# K110880: Validate (R) GC3 Calibration Verification / Linearity Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Maine Standards Company, LLC
- Decided: Jul 5, 2011 after 97 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. Our reading found no predicate number; beside “510(k)” the summary prints a number our reading could not make out (“14b08-8-o”).
- (no number) VALIDATE® GC3 Calibration Verification / Linearity Test Kit: named in the summary without a submission number

## Indications for use
VALIDATE® GC3 Calibration Verification / Linearity Test Kit is intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range. See the package insert for the list of all analytes claimed.

Source page: https://510kreport.com/device/K110880
Methodology: https://510kreport.com/methodology