# K063754: Dimension Vista (TM) BHCG Flex (R) Reagent Cartridge, and BHCG Calibrator, Model# K6430,KC632

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Feb 23, 2007 after 66 days
- Product code: DHA (System, Test, Human Chorionic Gonadotropin)
- Device class: 2
- Regulation: 21 CFR 862.1155
- 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 K970396 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970387: Human Chorionic Gonadotropin Method, Dade Chemistry Systems, Inc. (1997) Summary page 1.
- K970396: Human Chorionic Gonadotropin Calibrator, Dade Chemistry Systems, Inc. (1997) Summary page 1.

## Indications for use
The BHCG method is an in vitro diagnostic assay for the quantitative measurement of total Beta (f3) human chorionic gonadotropin: both the intact hCG dimer and the free [3 subunit of human chorionic gonadotropin hormone in human serum and plasma on the Dimension Vistalm system. Measurements of j3 human chorionic gonadotropin are used for the early detection of pregnancy. The BHCG calibrator is an in vitro diagnostic product for the calibration of the Beta Human Chorionic Gonadotropin method for the Dimension VistaTm System.

Source page: https://510kreport.com/device/K063754
Methodology: https://510kreport.com/methodology