# K142964: VALIDATE Anemia Calibration Verification/ Linearity Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Maine Standards Company, LLC
- Decided: Apr 30, 2015 after 198 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: 3 generations back to K893139 (1989). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133550: Validate Ferritin Calibration Verification/ Linearity Test Kit, Maine Standards Company, LLC (2014) Summary page 4.

## Indications for use
VALIDATE® Anemia 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 analytes: Ferritin Set: ferritin (FERR), Vitamin B12 / Folate Set: vitamin B12(VITB) and folate (FOL), 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/K142964
Methodology: https://510kreport.com/methodology