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e-CFR data is current as of August 7, 2020

Title 21Chapter ISubchapter HPart 866Subpart D → §866.3130

Title 21: Food and Drugs
Subpart D—Serological Reagents

§866.3130   Clostridium difficile toxin gene amplification assay.

(a) Identification. A Clostridium difficile toxin gene amplification assay is a device that consists of reagents for the amplification and detection of target sequences in Clostridium difficile toxin genes in fecal specimens from patients suspected of having Clostridium difficile infection (CDI). The detection of clostridial toxin genes, in conjunction with other laboratory tests, aids in the clinical laboratory diagnosis of CDI caused by Clostridium difficile.

(b) Classification. Class II (special controls). The special controls are set forth in FDA's guideline document entitled: “Class II Special Controls Guideline: Toxin Gene Amplification Assays for the Detection of Clostridium difficile; Guideline for Industry and Food and Drug Administration Staff.” See §866.1(e) for information on obtaining this document.

[80 FR 51939, Aug. 27, 2015]

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