Cleared Traditional

K231223 - MDx-Chex for BC-GN (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231223 · Streck · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2023
Decision
90d
Days
Class 2
Risk

K231223 is an FDA 510(k) clearance for the MDx-Chex for BC-GN. Classified as Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays (product code PMN), Class II - Special Controls.

Submitted by Streck (La Vista, US). The FDA issued a Cleared decision on July 27, 2023 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3920 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Streck devices

Submission Details

510(k) Number K231223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2023
Decision Date July 27, 2023
Days to Decision 90 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 102d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3920
Definition Assayed External Quality Control Material To Monitor The Performance Of Microbiology Nucleic Acid Assays For In Vitro Diagnostic Use.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays

All 29
Devices cleared under the same product code (PMN) and FDA review panel - the closest regulatory comparables to K231223.
MDx-Chex for BCP
K260041 · Streck, LLC · Mar 2026
MDx-Chex for BCN
K254166 · Streck · Mar 2026
MDx-Chex for BCY
K254167 · Streck, LLC · Mar 2026
FilmArray GI Control Panel M238
K251526 · Maine Molecular Quality Controls, Inc. · Aug 2025
SPOTFIRE RSP Pos & Neg Controls
K241289 · Maine Molecular Quality Controls, Inc. · May 2024
SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)
K233611 · Maine Molecular Quality Controls, Inc. · Mar 2024