# K112742: Audit Microlq Spinal Fluid Control

- Pathway: 510(k) (Traditional)
- Applicant: Aalto Scientific, Ltd.
- Decided: Jun 15, 2012 after 268 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)
- K101216: Audit Microcv Protein Linearity Set, Aalto Scientific, Ltd. (2011) Summary page 3.

## Indications for use
Audit® MicroLQ' h Spinal Fluid Control is a quality control material intended for monitoring the precision of laboratory testing procedures. 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@ MicroLQTM Spinal Fluid is for In Vitro Diagnostic use only.

Source page: https://510kreport.com/device/K112742
Methodology: https://510kreport.com/methodology