# K090475: Validate CM2 Calibration Verification / Linearity Test Set, Model 402

- Pathway: 510(k) (Traditional)
- Applicant: Maine Standards Co.
- Decided: Apr 16, 2009 after 51 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) VALIDATE® CM1 Calibration Verification / Linearity Test Set: named in the summary without a submission number

## Indications for use
VALIDATE® CM2 Calibration Verification / Linearity Test Set solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable ranpge in automated, semi automated, and manual chemistry systems. Each VALIDATE CM2 Calibration Verification / Linearity Test Set consists of two sets of bottles. Set 1 contains BNP, hs-CRP, Troponin-I, and MPO. Set 2 contains NT-proBNP, hs-CRP, Troponin-T and MPO.

Source page: https://510kreport.com/device/K090475
Methodology: https://510kreport.com/methodology