# K012119: Validate Chem 3 Calibration Verification Test Set, Model 10003

- 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 K883861 (1988). 2 ancestors in all.
4 later devices descend from it; 1 cites 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)
- K883861: Document (TM) Protein/Cholesterol Linearity Test, Casco Standards (1988) Summary page 1.
- K893142: Document (TM) Iron, Magnes, Trigly Linear Test Set, Casco Standards (1989) Summary page 1.

## Most influential descendants
- K022401: PTS Panels Multi-Chemistry Controls (2002), 3 descendants of its own
- K090405: Lipidpro System (2009), 1 descendant of its own
- K160282: SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System (2017), 0 descendants of its own
- K130295: Lipidpro Lipid Profile and Glucose Measuring System, Lipidpro Professional Lipid Profile and Glucose Measuring System. (2013), 0 descendants of its own

## Indications for use
The VALIDATE Chem 3 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: total protein, albumin, cholesterol, and iron.

Source page: https://510kreport.com/device/K012119
Methodology: https://510kreport.com/methodology