# K963147: Elecsys Calcheck TSH

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Aug 23, 1996 after 10 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.
32 later devices descend from it; 8 cite it directly.
0 of 34 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
- K974383: Elecsys Calcheck Vitamin B12 (1997), 10 descendants of its own
- K060755: Elecsys Vitamin B12 Immunoassay, Calset II and Calcheck (2006), 9 descendants of its own
- K974384: Elecsys Calcheck Folate (1997), 9 descendants of its own
- K043320: Modification to Roche Elecsys Folate II Calcheck II (2004), 8 descendants of its own
- K082340: Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing Reagent, Roche Elecsys Folate Iii Calset, Roche Elecsys (2009), 7 descendants of its own

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

Source page: https://510kreport.com/device/K963147
Methodology: https://510kreport.com/methodology