# K130157: Audit Microcv Beta-Hydroxybutyric Acid Linearity Set

- Pathway: 510(k) (Traditional)
- Applicant: Aalto Scientific, Ltd.
- Decided: Mar 19, 2013 after 55 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: 4 generations back to K910440 (1991). 4 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101427: Audit Microcv HS-CRP Linearity Set, Aalto Scientific, Ltd. (2010) Summary page 1.

## Most influential descendants
- K143571: Audit MicroControls Linearity LQ Cystatin-C (2015), 0 descendants of its own
- K143026: Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity (2014), 0 descendants of its own
- K142978: Audit MicroControls Linearity LQ Special Diabetes (2014), 0 descendants of its own

## Indications for use
The Audit® MicroCVTM Beta-Hydroxybutyric Acid Linearity Set is an assayed quality control material consisting of five levels of human based serum. Each level contains Beta-Hydroxybutyric Acid. These five levels demonstrate a linear relationship to each other for Beta-Hydroxybutyric Acid. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification and verification of reportable range for Beta-Hydroxybutyric Acid. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling and may be used as quality control material for Beta-Hydroxybutyric Acid. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The Audit® MicroCVTM Beta-Hydroxybutyric Acid Linearity Set should not be used for calibration or standardization of the Beta-1-ydroxybutyric Acid assay. The Audit@ MicroCVTM Beta-Hydroxybutyric Acid Linearity Set is "For In Vitro Diagnostic Use Only".

Source page: https://510kreport.com/device/K130157
Methodology: https://510kreport.com/methodology