510(k) K163085
- Device
- Simplexa C. Difficile Direct; Simplexa C. Difficile Positive Control Pack
- Applicant
- Focus Diagnostics, Inc.: DBA DiaSorin Molecular LLC
- 510(k) number
- K163085
- Product code
- OZN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-02-14
- Date received
- 2016-11-03
- Regulation
- 866.3130
- Classification name
- C. Difficile Toxin Gene Amplification Assay
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Irene M. Guzman
- Address
- 11331 Valley View St. Cypress CA US 90630 90630
FDA Registration Numbers#
- 2243471
- 3004141078
- 9610126
- 3007420875
- 3012494290
- 3012918440
- 1524213
- 3006028115
- 1528450
- 1119779
- 2023365
- 3004013603
- 3003795116
Source Documents#
Other 510(k) Records For Product Code OZN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243730 | Xpert C. difficile/Epi | Cepheid® | 2025-02-28 |
| K232092 | Great Basin Toxigenic C. difficile Direct Test (CDF2) | Vela Operations USA | 2023-11-14 |
| K212427 | cobas Cdiff nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. | 2021-10-20 |
| K210385 | cobas Cdiff nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. | 2021-09-09 |
| K172569 | GenePOC CDiff | Genepoc, Inc. | 2017-11-22 |
| K171770 | cobas Cdiff Nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. | 2017-09-12 |
| K171441 | ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit | Luminex Corporation | 2017-07-21 |
| K170491 | Solana C. difficile Assay | Quidel Corporation | 2017-05-11 |
| K142422 | cobas Cdiff Test | Roche Molecular Systems, Inc. | 2015-05-20 |
| K133936 | ARTUS C. DIFFICILE QS-RGQ MDX KIT | QIAGEN GmbH | 2014-04-04 |
| K132726 | ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM | Primeradx | 2013-11-29 |
| K132235 | IMDX C.DIFFICILE FOR ABBOTT M2000 | Intelligent Medical Devices, Inc. | 2013-10-11 |
| K130470 | BD MAX CDIFF ASSAY, BD MAX INSTRUMENT | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2013-04-02 |
| K123998 | QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY | Quidel Corp. | 2013-03-08 |
| K123355 | AMPLIVUE C. DIFFICILE ASSAY | Quidel Corporation | 2012-12-13 |
Legacy Summary#
summary
FDA Review#
Decision Summary