Ferritin RIA Kit
by Diagnostic Products Corp. 510(k)
Active
510(k) K801580
Overview
The Ferritin RIA Kit is an in vitro diagnostic device used for the quantitative measurement of ferritin in serum or plasma via radioimmunoassay (RIA) technology. Ferritin is a protein that stores iron and serves as a biomarker for iron stores, often assessed in diagnosing iron deficiency, anemia, or hemochromatosis. This kit comprises antigen, antiserum, controls, and reagents necessary for the assay process, enabling precise detection of ferritin levels in clinical samples.
This kit is supplied as a single-use diagnostic reagent set, requiring no sterilization beyond manufacturer-provided packaging. It is intended for use in clinical laboratories under appropriate radiation safety protocols due to the inclusion of radioactive iodine-125 (¹²⁵I). The device is classified as a Class 2 medical device under FDA regulation 866.5340 and holds a 510(k) clearance (K801580) with a Substantially Equivalent (SESE) determination. Storage conditions and handling must comply with radioactive material regulations, and the kit is not intended for MRI use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK801580 | Date13 Aug 1980 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DBF
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5340
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Diagnostic Products Corp.
Questions
What is the Ferritin RIA Kit used for?
The Ferritin RIA Kit is designed for the quantitative measurement of ferritin levels in serum or plasma samples. Ferritin is a protein that stores iron and serves as a key biomarker for diagnosing conditions like iron deficiency, anemia, or hemochromatosis. By detecting ferritin concentrations, clinicians can assess iron stores and guide treatment decisions.
How is the Ferritin RIA Kit supplied and intended for use?
This kit is supplied as a single-use diagnostic reagent set, containing antigen, antiserum, controls, and reagents required for the radioimmunoassay (RIA) process. It is intended exclusively for use in clinical laboratories under proper radiation safety protocols due to the presence of radioactive iodine-125 (¹²⁵I). The kit is not meant for sterilization beyond the manufacturer’s sealed packaging.
Does the Ferritin RIA Kit require special handling or storage?
Yes, the kit must be handled and stored in compliance with radioactive material regulations because it contains radioactive iodine-125. Storage conditions should follow manufacturer guidelines to ensure safety and integrity. Additionally, it is not intended for use in MRI environments, as radioactive materials can interfere with magnetic resonance imaging.
Is the Ferritin RIA Kit reusable or single-use?
The Ferritin RIA Kit is explicitly designed for single-use only. Each kit is intended for one assay procedure, and reuse is not recommended or supported by the manufacturer. This ensures accuracy and safety, particularly given the radioactive components involved.
What regulatory classification does the Ferritin RIA Kit hold?
The Ferritin RIA Kit is classified as a Class 2 medical device under FDA regulation 866.5340. It holds a 510(k) clearance (K801580) with a Substantially Equivalent (SESE) determination, indicating it meets FDA standards for safety and effectiveness in its intended use for ferritin measurement.