# K012122: Validate Chem 5 Calibration Verification Test Set, Model 10005

- Pathway: 510(k) (Traditional)
- Applicant: Maine Standards Co.
- Decided: Aug 20, 2001 after 45 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 K893142 (1989). 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)
- K893142: Document (TM) Iron, Magnes, Trigly Linear Test Set, Casco Standards (1989) Summary page 1.

## Indications for use
The VALIDATE Chem 5 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: iron.

Source page: https://510kreport.com/device/K012122
Methodology: https://510kreport.com/methodology