# K100750: Audit Microcv Aso Linearity Set, Model K721M-5

- Pathway: 510(k) (Traditional)
- Applicant: Aalto Scientific, Ltd.
- Decided: May 21, 2010 after 66 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: 3 generations back to K910440 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042318: Audit Microcv General Chemistry Linearity Set, Aalto Scientific, Ltd. (2004) Summary page 1.

## Indications for use
The AuditTm MicroCVTm ASO Linearity Set is assayed quality control material consisting of five levels human based serum. Each level contains Anti-streptolysin 0 (ASO) analyte. The five levels demonstrate a linear relationship to each other for Anti-streptolysin 0 (ASO) analyte. It is intended to simulate human patient serum samples for purpose of monitoring the precision and to detect systematic analytical deviations of laboratory testing procedures for Anti-streptolysin 0 (ASO). This product may be used as unassayed quality control material for Anti-streptolysin 0 (ASO) analyte.

Source page: https://510kreport.com/device/K100750
Methodology: https://510kreport.com/methodology