ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit
FDA 510(k) K171441 · Luminex Corporation
510(k) numberK171441
Submission
- Device name
- ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit
- Applicant
- Luminex Corporation
Austin, TX, US - Received
- May 16, 2017
- Decision date
- July 21, 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 |
| K170491 | Solana C. difficile AssayOZN · Traditional | Quidel Corporation | 05/11/2017SE |
| K163085 | Simplexa C. difficile Direct; Simplexa C. difficile Positive Control PackOZN · Traditional | Focus Diagnostics, Inc.:Dba Diasorin Molecular… | 02/14/2017SE |
| K142422 | cobas Cdiff TestOZN · Traditional | Roche Molecular Systems, Inc. | 05/20/2015SE |
More from Roche Molecular Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253722 | LIAISON PLEX Gastrointestinal Flex AssayPCH · Traditional | 05/19/2026SE |
| K243490 | LIAISON PLEX Gram-Positive Blood Culture AssayPAM · Traditional | 06/06/2025SE |
| K243013 | LIAISON PLEX Gram-Negative Blood Culture AssayPEN · Traditional | 04/18/2025SE |
| K240627 | LIAISON PLEX Yeast Blood Culture AssayPEO · Traditional | 06/04/2024SE |
| K233410 | LIAISON PLEX Respiratory Flex AssayQOF · Traditional | 03/01/2024SE |
| K191742 | ARIES MRSA AssayNQX · Traditional | 09/25/2019SE |
| K172402 | ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File KitPGX · Traditional | 10/30/2017SE |
| K163626 | ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File KitOZZ · Traditional | 05/02/2017SE |
| K162772 | ARIES GBS AssayNJR · Traditional | 12/23/2016SE |
| K161220 | ARIES® Flu A/B & RSV AssayOCC · Traditional | 08/02/2016SE |
Questions and answers
When was ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit cleared by the FDA?
ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit (K171441) received a 510(k) decision of Substantially Equivalent on July 21, 2017, 66 days after the submission was received.
What is the product code of K171441?
The FDA product code is OZN – C. Difficile Toxin Gene Amplification Assay, a Class II (moderate risk) device regulated under 21 CFR 866.3130.