# K023352: Validate Chem 9 Calibration Verification Test Set, Model 109

- Pathway: 510(k) (Traditional)
- Applicant: Maine Standards Co.
- Decided: Nov 22, 2002 after 46 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 K950469 (1995). 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)
- K950469: Document Serum Multianalyte Calibration Verification Test Set, Casco Standards (1995) Summary page 1.
- (no number) Ortho-Clinical Diagnostics VITROS Calibrator Kit 1: named in the summary without a submission number

## Indications for use
The VALIDATE Chem 9 Calibration Verification Test Set is used by trained laboratory professionals for the quantitative determination of linearity, calibration verification and verification of reportable range in automated, semi-automated, and manual clinical chemistry systems for the following eighteen analytes: albumin, calcium, cholesterol, chloride, carbon dioxide, creatinine, glucose, iron, lactate, lithium, magnesium, phosphorus, potassium, sodium, total protein, triglyceride, urea nitrogen, and uric acid.

Source page: https://510kreport.com/device/K023352
Methodology: https://510kreport.com/methodology