# K961351: HCG ER Method for the Technicon Immuno 1 System in-Vitro Diagnostic Clinical Method

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Jun 3, 1996 after 59 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Technicon Immuno 1 hCG method: named in the summary without a submission number

## Indications for use
This in vitro diagnostic procedure is intended to quantitatively measure human chorionic gonadotropin (hCG) in human serum on the Technicon Immuno 1° system. Measurements of human chorionic gonadotropin are used for the detection of pregnancy. This method is an adaptation of an existing Technicon Immuno 1 hCG method and has an extended range from 800 mIU/mL to 100,000 mIU/mL. This diagnostic method is not intended for use on any other system.

Source page: https://510kreport.com/device/K961351
Methodology: https://510kreport.com/methodology