# K072246: Validate SP1 Calibration Verification/Linearity Test Set, Model 601

- Pathway: 510(k) (Traditional)
- Applicant: Maine Standards Co.
- Decided: Sep 14, 2007 after 32 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 K031575 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031575: Linical Protein 2 Calibration Verifiers Levels a-E for Olympus AU Analyzers, Cliniqa Corporation (2003) Summary page 1.
- K031577: Linical Protein 2 Calibration Verifiers Levels a-E for Beckman Coulter Array Protein Systems, Cliniqa Corporation (2003) Summary page 1.

## Indications for use
VALIDATE® SPI Calibration Verification Test Set solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in automated, semi-automated and manual chemistry systems for the following analytes: Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM), Complement C3 (C3), Complement C4 (C4), al-Antitrypsin (AAT), and Transfernin (TRF).

Source page: https://510kreport.com/device/K072246
Methodology: https://510kreport.com/methodology