# K062501: Validate Thyroid Calibration Verification / Linearity Test Set, Model 901

- Pathway: 510(k) (Traditional)
- Applicant: Maine Standards Co.
- Decided: Sep 29, 2006 after 35 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 K950469 (1995). 2 ancestors in all.
26 later devices descend from it; 5 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992034: Document Thyroid Cal*Ver, Casco-Nerl Diagnostics Corporation (Maine) (1999) Summary page 1.

## Most influential descendants
- K102904: Enhanced Estradiol (EE2) Master Curve Material (2010), 18 descendants of its own
- K110061: CVM, Unconjugated Estriol (UE3) Calibration Verification Material (2011), 14 descendants of its own
- K133128: Immulite 2000; HCG Calibration Verification Material, Insulin Calibration Verification Material, Pyrilinks-D Calibration (2013), 13 descendants of its own
- K140258: Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH Calibration Verification Material (2014), 7 descendants of its own
- K133124: Immulite 2000; Total T3 Calibration Verification Material, Total T4 Calibration Verification Material, Total TBG Calibra (2013), 5 descendants of its own

## Indications for use
VALIDATE Thyroid Calibration Verification Test Set solutions are for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in chemistry systems for the following analytes: Triiodothyronine (T3), Thyroxine (T4), human Thyroid Stimulating Hormone (TSH), and Cortisol.

Source page: https://510kreport.com/device/K062501
Methodology: https://510kreport.com/methodology