FDA product code JMG: Radioimmunoassay (Two-Site Solid Phase), Ferritin
JMG is the FDA product code for radioimmunoassay (two-site solid phase), ferritin. It is a Class II device, regulated under 21 CFR 866.5340 and reviewed by the Clinical Chemistry panel. FDA has cleared 24 510(k) submissions under JMG, 1 in the last five years, from 19 different applicants. The average 510(k) review took 64 days (median 50); 90 days on average over the last three years. FDA has posted 5 recalls for JMG devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay (Two-Site Solid Phase), Ferritin |
| Device class | Class II |
| Regulation | 21 CFR 866.5340 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for JMG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 90 |
Compare with all 510(k) review times · Search every JMG clearance
Top JMG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Beckman Coulter, Inc. | 2 | 2024-03-20 |
| Boehringer Mannheim Corp. | 2 | 1997-07-30 |
| Diagnostic Products Corp. | 2 | 1993-01-13 |
| Corning Medical & Scientific | 2 | 1984-03-30 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 2 | 1980-01-11 |
14 more applicants have JMG clearances. See the full list in Caduvo.
Most recent JMG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K234052 | Beckman Coulter, Inc. | Access Ferritin | 2024-03-20 | 90 |
| K052082 | Beckman Coulter, Inc. | FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020 | 2005-08-19 | 17 |
| K964282 | Boehringer Mannheim Corp. | TINA-QUANT FERRITIN ASSAY | 1997-07-30 | 275 |
| K971833 | Boehringer Mannheim Corp. | ELECSYS FERRITIN | 1997-06-02 | 14 |
| K963498 | Dade Chemistry Systems, Inc. | FERR FLEX REAGENT CARTRIDGE | 1997-01-24 | 143 |
Recalls for JMG devices
5 product recalls in 5 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2019 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code JMG?
JMG is the FDA product code for radioimmunoassay (two-site solid phase), ferritin. It is a Class II device, regulated under 21 CFR 866.5340 and reviewed by the Clinical Chemistry panel.
What device class is JMG?
Class II, regulation 21 CFR 866.5340. Typical premarket route: 510(k).
How long does a 510(k) take for product code JMG?
Across 24 cleared submissions the average was 64 days from receipt to decision (median 50).
Which companies have the most JMG clearances?
Beckman Coulter, Inc. (2); Boehringer Mannheim Corp. (2); Diagnostic Products Corp. (2); Corning Medical & Scientific (2); Bd Becton Dickinson Vacutainer Systems Preanalytic (2).
Have JMG devices been recalled?
Yes: 5 product recalls across 5 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code JMG
- Run a recall and safety report across every JMG manufacturer
- Watch product code JMG 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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