# K133550: Validate Ferritin Calibration Verification/ Linearity Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Maine Standards Company, LLC
- Decided: Feb 5, 2014 after 78 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: 2 generations back to K893139 (1989). 2 ancestors in all.
1 later device descends 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)
- K013119: Validate Chem 6 Calibration Verification Test Set Model # 10006, Maine Standards Co. (2001) Summary page 1.

## Most influential descendants
- K142964: VALIDATE Anemia Calibration Verification/ Linearity Test Kit (2015), 0 descendants of its own

## Indications for use
VALIDATE® FERRITIN Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range for the following analyte, ferritin, on automated instrument systems. The product is intended for use with quantitative assays on the indicated analyzers specified in the labeling.

Source page: https://510kreport.com/device/K133550
Methodology: https://510kreport.com/methodology