FDA 510(k)

Metrix COVID Test; Metrix COVID Test Pro

K-Number: K253453 · 2026-08-07

Decision Date2026-08-07

Product CodeQWB

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Metrix COVID Test; Metrix COVID Test Pro is the device name listed in this FDA 510(k) record. The listed applicant is Aptitude Medical Systems, Inc.. It received FDA 510(k) clearance on 2026-08-07 under 510(k) number K253453. The device is classified under product code QWB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Metrix COVID Test; Metrix COVID Test Pro?

Metrix COVID Test; Metrix COVID Test Pro is a medical device that received FDA 510(k) clearance on 2026-08-07. The listed applicant is Aptitude Medical Systems, Inc.. The 510(k) number is K253453.

When did Metrix COVID Test; Metrix COVID Test Pro receive FDA 510(k) clearance?

Metrix COVID Test; Metrix COVID Test Pro received FDA 510(k) clearance on 2026-08-07, under 510(k) number K253453.

Who is the listed applicant for Metrix COVID Test; Metrix COVID Test Pro?

The FDA 510(k) record lists Aptitude Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Metrix COVID Test; Metrix COVID Test Pro?

The FDA product code for Metrix COVID Test; Metrix COVID Test Pro is QWB.

Related Devices (Code: QWB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232643Cue COVID-19 Molecular TestCue Health, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.