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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / August 2026 / K253453

510(k) cleared

Metrix COVID Test; Metrix COVID Test Pro

Aptitude Medical Systems, Inc. · Aug 7, 2026 · K253453 · In the directory

FDA cleared the Metrix COVID Test; Metrix COVID Test Pro from Aptitude Medical Systems, Inc. on Aug 7, 2026 under K253453, a traditional 510(k). The device falls under product code QWB, Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens, regulated at 21 CFR 866.3984 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Oct 6, 2025. The decision came 305 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Aptitude Medical Systems, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253453?

K253453 is the FDA 510(k) for Metrix COVID Test; Metrix COVID Test Pro, submitted by Aptitude Medical Systems, Inc.. FDA's decision date was Aug 7, 2026, under product code QWB (Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens).

Who makes the Metrix COVID Test; Metrix COVID Test Pro?

Aptitude Medical Systems, Inc., based in Goleta, CA, is the applicant of record for K253453. The company is listed in the MedDevice Startups directory.

How long did the K253453 review take?

FDA received the submission on Oct 6, 2025 and issued its decision on Aug 7, 2026, 305 days later.

← All decisions in August 2026

Sources

In the startup directory

Aptitude Medical Systems

Diagnostics & IVD · Goleta, CA