Anti-HCV Next
FDA 510(k) K252424 · Abbott Laboratories
510(k) numberK252424
Submission
- Device name
- Anti-HCV Next
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- August 1, 2025
- Decision date
- April 28, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MZO – Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3169
- Specialty
- Microbiology
Other 510(k)s with product code MZO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K221693 | Elecsys Anti-HCV II (08837031190)MZO · Traditional | Roche Diagnostics | 01/04/2023SE |
More from Roche Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K243500 | ARCHITECT iGentamicinLCD · Special | 07/09/2025SE |
| K243168 | Alinity i Rubella IgGLFX · Traditional | 06/20/2025SE |
| K243283 | Alinity h-series SystemGKZ · Traditional | 02/20/2025SE |
| K233932 | Alinity i Toxo IgMLGD · Traditional | 08/30/2024SE |
| K232669 | TbiQAT · Special | 09/29/2023SE |
| K222850 | HAVAb IgG IILOL · Traditional | 08/10/2023SE |
| K220031 | Alinity h-series SystemGKZ · Traditional | 08/04/2023SE |
| K220282 | i-STAT PTplus Cartridge with the i-STAT 1 SystemGJS · Traditional | 07/14/2023SE |
| K230937 | Alinity i Total ß-hCG Reagent Kit, GLP systems TrackDHA · Traditional | 06/05/2023SE |
| K230790 | Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample…DHA · Traditional | 05/19/2023SE |
Questions and answers
When was Anti-HCV Next cleared by the FDA?
Anti-HCV Next (K252424) received a 510(k) decision of Substantially Equivalent on April 28, 2026, 270 days after the submission was received.
What is the product code of K252424?
The FDA product code is MZO – Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus, a Class II (moderate risk) device regulated under 21 CFR 866.3169.