Medical Devices; Immunology and Microbiology Devices; Classification of Multiplex Nucleic Acid Assay for Identification of Microorganisms and Resistance Markers From Positive Blood Cultures
fda-device · Food and Drug Administration · Rule · Published 2015-05-27 · Effective 2015-05-27 · 80 FR 30153
Document
Document number
2015-12741
Federal Register citation
80 FR 30153
CFR reference
21 CFR 866
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2015-05-27
Effective date
2015-05-27
HHS docket
Docket No. FDA-2015-N-1072
Abstract
The Food and Drug Administration (FDA) is classifying multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures 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 multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures. 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.