FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80
K Number: K143302
·
Decision Feb 12, 2015
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
1
Applicant Total
50
Review Days
87
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80
- K Number
- K143302
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3373
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cepheid
- Date Received
- November 17, 2014
- Decision Date
- February 12, 2015
- Product Code
- PEU
- 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 |
|---|---|---|---|
| PEU | System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PEU), ordered by most recent decision date.
View allOther Clearances by Cepheid
| K Number | Device Name | ||
|---|---|---|---|
| K253653 | Xpert Hemorrhagic Fever | Feb 20, 2026 | Substantially Equivalent |
| K251721 | Xpert GI Panel | Jan 16, 2026 | Substantially Equivalent |
| K250218 | Xpert® FII & FV | Feb 21, 2025 | Substantially Equivalent |
| K242071 | Xpert Xpress CoV-2/Flu/RSV plus | Jan 10, 2025 | Substantially Equivalent |
| DEN240016 | Xpert HCV; GeneXpert Xpress System | Jun 27, 2024 | Unknown |
| K231381 | Xpert Xpress MVP; GeneXpert Xpress System | Oct 19, 2023 | Substantially Equivalent |
| K222638 | Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems | Sep 27, 2023 | Substantially Equivalent |
| K221160 | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System | Jun 7, 2022 | Substantially Equivalent |
| K203429 | Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System | May 9, 2022 | Substantially Equivalent |
| K212213 | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System | Feb 9, 2022 | Substantially Equivalent |