Chiron Diagnostics ACS 180 Ferritin Assay
510(k) K992157
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK992157 | Date5 Aug 1999 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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
Overview
AI-generated summary, 1 Oct 2026
The Chiron Diagnostics ACS 180 Ferritin Assay is an in vitro diagnostic device for the quantitative measurement of ferritin in human serum or plasma. Ferritin is a protein that stores iron and serves as a biomarker for iron stores, inflammation, and certain hematologic conditions. This assay is designed to provide accurate and reliable ferritin levels, aiding in the diagnosis and monitoring of conditions such as iron deficiency, iron overload, and inflammatory diseases.
This assay is intended for use in clinical laboratories equipped with the ACS 180 automated chemistry system. Supplied as a reagent kit, it is intended for single-use and requires proper storage at controlled temperatures to maintain stability. The device is classified under FDA regulation number 866.5340 and was granted FDA 510K clearance under the Immunology advisory committee. No MRI safety or reusable components are specified, and compliance with standard laboratory practices for in vitro diagnostics applies.
Other devices from Chiron Diagnostics Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the Chiron Diagnostics ACS 180 Ferritin Assay used for?
The ACS 180 Ferritin Assay is designed for the quantitative measurement of ferritin levels in human serum or plasma. Ferritin is a key biomarker for assessing iron stores, diagnosing iron deficiency or overload, and monitoring inflammatory conditions like anemia or autoimmune diseases. By providing accurate ferritin readings, this assay supports clinical decision-making in hematology and immunology.
How is the ACS 180 Ferritin Assay supplied, and is it single-use?
The assay is supplied as a reagent kit, specifically intended for single-use only. This ensures consistency in results and minimizes contamination risks in clinical laboratory settings. Each kit is engineered to work exclusively with the ACS 180 automated chemistry system, requiring no reuse or reprocessing.
What storage conditions are required to maintain the assay’s stability?
The ACS 180 Ferritin Assay must be stored under controlled temperatures to preserve its stability and performance. While the exact storage conditions are detailed in the accompanying documentation, adherence to standard laboratory protocols for reagent storage—typically refrigerated or frozen, as specified—is critical. Improper storage could compromise accuracy and lead to unreliable ferritin measurements.
Can this assay be used with any chemistry system, or is it specific to the ACS 180?
This assay is exclusively designed for use with the Chiron Diagnostics ACS 180 automated chemistry system. It is not compatible with other systems, as its reagents and workflow are optimized for the ACS 180’s automated processes. Laboratories must confirm system compatibility before use to ensure accurate and reproducible results.
Does the assay include controls, and if so, what are they for?
The ACS 180 Ferritin Assay kit includes controls (as referenced in the product codes), which are essential for validating assay performance. Controls help verify the accuracy, precision, and reliability of ferritin measurements by simulating known ferritin levels. This ensures that the assay functions within expected parameters before patient testing begins, reducing the risk of diagnostic errors.