# K163629: Audit MicroControls Linearity FD Tumor Markers II

- Pathway: 510(k) (Traditional)
- Applicant: Aalto Scientific, Ltd.
- Decided: Mar 10, 2017 after 78 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- 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)
- K130762: Audit Microcv Therapeutic Drug (TDM) Linearity Set, Aalto Scientific, Ltd. (2013) Summary page 4.

## Indications for use
The Audit® MicroControls™ Linearity FD Tumor Markers II is intended to simulate human patient samples for use as assayed quality control material, determining linearity, calibration verification, and the verification of reportable range for the HE4 and HER2 analytes. The Audit® MicroControls™ Linearity FD Tumor Markers II is for In Vitro Diagnostic use only.

Source page: https://510kreport.com/device/K163629
Methodology: https://510kreport.com/methodology