# K101434: Audit Microcv Procalcitonin Linearity

- Pathway: 510(k) (Traditional)
- Applicant: Aalto Scientific, Ltd.
- Decided: Jul 22, 2010 after 62 days
- Product code: MJX (Kit, Serological, Positive Control)
- 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.
No later device cites it as a predicate yet.
0 of 4 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.

## Indications for use
The AuditTM MicroCVTM Procalcitonin Linearity Set is assayed quality control material consisting of five levels of Procalcitonin analyte in bovine serum albumin. The five levels demonstrate a linear relationship to each other for the Procalcitonin analyte. It is intended to simulate human patient serum samples for the purpose of monitoring the precision and to detect systematic analytical deviations of laboratory testing procedures for Procalcitonin. This product may be used as an assayed quality control material for Procalcitonin analyte.

Source page: https://510kreport.com/device/K101434
Methodology: https://510kreport.com/methodology