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# Biorex Petitions to Exempt Some Devices from 510(k)
- URL: https://www.fdaweb.com/biorex-petitions-to-exempt-some-devices-from-510-k/
- Published: 2016-01-20T12:00:00.000Z
- Updated: 2026-09-15T02:28:58.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5134484

> Biorex Labs is petitioning FDA to exempt devices classified as “Method, Metallic Reduction, Glucose (Urinary, Non Quantitative) in a reagent tablet format from the 510(k) premarket notification requirement. The company’s [request](http://www.regulations.gov/?ref=fdaweb.com#!documentDetail;D=FDA-2016-P-0159-0001) says that the device is intended to non-quantitatively or semiquantitatively detect/measure reducing sugars such as glucose in urine. Device measurements are used in diagnosing, monitoring, and treating metabolic disorders such as diabetes mellitus, it says. The devices are classified as Class 2 devices, the letter says, and have been in use for over 70 years without any reports of patient or user injury within the last 10 years.