Aia-Pack Ctni 2ND-GEN Assay
FDA 510(k) K012820 · Tosoh Medics, Inc.
510(k) numberK012820
Submission
- Device name
- Aia-Pack Ctni 2ND-GEN Assay
- Applicant
- Tosoh Medics, Inc.
South San Francisco, CA, US - Received
- August 23, 2001
- Decision date
- December 14, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
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| K023091 | ST Aia-Pack Testosterone AssayCDZ · Traditional | 12/17/2002SE |
| K023891 | ST Aia-Pack Ca 125 Enzyme ImmunoassayLTK · Special | 12/06/2002SE |
| K020489 | G7 Automated HPLC Analyzer, Beta-Thalassemia ModeJPD · Traditional | 05/14/2002SE |
| K011434 | G7 Automated HPLC AnalyzerLCP · Traditional | 09/18/2001SE |
| K010796 | Aia-Pack Brca, ST Aia Pack BrcaMOI · Traditional | 08/16/2001SE |
| K992365 | Aia-Pack Folate AssayCGN · Traditional | 08/10/1999SE |
| K990431 | Aia-Pack Ca 125LTK · Traditional | 06/03/1999SE |
| K991252 | Aia-Pack FT3 AssayCDP · Traditional | 05/11/1999SE |
Questions and answers
When was Aia-Pack Ctni 2ND-GEN Assay cleared by the FDA?
Aia-Pack Ctni 2ND-GEN Assay (K012820) received a 510(k) decision of Substantially Equivalent on December 14, 2001, 113 days after the submission was received.
What is the product code of K012820?
The FDA product code is MMI – Immunoassay Method, Troponin Subunit, a Class II (moderate risk) device regulated under 21 CFR 862.1215.