Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack
FDA 510(k) K163085 · Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC
510(k) numberK163085
Submission
- Device name
- Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack
- Applicant
- Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC
Cypress, CA, US - Received
- November 3, 2016
- Decision date
- February 14, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OZN – C. Difficile Toxin Gene Amplification Assay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3130
- Specialty
- Microbiology
Amplification assay for the detection of c. Difficile toxin genes from stool specimens of symptomatic patients.
Other 510(k)s with product code OZN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260045 | cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas®…OZN · Traditional | Roche Molecular Systems, Inc. | 08/28/2026SE |
| K243730 | Xpert C. difficile/EpiOZN · Traditional | Cepheid® | 02/28/2025SE |
| K232092 | Great Basin Toxigenic C. difficile Direct Test (CDF2)OZN · Traditional | Vela Operations USA | 11/14/2023SE |
| K212427 | cobas Cdiff nucleic acid test for use on the cobas Liat SystemOZN · Special | Roche Molecular Systems, Inc. | 10/20/2021SE |
| K210385 | cobas Cdiff nucleic acid test for use on the cobas Liat SystemOZN · Special | Roche Molecular Systems, Inc. | 09/09/2021SE |
| K172569 | GenePOC CDiffOZN · Traditional | Genepoc, Inc. | 11/22/2017SE |
| K171770 | cobas Cdiff Nucleic acid test for use on the cobas Liat SystemOZN · Traditional | Roche Molecular Systems, Inc. | 09/12/2017SE |
| K171441 | ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES…OZN · Traditional | Luminex Corporation | 07/21/2017SE |
| K170491 | Solana C. difficile AssayOZN · Traditional | Quidel Corporation | 05/11/2017SE |
| K142422 | cobas Cdiff TestOZN · Traditional | Roche Molecular Systems, Inc. | 05/20/2015SE |
Questions and answers
When was Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack cleared by the FDA?
Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack (K163085) received a 510(k) decision of Substantially Equivalent on February 14, 2017, 103 days after the submission was received.
What is the product code of K163085?
The FDA product code is OZN – C. Difficile Toxin Gene Amplification Assay, a Class II (moderate risk) device regulated under 21 CFR 866.3130.