# K992034: Document Thyroid Cal*Ver

- Pathway: 510(k) (Traditional)
- Applicant: Casco-Nerl Diagnostics Corporation (Maine)
- Decided: Jul 23, 1999 after 37 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: 1 generation back to K950469 (1995). 1 ancestor in all.
29 later devices descend from it; 3 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950469: Document Serum Multianalyte Calibration Verification Test Set, Casco Standards (1995) Summary page 1.

## Most influential descendants
- K062501: Validate Thyroid Calibration Verification / Linearity Test Set, Model 901 (2006), 26 descendants of its own
- 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

## Indications for use
DOCUMENT Thyroid CAL « VER contains assayed solutions intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range on immunochemistry systems and clinical chemistry systems for the following analytes: Thyroxine (T4), Triiodothyronine (T3) and Thyroid Stimulating Hormone (TSH).

Source page: https://510kreport.com/device/K992034
Methodology: https://510kreport.com/methodology