# K012120: Validate Chem 4 Calibration Verification Test Set, Model 10004

- 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 K863751 (1986). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932458: Document Enzyme, Casco Standards (1993) Summary page 1.
- K924493: Document Total and Direct Bilirubin Linearity-Mod, Casco Standards (1993) Summary page 1.
- K863751: Multi-Analyte Lin-Trol, Sigma Diagnostics, Inc. (1986) Summary page 1.

## Most influential descendants
- K091225: Validate GC1, GC2, GC3 and GC4 Calibration Verification/Linearity Test Set (2009), 1 descendant of its own
- K153712: VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit (2016), 0 descendants of its own
- K041975: Validate Lipoprotein Calibration Verification Test Set, Model 501 (2004), 0 descendants of its own

## Indications for use
The VALIDATE Chem 4 Calibration Verification Test Set is used by trained laboratory professionals for quantitatively verifying calibration, validating reportable ranges, and determining linearity of automated, semi-automated and manual chemistry systems for the following analytes: alkaline phosphatase, alanine aminotransferase, amylase, aspartate aminotransferase, creatine kinase, gamma-glutamyl transferase, lactate dehydrogenase, lipase, total bilirubin and direct bilirubin.

Source page: https://510kreport.com/device/K012120
Methodology: https://510kreport.com/methodology