FDA product code MMI: Immunoassay Method, Troponin Subunit
MMI is the FDA product code for immunoassay method, troponin subunit. It is a Class II device, regulated under 21 CFR 862.1215 and reviewed by the Clinical Chemistry panel. FDA has cleared 95 510(k) submissions under MMI, 11 in the last five years, from 39 different applicants. The average 510(k) review took 140 days (median 85); 220 days on average over the last three years. FDA has posted 56 recalls for MMI devices, 7 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Immunoassay Method, Troponin Subunit |
| Device class | Class II |
| Regulation | 21 CFR 862.1215 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
510(k) clearances per year for MMI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 93 |
| 2018 | 4 | 348 |
| 2019 | 3 | 117 |
| 2021 | 1 | 477 |
| 2022 | 1 | 625 |
| 2023 | 3 | 250 |
| 2024 | 2 | 176 |
| 2025 | 4 | 222 |
| 2026 | 1 | 262 |
Compare with all 510(k) review times · Search every MMI clearance
Top MMI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Beckman Coulter, Inc. | 10 | 2025-08-01 |
| Dade Behring, Inc. | 7 | 2007-03-19 |
| Boehringer Mannheim Corp. | 6 | 1998-12-08 |
| Siemens Healthcare Diagnostics, Inc. | 5 | 2024-07-25 |
| Roche Diagnostics | 4 | 2021-09-21 |
34 more applicants have MMI clearances. See the full list in Caduvo.
Most recent MMI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253051 | Abbott Point of Care, Inc. | i-STAT hs-TnI cartridge with the i-STAT Alinity System | 2026-06-11 | 262 |
| K252393 | Ortho-Clinical Diagnostics, Inc. | VITROS Immunodiagnostic Products hs Troponin I Reagent Pack | 2025-10-29 | 90 |
| K243483 | Beckman Coulter, Inc. | Access hsTnI | 2025-08-01 | 266 |
| K242870 | Beckman Coulter, Inc. | Access hsTnI | 2025-06-16 | 266 |
| K240984 | Abbott Point of Care, Inc. | i-STAT hs-TnI cartridge with the i-STAT 1 System | 2025-01-03 | 268 |
Recalls for MMI devices
56 product recalls in 49 recall events; 7 initiated in the last five years and 8 still open. Most recent: 2024-11-18.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 3 |
| 2019 | 2 |
| 2020 | 2 |
| 2021 | 3 |
| 2022 | 3 |
| 2023 | 3 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code MMI?
MMI is the FDA product code for immunoassay method, troponin subunit. It is a Class II device, regulated under 21 CFR 862.1215 and reviewed by the Clinical Chemistry panel.
What device class is MMI?
Class II, regulation 21 CFR 862.1215. Typical premarket route: 510(k).
How long does a 510(k) take for product code MMI?
Across 95 cleared submissions the average was 140 days from receipt to decision (median 85).
Which companies have the most MMI clearances?
Beckman Coulter, Inc. (10); Dade Behring, Inc. (7); Boehringer Mannheim Corp. (6); Siemens Healthcare Diagnostics, Inc. (5); Roche Diagnostics (4).
Have MMI devices been recalled?
Yes: 56 product recalls across 49 recall events; the most recent began 2024-11-18.
Next steps
- Run an FDA pathway report with predicate devices for product code MMI
- Run a recall and safety report across every MMI manufacturer
- Watch product code MMI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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