Xpert Xpress Strep A
FDA 510(k) clearance K172126 · decided 2017-09-25
Clearance details
- K-number
- K172126
- Device name
- Xpert Xpress Strep A
- Applicant
- Cepheid
- Decision
- Substantially Equivalent
- Date received
- 2017-07-14
- Decision date
- 2017-09-25
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- PGX
- Device class
- 2
- Regulation number
- 866.2680
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
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| Accula Strep A Test (K201269) | Mesa Biotech, Inc. | 2020-11-09 |
| GenePOC Strep A (K183366) | Genepoc, Inc. | 2019-03-06 |
| Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit (K173653) | Alere Scarborough, Inc. | 2018-05-02 |
| Xpert Xpress Strep A (K173398) | Cepheid | 2018-04-26 |
| ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit (K172402) | Luminex Corporation | 2017-10-30 |
| Solana Strep Complete Assay (K162274) | Quidel Corporation | 2016-10-25 |
| Solana GAS Assay, Solana instrument (K150868) | Quidel Corporation | 2015-06-23 |
| ALERE I STREP A (K141757) | Alere Scarborough, Inc. | 2015-03-31 |
| Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack (K143651) | Focus Diagnostics, Inc. | 2015-03-18 |
| LIAT STREP A ASSAY (K141338) | Iquum, Inc. | 2014-11-04 |
| AMPLIVUE GAS ASSAY (K141173) | Quidel Corporation | 2014-07-24 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only recall (Z-0215-2024) | Cepheid | 2023-11-02 |
| Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD, recall (Z-0216-2024) | Cepheid | 2023-11-02 |