# K013119: Validate Chem 6 Calibration Verification Test Set Model # 10006

- Pathway: 510(k) (Traditional)
- Applicant: Maine Standards Co.
- Decided: Nov 16, 2001 after 59 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- 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 K893139 (1989). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K893139: Document (TM) Uric Acid Linearity Test Set, Casco Standards (1989) Summary page 1.

## Most influential descendants
- K133550: Validate Ferritin Calibration Verification/ Linearity Test Kit (2014), 1 descendant of its own
- K142964: VALIDATE Anemia Calibration Verification/ Linearity Test Kit (2015), 0 descendants of its own

## Indications for use
The VALIDATE Chem 6 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 analyte: uric acid.

Source page: https://510kreport.com/device/K013119
Methodology: https://510kreport.com/methodology