# K970396: Human Chorionic Gonadotropin Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Dade Chemistry Systems, Inc.
- Decided: Feb 20, 1997 after 17 days
- Product code: JIW (Calibrator, Surrogate)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) aca® plus Human Chorionic Gonadotropin Calibrator: named in the summary without a submission number

## Most influential descendants
- K063754: Dimension Vista (TM) BHCG Flex (R) Reagent Cartridge, and BHCG Calibrator, Model# K6430,KC632 (2007), 0 descendants of its own

## Indications for use
The HCG Calibrator is intended to be used to calibrate the HCG method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module.

Source page: https://510kreport.com/device/K970396
Methodology: https://510kreport.com/methodology