NUCLISENS EASYQ MRSA; NUCLISENS EASYQ ANALYZER; NUCLISENS EASYQ INCUBATOR (110 VOLT); NUCLISENS DIRECTOR V.2.6
FDA 510(k) clearance K102740 · decided 2011-05-20
Clearance details
- K-number
- K102740
- Device name
- NUCLISENS EASYQ MRSA; NUCLISENS EASYQ ANALYZER; NUCLISENS EASYQ INCUBATOR (110 VOLT); NUCLISENS DIRECTOR V.2.6
- Applicant
- bioMerieux, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-09-22
- Decision date
- 2011-05-20
- Days to decision
- 240 days
- Clearance type
- Traditional
- Product code
- NQX
- Device class
- 2
- Regulation number
- 866.1640
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Durham, NC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Xpert MRSA/SA SSTI (K243625) | Cepheid® | 2024-12-18 |
| Xpert® SA Nasal Complete (K243070) | Cepheid® | 2024-10-25 |
| ARIES MRSA Assay (K191742) | Luminex Corporation | 2019-09-25 |
| Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System (K190771) | Cepheid | 2019-04-25 |
| Xpert MRSA NxG (K162444) | Cepheid | 2016-11-23 |
| cobas MRSA/SA Test (K142721) | Roche Molecular Systems, Inc. | 2014-12-17 |
| BD MAX MRSA XT, BD MAX INSTRUMENT (K133605) | Geneohm Sciences Canada, Inc. | 2013-12-20 |
| BD MAX STAPHSR ASSAY, INSTRUMENT (K132822) | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2013-11-26 |
| MRSA/SA ELITE MGB, ELITE MGB SOFTWARE (K132468) | Elitechgroup Epoch Biosciences | 2013-10-17 |
| XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI); GENEXPERT INFINITY-48 SYSTEM; GENE (K130894) | Cepheid | 2013-06-20 |
| BD MAX MRSA ASSAY, BD MAX INSTRUMENT (K120138) | Bd Diagnostics (Geneohm Sciences Canada, Inc) | 2012-07-05 |
| MRSA/SA ELITE MGB (K112937) | Elitech | 2012-06-01 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| THXID-BRAF (P120014/S012) | bioMerieux, Inc. | 2021-12-20 |
| THxID-BRAF kit (P120014/S011) | bioMerieux, Inc. | 2021-03-10 |
| THxID-BRAF assay kit (P120014/S010) | bioMerieux, Inc. | 2020-02-26 |
| THxID BRAF assay kit (P120014/S009) | bioMerieux, Inc. | 2019-08-26 |
| THxID BRAF assay kit (P120014/S008) | bioMerieux, Inc. | 2018-06-27 |
| THxID-BRAF kit (P120014/S007) | bioMerieux, Inc. | 2016-11-22 |
| VIDAS TOTAL PSA (P040008/S013) | bioMerieux, Inc. | 2016-05-31 |
| THXID-BRAF KIT (P120014/S006) | bioMerieux, Inc. | 2016-04-05 |