# K020450: Validate Chem 8 Calibration Verification Test Set; Model 108

- Pathway: 510(k) (Traditional)
- Applicant: Maine Standards Co.
- Decided: Mar 21, 2002 after 38 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 K881773 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K881773: Document (TM) Direct Ise Linearity Test Set, Casco Standards (1988) Summary page 1.

## Indications for use
The VALIDATE Chem 8 Calibration Verification Test Set is used by trained laboratory professionals for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated chemistry systems employing direct ion selective technology to measure the following analytes: lithium, sodium, potassium and chloride.

Source page: https://510kreport.com/device/K020450
Methodology: https://510kreport.com/methodology