# Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of Hemoglobin A1c Test System
> **Food and Drug Administration** · Final order. · Published 2014-08-25 · Effective 2014-09-24 · 79 FR 50549
## Document
- **Document number:** 2014-20022
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 79 FR 50549
- **CFR reference:** 21 CFR 862
- **Publication date:** 2014-08-25
- **Effective date:** 2014-09-24
- **HHS docket:** Docket No. FDA-2014-N-1112
## Abstract

The Food and Drug Administration (FDA) is classifying hemoglobin A1c test system into class II (special controls). The special controls that will apply to this device are identified in this order and will be part of the codified language for the hemoglobin A1c test system classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2014/08/25/2014-20022/medical-devices-clinical-chemistry-and-clinical-toxicology-devices-classification-of-hemoglobin-a1c)
---
*AI Analytics · CC0 1.0*