# K101427: Audit Microcv HS-CRP Linearity Set

- Pathway: 510(k) (Traditional)
- Applicant: Aalto Scientific, Ltd.
- Decided: Dec 23, 2010 after 216 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.
5 later devices descend from it; 2 cite it directly.
0 of 9 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.

## Most influential descendants
- K130157: Audit Microcv Beta-Hydroxybutyric Acid Linearity Set (2013), 3 descendants of its own
- 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
- K130764: Audit Microcv Vitamin D Linearity Set (2013), 0 descendants of its own

## Indications for use
The AuditTM NieroCVTM- hs-CRP Linearity Set is assayed quality control material consisting of live levels human based serum. Each level contains High Sensitivity C-Reactive Protein ([is - CRP) analyte. The five levels demonstrate a linear relationship to each other for High Sensitivity C-Reactive Protein (hts -CRP) anaiyte. It is intended to simulate human patient serum samples for purpose of monitoring and detecting systematic analytical deviations of laboratory testing procedures for High Sensitivity C-Reactive Protein (hs -CRPI). This product may be used as quality control material for High Sensitivity C-Reactive Protein (hs -CRP) analyte. 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 product is intended Mbr use with quantitative assays on the indicated analyzer provided in the labeling. The AuditTM MicroCVTrm hs-CRP Linearity Set is "For In Vitro Diagnostic Use Only".

Source page: https://510kreport.com/device/K101427
Methodology: https://510kreport.com/methodology