# K112143: Audit Microcv T-Uptake Linearity

- Pathway: 510(k) (Traditional)
- Applicant: Aalto Scientific, Ltd.
- Decided: Jan 31, 2012 after 189 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: 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
Audit® MicroCV™ T-Uptake Calibration/Verification Set consists of five levels of human and bovine albumin based serum containing T-Uptake. The Audit® MicroCV™ T-Uptake Calibration/Verification Set is a quality control material intended for use in the quantitative verification of calibration and reportable range of the Roche T-uptake Assay when performed on the P-Modular Analyzer 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 Audit® MicroCV™ T-Uptake Calibration/Verification is for In Vitro Diagnostic use only.

Source page: https://510kreport.com/device/K112143
Methodology: https://510kreport.com/methodology