Mrsa/Sa Elite MGB
FDA 510(k) K112937 · Elitech
510(k) numberK112937
Submission
- Device name
- Mrsa/Sa Elite MGB
- Applicant
- Elitech
Bothell, WA, US - Received
- October 3, 2011
- Decision date
- June 1, 2012
- 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
Questions and answers
When was Mrsa/Sa Elite MGB cleared by the FDA?
Mrsa/Sa Elite MGB (K112937) received a 510(k) decision of Substantially Equivalent on June 1, 2012, 242 days after the submission was received.
What is the product code of K112937?
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.