21 CFR 866.3967 — Device To Detect Microbial Colonization Directly From Clinical Specimens.
Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3967
Identification
The Simplexa C. auris RT-PCR system is a real-time polymerase chain reaction (RT-PCR) assay intended for use on the LIAISON MDX instrument for the direct in vitro qualitative detection of Candida auris DNA from a composite swab of bilateral axilla/groin from patients suspected of C. auris colonization. The system consists of the Simplexa C. auris Direct (assay kit), Simplexa C. auris Positive Control Pack, and Simplexa C. auris Sample Prep Kit.
Classification Rationale
Class II (special controls). The device is classified under 21 CFR 866.3967 - Device to detect microbial colonization directly from clinical specimens.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| SBT | Device To Detect Microbial Colonization Directly From Clinical Specimens. | 2 | 1 |
Special Controls
SBT — Device To Detect Microbial Colonization Directly From Clinical Specimens.
The De Novo request is granted and the device is classified under the following and subject to the special controls identified in the letter granting the De Novo request:
De Novo Order DEN230092
