# Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis Complex in Respiratory Specimens
> **Food and Drug Administration** · Final rule. · Published 2014-05-30 · Effective 2014-06-30 · 79 FR 31023
## Document
- **Document number:** 2014-12544
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 79 FR 31023
- **CFR reference:** 21 CFR 866
- **Publication date:** 2014-05-30
- **Effective date:** 2014-06-30
- **HHS docket:** Docket No. FDA-2013-N-0544
## Abstract

The Food and Drug Administration (FDA) is reclassifying nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens from class III (premarket approval) into class II (special controls). FDA is also issuing the special controls guideline entitled "Class II Special Controls Guideline: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex in Respiratory Specimens." These devices are intended to be used as an aid in the diagnosis of pulmonary tuberculosis.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2014/05/30/2014-12544/microbiology-devices-reclassification-of-nucleic-acid-based-systems-for-mycobacterium-tuberculosis)
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