# K143571: Audit MicroControls Linearity LQ Cystatin-C

- Pathway: 510(k) (Traditional)
- Applicant: Aalto Scientific, Ltd.
- Decided: Jan 23, 2015 after 37 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 LQ Cystatin-C 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 the Cystatin-C analyte. The Linearity LQ Cystatin-C is for In Vitro Diagnostic use only.

Source page: https://510kreport.com/device/K143571
Methodology: https://510kreport.com/methodology