# K103601: Audit Microcv Immunoassay Linearity Set

- Pathway: 510(k) (Traditional)
- Applicant: Aalto Scientific, Ltd.
- Decided: Jun 10, 2011 after 184 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: 4 generations back to K910440 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062668: Audit Microcv Immunoassay Linearity Set, Aalto Scientific, Ltd. (2006) Summary page 1.

## Indications for use
The AuditTM MicroCVTM Free T4 / Free T3 Linearity Set consists of five levels of human and bovine albumin based matrix. Each level contains the following analytes: Free T4 and Free T3. The five levels demonstrate a linear relationship to each other for their respective analytes, reagents, and instruments. This product may also be used as a quality control material for these 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 automatic analyzers. The AuditTm Free T4 / Free T3 Linearity Set is "For In Vitro Diagnostic Use Only".

Source page: https://510kreport.com/device/K103601
Methodology: https://510kreport.com/methodology