# K100718: Audit Microcv Ammonian/Ethanol Linearity Set, Model K712M-5

- Pathway: 510(k) (Traditional)
- Applicant: Aalto Scientific, Ltd.
- Decided: Sep 3, 2010 after 175 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: 1 generation back to K944338 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944338: Document R Ammonia / Ethanol Calibration Verification Rest Set, Casco Standards (1994) Summary page 1.

## Indications for use
The Audit MicroCV Ammonia/Ethanol Linearity Set is assayed quality control material consisting of five levels protein (bovine) based serum. Each level contains Ammonia and Ethanol analytes. The five levels demonstrate a linear relationship to each other for Ammonia and Ethanol analytes. It is intended to simulate human patient serum samples and to detect systematic analytical deviations of laboratory testing procedures for Ammonia and Ethanol. This product may be used as unassayed quality control material for Ammonia and Ethanol analytes. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling. The Audit MicroCV Ammonia/Ethanol Linearity Set is "For In Vitro Diagnostic Use Only."

Source page: https://510kreport.com/device/K100718
Methodology: https://510kreport.com/methodology