# K030528: Atac Iron Reagent, Atac Tibc Column Kit and Iron Calibrator (500 UG/DL)

- Pathway: 510(k) (Traditional)
- Applicant: Clinical Data
- Decided: Jun 17, 2003 after 118 days
- Product code: JIY (Photometric Method, Iron (Non-Heme))
- Device class: 1
- Regulation: 21 CFR 862.1410
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Beckman Synchron Systems Iron Reagent, product 467910: named in the summary without a submission number
- (no number) Beckman Synchron Systems FedBCT Calibrator, product 442772: named in the summary without a submission number
- (no number) Beckman Synchron Systems Total Iron Binding Capacity (IBCT) Column Kit, product no. 465976: named in the summary without a submission number

## Indications for use
The ATAC Iron Reagent Kit, which contains both reagent and calibrator, is intended for use with the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of total iron in serum. The ATAC TIBC Column Kit, which is marketed with generic labeling and an ATAC 8000 Application Sheet, is intended for up with the ATAC Iron Reagent Kit and other iron reagents for the quantitative determination of total iron binding capacity in serum. Total iron results are used for the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease. Total iron binding capacity measurements are used for the diagnosis and treatment of anemia. This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.

Source page: https://510kreport.com/device/K030528
Methodology: https://510kreport.com/methodology