Cleared Traditional

K253453 - Metrix COVID Test

Also marketed or referenced as:
Metrix COVID Test Pro

K253453 is an FDA 510(k) clearance for Metrix COVID Test, manufactured by Aptitude Medical Systems, Inc.. The device is a Class 2 Microbiology device with product code QWB cleared through the Traditional 510(k) pathway after a 305-day FDA review.

K253453 · Aptitude Medical Systems, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
305d
Days
Class 2
Risk

K253453 is an FDA 510(k) clearance for the Metrix COVID Test. Classified as Over-the-counter Molecular Test To Detect Sars-cov-2 From Clinical Specimens (product code QWB), Class II - Special Controls.

Submitted by Aptitude Medical Systems, Inc. (Goleta, US). The FDA issued a Cleared decision on August 7, 2026 after a review of 305 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3984 - 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. Elevated predicate reliance profile. 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 Aptitude Medical Systems, Inc. devices

FDA 510(k) Submission Details - K253453

510(k) Number K253453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2025
Decision Date August 07, 2026
Days to Decision 305 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
203d slower than avg
Panel avg: 102d · This submission: 305d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QWB Device Classification - Class 2, Special Controls

Product Code QWB Over-the-counter Molecular Test To Detect Sars-cov-2 From Clinical Specimens
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3984
Definition An Over-the-counter Molecular Test To Detect Sars-cov-2 Is An In Vitro Diagnostic Device For The Detection Of Sars-cov-2 In Clinical Specimens To Aid In The Diagnosis Of Sars-cov-2 Infection. The Device Is Intended To Be Used By Lay Users And Without Health Care Provider (hcp) Intervention In Home Settings Or Similar Environments.
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.