# K012118: Validate Chem 2 Calibration Verification Test Set, Model 10002

- Pathway: 510(k) (Traditional)
- Applicant: Maine Standards Co.
- Decided: Aug 20, 2001 after 45 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 K870252 (1987). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K870252: Document (TM) Multi-Analyte Linearity Test Set, Casco Standards (1987) Summary page 1.
- K893139: Document (TM) Uric Acid Linearity Test Set, Casco Standards (1989) Summary page 1.
- K881773: Document (TM) Direct Ise Linearity Test Set, Casco Standards (1988) Summary page 1.

## Indications for use
The VALIDATE Chem 2 Calibration Verification Test Set is used by trained laboratory professionals for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the following analytes: carbon dioxide, uric acid, glucose, and urea nitrogen.

Source page: https://510kreport.com/device/K012118
Methodology: https://510kreport.com/methodology