# Medical Devices; Exemption From Premarket Notification; Method, Metallic Reduction, Glucose (Urinary, Nonquantitative) Test System in a Reagent Tablet Format
> **Food and Drug Administration** · Final order. · Published 2016-10-04 · Effective 2016-10-04 · 81 FR 68295
## Document
- **Document number:** 2016-23901
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 81 FR 68295
- **CFR reference:** 21 CFR 862
- **Publication date:** 2016-10-04
- **Effective date:** 2016-10-04
- **HHS docket:** Docket No. FDA-2016-P-0159
## Abstract

The Food and Drug Administration (FDA) is publishing 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 classified as class II devices as urinary glucose (nonquantitative) test system (hereinafter referred to as "copper reduction tablet test"). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia. FDA is publishing this order in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2016/10/04/2016-23901/medical-devices-exemption-from-premarket-notification-method-metallic-reduction-glucose-urinary)
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