Reflotron Creatinine Test Tabs

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K913105 ↗

FDA Product Code

JFY

Device Class

Class II

Regulation

21 CFR Part 862.1225

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the Reflotron Creatinine Test Tabs used for?

  The Reflotron Creatinine Test Tabs are an in vitro diagnostic device that uses an enzymatic colorimetric assay to measure creatinine levels in serum or plasma, aiding in the assessment of renal function and detection of conditions such as chronic kidney disease or acute renal failure.

• How is the Reflotron Creatinine Test Tabs supplied and is it reusable?

  The device is supplied as single-use test tabs, with each tab designed for one-time use only and requiring no additional reagents beyond the patient sample, making it unsuitable for reuse.

• What regulatory pathway was used for the Reflotron Creatinine Test Tabs?

  The Reflotron Creatinine Test Tabs received FDA 510(k) clearance under submission K913105, classified as substantially equivalent to a predicate device, and is regulated as a Class II medical device with special controls under product code JFY.

• In what settings is the Reflotron Creatinine Test Tabs intended to be used?

  The device is intended for use in clinical chemistry laboratories and point-of-care settings, where rapid creatinine measurement is needed to support renal function assessment.

• What special controls apply to the Reflotron Creatinine Test Tabs based on its classification?

  As a Class II device under product code JFY for enzymatic creatinine measurement, the Reflotron Creatinine Test Tabs are subject to special controls, which include performance standards, labeling requirements, and post-market surveillance as mandated by FDA regulation 862.1225.