# K062668: Audit Microcv Immunoassay Linearity Set

- Pathway: 510(k) (Traditional)
- Applicant: Aalto Scientific, Ltd.
- Decided: Oct 16, 2006 after 38 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
- K112143: Audit Microcv T-Uptake Linearity (2012), 0 descendants of its own
- K103601: Audit Microcv Immunoassay Linearity Set (2011), 0 descendants of its own

## Indications for use
The AuditTM MicroCVTM Immunoassay Linearity Set consists of five levels in Human and Bovine serum albumin matrix. Each level contains the following analytes: Cortisol, Digoxin, Estradiol, Ferritin, Folate, Free T4, FSH, hCG, LH, Progesterone, Prolactin, Testosterone, Total PSA, Total T3, Total T4, TSH, and Vitamin B12. The five levels demonstrate a linear relationship to each other for their respective analytes, reagents, and instruments. This product may be used for proficiency testing in interlaboratory surveys and to perform CLIA directed calibration verification for these same analytes with similar reagents on similar instrumentation in accordance with current CLIA-88 guidelines and regulations. In addition, Level A - E of this product may be used as unassayed quality control material for these analytes or as an assayed quality control material for the analyzer systems specified in the package insert. It is not intended to be used as an assayed quality control material for any other analyzer systems.

Source page: https://510kreport.com/device/K062668
Methodology: https://510kreport.com/methodology