# K111964: Audit Microcv Urine/Fluids Chemistry Linearity

- Pathway: 510(k) (Traditional)
- Applicant: Aalto Scientific, Ltd.
- Decided: Mar 2, 2012 after 235 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.
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 Audit TM MicroCV TM Urine/Fluids Chemistry Linearity Set is assayed quality control material consisting of two sets of five levels of aqueous buffer. Each level of Set 1 contains the following analytes: Phosphorous, Urea Nitrogen, Uric Acid. Each level of Set 2 contains the following analytes: Amylase, Calcium, Glucose, Chloride, Creatinine, Magnesium, Potassium, Sodium, Microprotein, Microalbumnin. These five levels of each set demonstrate a linear relationship to each other for their respective analytes, reagents and instruments. The product is intended for use with quantitative assays on the indicated analyzer specified in the labeling. 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 TM MicroCV TM Urine/Fluids Chemistry Linearity Set is "For In Vitro Diagnostic Use Only".

Source page: https://510kreport.com/device/K111964
Methodology: https://510kreport.com/methodology