# K023410: Validate Chem 10 Calibration Verification Test Set, Model 110

- Pathway: 510(k) (Traditional)
- Applicant: Maine Standards Co.
- Decided: Jan 6, 2003 after 88 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 K910440 (1991). 1 ancestor in all.
40 later devices descend from it; 1 cites it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910440: Document Reflectance II Linearity Test Set, Casco Standards (1991) Summary page 1.
- (no number) Ortho-Clinical Diagnostics VITROS Calibrator Kit 4: named in the summary without a submission number

## Most influential descendants
- K042318: Audit Microcv General Chemistry Linearity Set (2004), 39 descendants of its own
- K100715: Audit Microcv Homocysteine Linearity Set, Model 704M-5 (2010), 14 descendants of its own
- K133128: Immulite 2000; HCG Calibration Verification Material, Insulin Calibration Verification Material, Pyrilinks-D Calibration (2013), 13 descendants of its own
- K140258: Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH Calibration Verification Material (2014), 7 descendants of its own
- K101427: Audit Microcv HS-CRP Linearity Set (2010), 5 descendants of its own

## Indications for use
The VALIDATE Chem 10 Calibration Verification Test Set is used by trained laboratory professionals for the determination of linearity, calibration verificatior I and verification of reportable range in automated, semi-automated and manual clinical chemistry systems for the following analytes: alanine aminotransferase, aspartate aminotransferase, gamma-glutarnyl transferase, creatine kinase, lactate dehydrogenase, alkaline phophatase, arnylase, lipase, and total bilirubin The materials may also be utilized on Ortho-Clinical Diagnostic's Vitros analyzers for determining linearity of the Bu/Bc methods.

Source page: https://510kreport.com/device/K023410
Methodology: https://510kreport.com/methodology