# K143026: Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity

- Pathway: 510(k) (Traditional)
- Applicant: Aalto Scientific, Ltd.
- Decided: Nov 21, 2014 after 31 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K910440 (1991). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130157: Audit Microcv Beta-Hydroxybutyric Acid Linearity Set, Aalto Scientific, Ltd. (2013) Summary page 4.

## Indications for use
The Linearity FD Unsaturated Iron Binding Capacity is an assayed quality control material intended to simulate human patient samples for use in determining linearity, calibration verification, and the verification of reportable range for unsaturated iron binding capacity. Linearity FD Unsaturated Iron Binding Capacity is for In Vitro Diagnostic use only.

Source page: https://510kreport.com/device/K143026
Methodology: https://510kreport.com/methodology