BD Geneohm Mrsa Acp Assay
FDA 510(k) K093346 · Bd Diagnostics (Geneohm Sciences, Inc.)
510(k) numberK093346
Submission
- Device name
- BD Geneohm Mrsa Acp Assay
- Applicant
- Bd Diagnostics (Geneohm Sciences, Inc.)
San Diego, CA, US - Received
- October 26, 2009
- Decision date
- December 15, 2009
- 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.
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| 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 |
More from Cepheid
| 510(k) | Device | Decision |
|---|---|---|
| K081920 | BD Geneohm Cdiff AssayLLH · Traditional | 12/19/2008SE |
Questions and answers
When was BD Geneohm Mrsa Acp Assay cleared by the FDA?
BD Geneohm Mrsa Acp Assay (K093346) received a 510(k) decision of Substantially Equivalent on December 15, 2009, 50 days after the submission was received.
What is the product code of K093346?
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.