# K963167: Elecys Calcheck T 3

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Aug 27, 1996 after 13 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: 1 generation back to K924862 (1992). 1 ancestor in all.
17 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924862: Aia-Pack HCG Calibration Verification Test Set, Tosoh Medics, Inc. (1992) Summary page 1.

## Most influential descendants
- K111552: Elecsys T3 Calcheck 5 (2011), 16 descendants of its own
- K112528: Elecsys T4 Calcheck 5 (2011), 15 descendants of its own
- K113546: Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys Vitamin D Calcheck 5 (2012), 8 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
- K162840: Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5 (2017), 4 descendants of its own

## Indications for use
Elecsys CalCheck T 3 is intended for use in the quantitative verification of the calibration curve established by the Elecsys T 3 reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers.

Source page: https://510kreport.com/device/K963167
Methodology: https://510kreport.com/methodology