510(k) K091409
- Device
- LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727
- Applicant
- ROCHE MOLECULAR SYSTEMS, INC.
- 510(k) number
- K091409
- Product code
- NQX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-07-06
- Date received
- 2009-05-13
- Regulation
- 866.1640
- Classification name
- System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LARRY PIETRELLI
- Address
- 4300 Hacienda Dr. Pleasanton CA US 94588 94588
FDA Registration Numbers#
- 3003030793
- 2243471
- 3004141078
- 9610126
- 2024800
- 1550222
- 3007420875
- 3003540236
- 1119779
- 3016838963
- 3004530258
- 3003795116
Source Documents#
Other 510(k) Records For Product Code NQX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243625 | Xpert MRSA/SA SSTI | Cepheid® | 2024-12-18 |
| K243070 | Xpert® SA Nasal Complete | Cepheid® | 2024-10-25 |
| K191742 | ARIES MRSA Assay | Luminex Corporation | 2019-09-25 |
| K190771 | Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System | Cepheid | 2019-04-25 |
| K162444 | Xpert MRSA NxG | Cepheid | 2016-11-23 |
| K142721 | cobas MRSA/SA Test | Roche Molecular Systems, Inc. | 2014-12-17 |
| K133605 | BD MAX MRSA XT, BD MAX INSTRUMENT | Geneohm Sciences Canada, Inc. | 2013-12-20 |
| K132822 | BD MAX STAPHSR ASSAY, INSTRUMENT | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2013-11-26 |
| K132468 | MRSA/SA ELITE MGB, ELITE MGB SOFTWARE | Elitechgroup Epoch Biosciences | 2013-10-17 |
| K130894 | XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI); GENEXPERT INFINITY-48 SYSTEM; GENE | Cepheid | 2013-06-20 |
| K120138 | BD MAX MRSA ASSAY, BD MAX INSTRUMENT | Bd Diagnostics (Geneohm Sciences Canada, Inc) | 2012-07-05 |
| K112937 | MRSA/SA ELITE MGB | Elitech | 2012-06-01 |
| K112424 | VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S) | Nanosphere, Inc. | 2011-12-16 |
| K102740 | NUCLISENS EASYQ MRSA; NUCLISENS EASYQ ANALYZER; NUCLISENS EASYQ INCUBATOR (110 VOLT); NUCLISENS DIRECTOR V.2.6 | bioMerieux, Inc. | 2011-05-20 |
| K101879 | XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10 | Cepheid | 2010-07-28 |
Legacy Summary#
summary
FDA Review#
Decision Summary