21 CFR § 866.3130 - Clostridium difficile toxin gene amplification assay.

---
identifier: "/us/cfr/t21/s866.3130"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 866.3130 - Clostridium difficile toxin gene amplification assay."
title_number: 21
title_name: "Food and Drugs"
section_number: "866.3130"
section_name: "Clostridium difficile toxin gene amplification assay."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "866"
part_name: "IMMUNOLOGY AND MICROBIOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "47 FR 50823, Nov. 9, 1982, unless otherwise noted."
cfr_part: "866"
---


# 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]