FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Xpert Xpress CoV-2/Flu/RSV plus
K Number: K250995
·
Decision May 1, 2025
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
32
Applicant Total
10
Review Days
30
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Basic Information
- Device Name
- Xpert Xpress CoV-2/Flu/RSV plus
- K Number
- K250995
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 866.3981
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cepheid®
- Date Received
- April 1, 2025
- Decision Date
- May 1, 2025
- Product Code
- QOF
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | FDA class 2 | Microbiology |
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Other Clearances by Cepheid®
| K Number | Device Name | ||
|---|---|---|---|
| K250996 | Xpert Xpress CoV-2/Flu/RSV plus | May 1, 2025 | Substantially Equivalent |
| K243730 | Xpert C. difficile/Epi | Feb 28, 2025 | Substantially Equivalent |
| K242109 | Xpert® Xpress CoV-2 plus (XPRS-COV2-10) | Jan 15, 2025 | Substantially Equivalent |
| K243625 | Xpert MRSA/SA SSTI | Dec 18, 2024 | Substantially Equivalent |
| K243405 | Xpert vanA | Nov 21, 2024 | Substantially Equivalent |
| K243070 | Xpert® SA Nasal Complete | Oct 25, 2024 | Substantially Equivalent |
| K230440 | Xpert® Xpress CoV-2 plus | Oct 13, 2023 | Substantially Equivalent |
| K231481 | Xpert Xpress CoV-2/Flu/RSV plus | Aug 17, 2023 | Substantially Equivalent |
| K223046 | Xpert® FII & FV | Feb 15, 2023 | Substantially Equivalent |