BD MAX CDIFF ASSAY, BD MAX INSTRUMENT

K130470 · Geneohm Sciences Canada, Inc. (Bd Diagnostics) · OZN · Apr 2, 2013 · Microbiology

Device Facts

• Record ID: K130470
• Device Name: BD MAX CDIFF ASSAY, BD MAX INSTRUMENT
• Applicant: Geneohm Sciences Canada, Inc. (Bd Diagnostics)
• Product Code: OZN · Microbiology
• Decision Date: Apr 2, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3130
• Device Class: Class 2

Indications for Use

The BD MAX™ Cdiff Assay performed on the BD MAX™ System is an automated in vitro diagnostic test for the direct, qualitative detection of the Clostridium difficile toxin B gene (tcdB) in human liquid or soft stool specimens from patients suspected of having C. difficile infection (CDI). The test. performed directly on the specimen, utilizes real-time polymerase chain reaction (PCR) for the amplification of C. difficile toxin B gene DNA and fluorogenic target-specific hybridization probes for the detection of the amplified DNA. The BD MAX ™ Cdiff Assay is intended to aid in the diagnosis of CDI.

Device Story

The BD MAX™ Cdiff Assay is an automated in vitro diagnostic test performed on the BD MAX™ System. It processes liquid or soft stool specimens to detect the C. difficile toxin B gene (tcdB). The system automates sample preparation, including cell lysis, DNA extraction, and concentration using magnetic beads. It then performs real-time PCR amplification and detection using fluorogenic target-specific hybridization probes. The system includes a Sample Processing Control (SPC) to monitor extraction, thermal cycling, and inhibition. Results are automatically interpreted by the system software as positive, negative, or unresolved. The assay is used in clinical laboratories to aid in the diagnosis of CDI, providing healthcare providers with rapid, automated results to inform clinical decision-making and patient management.

Clinical Evidence

A multi-site prospective study (6 sites) compared the BD MAX™ Cdiff Assay to a reference method (direct and enriched culture). Of 1819 compliant specimens, sensitivity was 87.7% (95% CI: 83.6%, 91.0%) and specificity was 96.8% (95% CI: 95.8%, 97.6%). Comparison to direct culture alone showed 96.5% positive percent agreement and 92.7% negative percent agreement. Additional comparison studies against two other FDA-cleared molecular assays showed high concordance (PPA 99.1%/95.5% and NPA 97.4%/98.8%).

Technological Characteristics

Automated in vitro diagnostic test using real-time PCR. Components include microfluidic cartridges, master mixes, reagent strips, and sample buffer tubes. Sensing principle: hydrolysis (TaqMan®) probes with fluorogenic detection in two optical channels. Connectivity: integrated with BD MAX™ System. Software: automated interpretation of amplification curves. Sterilization: not specified.

Indications for Use

Indicated for direct, qualitative detection of Clostridium difficile toxin B gene (tcdB) in liquid or soft stool specimens from patients suspected of having C. difficile infection (CDI). For prescription use.

Regulatory Classification

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)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) #: K130470

This 510(k) was reviewed under OIR’s Triage-Quick Review 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.