i-STAT hs-TnI cartridge with the i-STAT Alinity System— 510(k) K253051
Substantially EquivalentAbbott Point of Care, Inc.
FDA 510(k) clearance K253051 for i-STAT hs-TnI cartridge with the i-STAT Alinity System, Substantially Equivalent on 2026-06-11. Applicant: Abbott Point of Care, Inc.. Device class: 2.
Summary
Abbott Point of Care's clearance is for the i-STAT hs-TnI cartridge with the i-STAT Alinity System, filed under MMI, troponin subunit immunoassay methods. The record doesn't describe the cartridge beyond its name and the code name.
Class II, 21 CFR 862.1215. Clinical Chemistry is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Abbott Point of Care filed from Princeton, New Jersey. Review took 262 calendar days (September 22, 2025 to June 11, 2026).
Clearance details
- Applicant
- Abbott Point of Care, Inc.
- Product code
- Product code MMI
- Device class
- Class 2
- Regulation
- 21 CFR 862.1215
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Princeton, NJ, US
Recent devices under product code MMI
view allMore clearances from Abbott Point of Care, Inc.
view allAdverse events under product code MMI
product code MMI- Injury
- 172
- Malfunction
- 3,762
- Total
- 3,934
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.