Xpert® SA Nasal Complete
FDA 510(k) K243070 · Cepheid®
510(k) numberK243070
Submission
- Device name
- Xpert® SA Nasal Complete
- Applicant
- Cepheid®
Sunnyvale, CA, US - Received
- September 27, 2024
- Decision date
- October 25, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NQX – System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1640
- Specialty
- Microbiology
A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of MRSA colonization status for the prevention and control of MRSA infections in healthcare settings.
Other 510(k)s with product code NQX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243625 | Xpert MRSA/SA SSTINQX · Special | Cepheid® | 12/18/2024SE |
| K191742 | ARIES MRSA AssayNQX · Traditional | Luminex Corporation | 09/25/2019SE |
| K190771 | Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System…NQX · Special | Cepheid | 04/25/2019SE |
| K162444 | Xpert MRSA NxGNQX · Traditional | Cepheid | 11/23/2016SE |
| K142721 | cobas MRSA/SA TestNQX · Traditional | Roche Molecular Systems, Inc. | 12/17/2014SE |
| K133605 | BD Max Mrsa XT, BD Max InstrumentNQX · Traditional | Geneohm Sciences Canada, Inc. | 12/20/2013SE |
| K132822 | BD Max Staphsr Assay, InstrumentNQX · Traditional | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 11/26/2013SE |
| K132468 | Mrsa/Sa Elite MGB, Elite MGB SoftwareNQX · Traditional | Elitechgroup Epoch Biosciences | 10/17/2013SE |
| K130894 | Xpert Mrsa/Sa Blood Culture Assay; Genexpert DX Systems (Gx-I, Gx-Ii, Gx-Iv, Gx-Xvi)…NQX · Traditional | Cepheid | 06/20/2013SE |
| K120138 | BD Max Mrsa Assay, BD Max InstrumentNQX · Traditional | Bd Diagnostics (Geneohm Sciences Canada, Inc) | 07/05/2012SE |
More from Bd Diagnostics (Geneohm Sciences Canada, Inc)
| 510(k) | Device | Decision |
|---|---|---|
| K261362 | Xpert Hemorrhagic FeverQVR · Dual Track | 08/07/2026SE |
| K261867 | Xpert Carba-RPOC · Special | 07/02/2026SE |
| K253653 | Xpert Hemorrhagic Fever · Traditional | 02/20/2026SE |
| K251721 | Xpert GI PanelPCH · Traditional | 01/16/2026SE |
| K250996 | Xpert Xpress CoV-2/Flu/RSV plusQOF · Special | 05/01/2025SE |
| K250995 | Xpert Xpress CoV-2/Flu/RSV plusQOF · Special | 05/01/2025SE |
| K243730 | Xpert C. difficile/EpiOZN · Traditional | 02/28/2025SE |
| K250218 | Xpert® FII & FVNPR · Special | 02/21/2025SE |
| K242109 | Xpert® Xpress CoV-2 plus (XPRS-COV2-10)QQX · Dual Track | 01/15/2025SE |
| K242071 | Xpert Xpress CoV-2/Flu/RSV plusQOF · Dual Track | 01/10/2025SE |
Questions and answers
When was Xpert® SA Nasal Complete cleared by the FDA?
Xpert® SA Nasal Complete (K243070) received a 510(k) decision of Substantially Equivalent on October 25, 2024, 28 days after the submission was received.
What is the product code of K243070?
The FDA product code is NQX – System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen, a Class II (moderate risk) device regulated under 21 CFR 866.1640.