UASure II Blood Uric Acid Monitoring System

Q: What is the product code of K242209?

The FDA product code is PTC – Uric Acid Test System For At Home Prescription Use, a Class I (low risk) device regulated under 21 CFR 862.1775.

FDA 510(k) K242209 · Apex BioTechnology Corp.

Substantially Equivalent

510(k) numberK242209

Submission

Device name: UASure II Blood Uric Acid Monitoring System
Applicant: Apex BioTechnology Corp.
Hsinchu, TW
Received: July 29, 2024
Decision date: April 4, 2025
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: PTC – Uric Acid Test System For At Home Prescription Use
Device class: Class I (low risk)
Regulation: 21 CFR 862.1775
Specialty: Clinical Chemistry

For the quantitative measurement of uric acid in home use settings by patients diagnosed with gout. This device is for prescription use only.

Other 510(k)s with product code PTC

510(k)	Device	Applicant	Decision
K181675	FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring SystemPTC · Traditional	Taidoc Technology Corporation	12/10/2018SE
K160990	Nova Max Uric Acid Monitoring SystemPTC · Traditional	Nova Biomedical Corporation	04/11/2017SE

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Questions and answers

When was UASure II Blood Uric Acid Monitoring System cleared by the FDA?

UASure II Blood Uric Acid Monitoring System (K242209) received a 510(k) decision of Substantially Equivalent on April 4, 2025, 249 days after the submission was received.

What is the product code of K242209?

The FDA product code is PTC – Uric Acid Test System For At Home Prescription Use, a Class I (low risk) device regulated under 21 CFR 862.1775.