# K031575: Linical Protein 2 Calibration Verifiers Levels a-E for Olympus AU Analyzers

- Pathway: 510(k) (Traditional)
- Applicant: Cliniqa Corporation
- Decided: Jul 23, 2003 after 64 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K072246: Validate SP1 Calibration Verification/Linearity Test Set, Model 601 (2007), 0 descendants of its own

## Indications for use
CLlNlQA LiniCAL'" Protein 2 Calibration Verifiers are intended for use in the clinical laboratory to verify calibration and/or assess linearity of the Ofympus* AU Analyzers. Five assayed levels of Anti Streptolysin 0, C-Reactive Protein. Complement C3, Complement C4, Ferritin, lrnmunoglobulinA, Immunoglobulin G, Immunoglobulin M, Prealbumin and Transferrin are provided to allow monitoring of the reportable range.

Source page: https://510kreport.com/device/K031575
Methodology: https://510kreport.com/methodology