510(k) K243730
K243730 is an FDA 510(k) premarket notification submitted by Cepheid® for the device "Xpert C. difficile/Epi". The FDA issued a decision of Substantially Equivalent on February 28, 2025. The device falls under product code OZN (C. Difficile Toxin Gene Amplification Assay), a Class II device regulated under 21 CFR 866.3130. Cepheid® has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 2025
- Date Received
- December 3, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- C. Difficile Toxin Gene Amplification Assay
- Device Class
- Class II
- Regulation Number
- 866.3130
- Review Panel
- MI
- Submission Type
Amplification assay for the detection of c. Difficile toxin genes from stool specimens of symptomatic patients.