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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / August 2026 / K253453

510(k) cleared

Metrix COVID Test; Metrix COVID Test Pro

Aptitude Medical Systems, Inc. · Aug 7, 2026 · K253453

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.

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