510(k) clearance K254166
Creator: U.S. Food and Drug Administration
Published: 2026-03-23

Substantially Equivalent

Streck

FDA 510(k) clearance K254166 for MDx-Chex for BCN, Substantially Equivalent on 2026-03-23. Applicant: Streck. Device class: 2.

Summary

Streck's MDx-Chex for BCN is filed under PMN, assayed external control material for microbiology nucleic acid amplification (NAT) assays. The record doesn't describe the product beyond its name and that code name.

Class II, 21 CFR 866.3920. Microbiology is both the classification panel and the review panel. It was a Traditional 510(k).

Streck filed from La Vista, Nebraska. The decision came 90 calendar days after receipt (December 23, 2025 to March 23, 2026).

Clearance details

Applicant: Streck
Product code: Product code PMN
Device class: Class 2
Regulation: 21 CFR 866.3920
Advisory panel: Microbiology
Date received: 2025-12-23
Decision date: 2026-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Vista, NE, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.