# K091225: Validate GC1, GC2, GC3 and GC4 Calibration Verification/Linearity Test Set

- Pathway: 510(k) (Traditional)
- Applicant: Maine Standards Co.
- Decided: Jun 25, 2009 after 59 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: 2 generations back to K863751 (1986). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012120: Validate Chem 4 Calibration Verification Test Set, Model 10004, Maine Standards Co. (2001) Summary page 1.
- (no number) VALIDATE® Chem 1 Calibration Verification / Linearity Test Set: named in the summary without a submission number
- (no number) VALIDATE® Chem 2 Calibration Verification / Linearity Test Set: named in the summary without a submission number
- (no number) VALIDATE® Chem 3 Calibration Verification / Linearity Test Set: named in the summary without a submission number
- (no number) VALIDATE® Chem 5 Calibration Verification / Linearity Test Set: named in the summary without a submission number
- (no number) VALIDATE® Chem 6 Calibration Verification / Linearity Test Set: named in the summary without a submission number
- (no number) VALIDATE® Chem 7 Calibration Verification / Linearity Test Set: named in the summary without a submission number

## Most influential descendants
- K153712: VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit (2016), 0 descendants of its own

## Indications for use
Validate® GC Calibration Verification / Linearity Test Sets 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. See attached Package Insert labeling for all analytes claimed.

Source page: https://510kreport.com/device/K091225
Methodology: https://510kreport.com/methodology