← Product Code [OZN](/submissions/MI/subpart-d%E2%80%94serological-reagents/OZN) · K123355 # AMPLIVUE C. DIFFICILE ASSAY (K123355) _Quidel Corporation · OZN · Dec 13, 2012 · Microbiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OZN/K123355 ## Device Facts - **Applicant:** Quidel Corporation - **Product Code:** [OZN](/submissions/MI/subpart-d%E2%80%94serological-reagents/OZN.md) - **Decision Date:** Dec 13, 2012 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.3130 - **Device Class:** Class 2 - **Review Panel:** Microbiology ## Indications for Use The AmpliVue™ C. difficile Assay is an in vitro diagnostic test for the direct, qualitative detection of the Clostridium difficile Toxin A gene (tcdA) in unformed stool specimens of patients suspected of having Clostridium difficile-associated disease (CDAD). The AmpliVue™ C. difficile Assay is intended for use as an aid in diagnosis of CDAD. The assay utilizes helicase-dependent amplification (HDA) for the amplification of a highly conserved fragment of the Toxin A gene sequence and a self-contained disposable amplicon device that allows for manual evaluation of assay results. ## Device Story Device performs qualitative detection of C. difficile Toxin A gene (tcdA) in unformed stool samples. Process: specimen collected via swab, diluted, and lysed via heat treatment. Lysed sample added to reaction tube containing lyophilized helicase-dependent amplification (HDA) reagents. HDA amplifies conserved tcdA fragment; process control DNA included to monitor inhibition and reagent integrity. Reaction tube transferred to single-use, disposable cassette. Cassette contains lateral flow DNA detection strip with anti-FITC and anti-DNP antibodies. Dual-labeled amplicons (biotinylated and probe-labeled) bind to strip; streptavidin-conjugated color particles enable visual detection of test (T2) and control (C) lines. Procedure takes ~75 minutes. Used in clinical settings by laboratory personnel. Output is visual presence/absence of colored lines in cassette window, aiding CDAD diagnosis. ## Clinical Evidence Method comparison study evaluated 835 specimens against Tissue Culture Cytotoxicity Assay. Results: 93.6% sensitivity (95% CI: 87.3-96.9%) and 94.1% specificity (95% CI: 92.1-95.6%). Discordant analysis showed 37/43 AmpliVue-positive/Cytotoxin-negative samples were positive by other FDA-cleared molecular tests. Reproducibility study across three sites showed 100% agreement for positive/negative controls and 80% agreement for high-negative samples. ## Technological Characteristics Isothermal helicase-dependent amplification (HDA). Single-use, disposable fluidic cassette with lateral flow DNA detection strip. Manual read. Reagents: lyophilized HDA mix, biotinylated primers, streptavidin-conjugated color particles. Targets tcdA gene. Process control included. No specialized instrumentation required. ## Regulatory 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. ## Special Controls In combination with the general controls of the FD&C Act, the Portrait Toxigenic C. difficile Assay is subject to the following special controls: 1. The special controls for the Clostridium difficile toxin gene amplification assay are contained in the guidance document: "Class II Special Controls Guidance Document: Toxin Gene Amplification Assays for the Detection of Clostridium difficile." *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. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} Decision Summary, k123355 This 510(k) was reviewed under OIR's Pilot Triage Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA. The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant's 510(k) summary for a summary of the information that supports this SE determination. --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OZN/K123355](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OZN/K123355) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com