Xpert MRSA NxG
FDA 510(k) K162444 · Cepheid
510(k) numberK162444
Submission
- Device name
- Xpert MRSA NxG
- Applicant
- Cepheid
Sunnyvale, CA, US - Received
- August 31, 2016
- Decision date
- November 23, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
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|---|---|---|---|
| K243625 | Xpert MRSA/SA SSTINQX · Special | Cepheid® | 12/18/2024SE |
| K243070 | Xpert® SA Nasal CompleteNQX · Special | Cepheid® | 10/25/2024SE |
| 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 |
| 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 |
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| 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 MRSA NxG cleared by the FDA?
Xpert MRSA NxG (K162444) received a 510(k) decision of Substantially Equivalent on November 23, 2016, 84 days after the submission was received.
What is the product code of K162444?
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.