Instant-View Troponin I Test
FDA 510(k) K042227 · Alfa Scientific Designs, Inc.
510(k) numberK042227
Submission
- Device name
- Instant-View Troponin I Test
- Applicant
- Alfa Scientific Designs, Inc.
Poway, CA, US - Received
- August 17, 2004
- Decision date
- November 19, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MMI – Immunoassay Method, Troponin Subunit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1215
- Specialty
- Clinical Chemistry
Other 510(k)s with product code MMI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253051 | i-STAT hs-TnI cartridge with the i-STAT Alinity SystemMMI · Traditional | Abbott Point of Care, Inc. | 06/11/2026SE |
| K252393 | VITROS Immunodiagnostic Products hs Troponin I Reagent PackMMI · Traditional | Ortho-Clinical Diagnostics, Inc. | 10/29/2025SE |
| K243483 | Access hsTnIMMI · Traditional | Beckman Coulter, Inc. | 08/01/2025SE |
| K242870 | Access hsTnIMMI · Traditional | Beckman Coulter, Inc. | 06/16/2025SE |
| K240984 | i-STAT hs-TnI cartridge with the i-STAT 1 SystemMMI · Traditional | Abbott Point of Care, Inc. | 01/03/2025SE |
| K241165 | Atellica® IM High-Sensitivity Troponin I (TnIH)MMI · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/25/2024SE |
| K231974 | PATHFAST®hs-cTnI-IIMMI · Traditional | Phc Corporation | 03/20/2024SE |
| K222881 | Access hsTnIMMI · Traditional | Beckman Coulter, Inc. | 12/18/2023SE |
| K230648 | Access hsTnIMMI · Traditional | Beckman Coulter, Inc. | 12/04/2023SE |
| K230994 | Alinity i STAT High Sensitivity Troponin-IMMI · Special | Abbott Laboratories Diagnostics Division | 05/04/2023SE |
More from Abbott Laboratories Diagnostics Division
| 510(k) | Device | Decision |
|---|---|---|
| K173303 | INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW…DKZ · Traditional | 02/23/2018SE |
| K173212 | Instant-view-PLUS immunochemical Fecal Occult Blood TestKHE · Traditional | 02/15/2018SE |
| K152122 | Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test…DKZ · Traditional | 06/24/2016SE |
| K131645 | Instant-View Multi-Drug of Abuse Urine Test (Cup, Panel Cassette)DKZ · Abbreviated | 10/07/2013SE |
| K100051 | Instant-View Milti-Drug of Abuse Urine Test (Panel, Cup), Instant-Verdict Multi-Drug of…DJG · Abbreviated | 07/06/2010SE |
| K070660 | Instant-View Fecal Occult Blood (Fob) Rapid TestKHE · Traditional | 06/21/2007SE |
| K063545 | Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine Test(Cassette…DJG · Abbreviated | 05/07/2007SE |
| K060527 | Instant-View Bup/Nbup Urine Test. Instant-Verdict Bup/Nbup Urine Test…DJG · Abbreviated | 07/25/2006SE |
| K024360 | Instant-View H. Pylori One Step Rapid TestLYR · Traditional | 06/10/2003SE |
| K022693 | Instant-View Tca Urine TestMLK · Abbreviated | 12/09/2002SE |
Questions and answers
When was Instant-View Troponin I Test cleared by the FDA?
Instant-View Troponin I Test (K042227) received a 510(k) decision of Substantially Equivalent on November 19, 2004, 94 days after the submission was received.
What is the product code of K042227?
The FDA product code is MMI – Immunoassay Method, Troponin Subunit, a Class II (moderate risk) device regulated under 21 CFR 862.1215.