# K101226: Audit Microcv RF/CRP Linearity Set

- Pathway: 510(k) (Traditional)
- Applicant: Aalto Scientific, Ltd.
- Decided: Aug 31, 2010 after 120 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: 3 generations back to K910440 (1991). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023661: Linical RF-CRP Calibration Verifiers Levels a-E for Beckman Coulter Synchron CX Systems, Cliniqa Corporation (2002) Summary page 1.
- K012513: Liquichek Lipids Control Level 1, Liquichek Lipids Control Level 2, Models 641 and 642, Bio-Rad (2001) Summary page 1.
- K042318: Audit Microcv General Chemistry Linearity Set, Aalto Scientific, Ltd. (2004) Summary page 1.

## Indications for use
The AuditTM MicroCVTM RF/CRP Linearity Set is an assayed quality control material consisting of five levels human based serum. Each level contains Rheumatoid Factor (RF) and C-Reactive Protein (CRP) analytes. The five levels demonstrate a linear relationship to each other for Rheumatoid Factor (RF) and C-Reactive Protein (CRP) analytes. This product may also be used as unassayed quality control material for Rheumatoid Factor (RF) and C-Reactive Protein (CRP) analytes. 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 for use with quantitative assays on manual, automatic, and semi-automatic analyzers. The AuditTM MicroCVTM RF/CRP Linearity Set is "For In Vitro Diagnostic Use Only".

Source page: https://510kreport.com/device/K101226
Methodology: https://510kreport.com/methodology