Vista Ferritin Assay
by Syva Co. 510(k)
Active
510(k) K931576
Overview
The Vista Ferritin Assay is an in vitro diagnostic device classified as a ferritin antigen assay, designed to quantitatively measure ferritin levels in human serum or plasma. Ferritin is a protein that stores iron and serves as a biomarker for iron stores, often used in the diagnosis and monitoring of conditions such as iron deficiency, anemia, and hemochromatosis. This assay employs immunoassay technology to detect and quantify ferritin concentrations accurately within clinical samples.
The Vista Ferritin Assay is supplied as a reagent kit for use with the Syva Vista Immunoassay System, a semi-automated immunoassay analyzer. It is intended for single-use in clinical laboratory settings and requires no special storage conditions beyond refrigeration (2–8°C) until use. The device is regulated under FDA 510(k) clearance (K931576) as a Class II device under product code DBF, with a decision of Substantially Equivalent issued in 1993. No MRI safety or reusable components are indicated in the specifications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK931576 | Date5 Aug 1993 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 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 Syva Co.
Questions
What clinical conditions is the Vista Ferritin Assay designed to help diagnose or monitor?
The Vista Ferritin Assay measures ferritin levels in human serum or plasma to assess iron stores. Ferritin serves as a biomarker for diagnosing and monitoring conditions like iron deficiency, anemia, and hemochromatosis, where abnormal iron levels play a key role. By quantifying ferritin concentrations, clinicians can evaluate iron status and tailor treatments accordingly.
How is the Vista Ferritin Assay supplied, and what system does it require for use?
The assay is supplied as a reagent kit specifically designed for use with the Syva Vista Immunoassay System, a semi-automated analyzer. This system processes the kit’s components to perform the immunoassay, ensuring accurate ferritin quantification in clinical samples. The kit is not standalone and must be used within this system’s workflow.
Is the Vista Ferritin Assay intended for single-use or repeated use, and what storage conditions are required?
The Vista Ferritin Assay is intended for single-use only in clinical laboratory settings. Before use, it requires refrigeration between 2–8°C—no additional storage precautions are specified. Once opened or used, the kit components should not be reused to maintain accuracy and sterility.
What regulatory pathway does the Vista Ferritin Assay follow, and what classification does it hold?
The assay holds FDA 510(k) clearance (K931576) under product code DBF, classifying it as a Class II device. The decision was issued in 1993 as *Substantially Equivalent* to a predicate device, with the Immunology (IM) Advisory Committee overseeing its review. This classification reflects its role as an in vitro diagnostic tool for ferritin measurement.
Can the Vista Ferritin Assay be used with other immunoassay systems besides the Syva Vista?
No, the Vista Ferritin Assay is exclusively designed for use with the Syva Vista Immunoassay System. The kit’s components and workflow are optimized for compatibility with this analyzer only. Attempting to use it with alternative systems may compromise accuracy or functionality, as the assay relies on the system’s specific processing parameters.