FDA product code DIE: Heavy Metals Control Materials
DIE is the FDA product code for heavy metals control materials. It is a Class I device, regulated under 21 CFR 862.3280 and reviewed by the Clinical Toxicology panel. FDA has cleared 5 510(k) submissions under DIE, from 3 different applicants. The average 510(k) review took 92 days (median 56).
Classification
| Field | Value |
|---|---|
| Device name | Heavy Metals Control Materials |
| Device class | Class I |
| Regulation | 21 CFR 862.3280 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DIE clearance
Top DIE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bio-Rad | 3 | 2002-04-22 |
| Actio, Inc. | 1 | 1989-04-10 |
| Shape Products Co. | 1 | 1986-11-24 |
Most recent DIE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K020610 | Bio-Rad | LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529 | 2002-04-22 | 56 |
| K990928 | Bio-Rad | LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405 | 1999-04-16 | 28 |
| K891691 | Bio-Rad | LYPHOCHEK URINE METALS CONTROL, LEVELS I AND II | 1989-12-19 | 272 |
| K890721 | Actio, Inc. | SHAPE-ACTIO METAL TOXICOLOGY CONTROL | 1989-04-10 | 56 |
| K863915 | Shape Products Co. | SHAPE-ACTIO METAL TOXICOLOGY CONTROL | 1986-11-24 | 47 |
Recalls for DIE devices
openFDA lists no recalls for product code DIE.
Frequently asked questions
What is FDA product code DIE?
DIE is the FDA product code for heavy metals control materials. It is a Class I device, regulated under 21 CFR 862.3280 and reviewed by the Clinical Toxicology panel.
What device class is DIE?
Class I, regulation 21 CFR 862.3280. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DIE?
Across 5 cleared submissions the average was 92 days from receipt to decision (median 56).
Which companies have the most DIE clearances?
Bio-Rad (3); Actio, Inc. (1); Shape Products Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DIE
- Run a recall and safety report across every DIE manufacturer
- Watch product code DIE 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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