DIE · Heavy Metals Control Materials
Clinical Toxicology · 21 CFR 862.3280 · Class 1
Overview
| Product Code | DIE |
|---|---|
| Device Name | Heavy Metals Control Materials |
| Regulation | 21 CFR 862.3280 |
| Device Class | Class 1 |
| Review Panel | Clinical Toxicology |
Identification
A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K020610 | LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529 | Bio-Rad | Apr 22, 2002 | SESE |
| K990928 | LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405 | Bio-Rad | Apr 16, 1999 | SESE |
| K891691 | LYPHOCHEK URINE METALS CONTROL, LEVELS I AND II | Bio-Rad | Dec 19, 1989 | SESE |
| K890721 | SHAPE-ACTIO METAL TOXICOLOGY CONTROL | Actio, Inc. | Apr 10, 1989 | SESE |
| K863915 | SHAPE-ACTIO METAL TOXICOLOGY CONTROL | Shape Products Co. | Nov 24, 1986 | SESE |
Top Applicants
- Bio-Rad — 3 clearances
- Actio, Inc. — 1 clearance
- Shape Products Co. — 1 clearance
