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# Petition Denial on 510(k) Exemption for Reagent Tablet
- URL: https://www.fdaweb.com/petition-denial-on-510-k-exemption-for-reagent-tablet/
- Published: 2016-10-04T12:00:00.000Z
- Updated: 2026-09-14T21:36:44.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136987

*Federal Register* Final Order: FDA has published an order denying a petition requesting exemption from the premarket notification requirements for “method, metallic reduction, glucose (urinary, nonquantitative)”devices that are in a reagent tablet format and are currently classified as Class 2 devices. The devices are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia. After reviewing the petition, the agency determined that the petition failed to provide information to demonstrate that premarket notification is not necessary to provide a reasonable assurance of the device’s safety and effectiveness. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-10-04/pdf/2016-23901.pdf?ref=fdaweb.com).