# K101216: Audit Microcv Protein Linearity Set

- Pathway: 510(k) (Traditional)
- Applicant: Aalto Scientific, Ltd.
- Decided: Jan 14, 2011 after 259 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). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 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
- K112742: Audit Microlq Spinal Fluid Control (2012), 0 descendants of its own
- K112705: Audit (R) Microlq (TM) Serum Protein Control (2012), 0 descendants of its own

## Indications for use
The AuditTM MicroCVTM Protein Linearity is assayed quality control material consisting of five levels protein (human) based serum. Each level contains Alpha-lI-Antitrypsin, Complement C3, Complement C4, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M and Transferrin analytes. The five levels demonstrate a linear relationship to each other for Alpha-1I-Antitrypsin, Complement C3, Complement C4, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M, and Transferrin analytes. It is intended to simulate human patient serum samples and to detect systematic analytical deviations of laboratory testing procedures for Alpha-l -Antitrypsin, Complement C3, Complement C4, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M, and Transferrin. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling. The Audit MicroCV Protein Linearity Set is "For In Vitro Diagnostic Use Only."

Source page: https://510kreport.com/device/K101216
Methodology: https://510kreport.com/methodology