# K963165: Elecsys Calcheck HCG

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Aug 30, 1996 after 16 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.
No later device cites it as a predicate yet.
0 of 2 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.

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

Source page: https://510kreport.com/device/K963165
Methodology: https://510kreport.com/methodology