# K083891: Validate Thyroid Calibration Verification Test Set, Model 901

- Pathway: 510(k) (Traditional)
- Applicant: Maine Standards Co.
- Decided: Mar 23, 2009 after 84 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 K950469 (1995). 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)
- K062501: Validate Thyroid Calibration Verification / Linearity Test Set, Model 901, Maine Standards Co. (2006) Summary page 1.

## Indications for use
Each VALIDATE® THY Calibration Verification / Linearity Test Set consists of two sets of bottles, a THY Set and a FT4 Set. The THY set consists of five (5) levels of the following four analytes: triiodothyronine (T3), thyroxine (T4), human thyroid stimulating hormone (TSH), and cortisol, and the FT4 set consists of five (5) levels containing Free T4. VALIDATE® THY Calibration Verification / Linearity Test Set solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in automated, semi automated, and manual chemistry systems.

Source page: https://510kreport.com/device/K083891
Methodology: https://510kreport.com/methodology