# K961792: Biocircuits Ios Serum Pregnancy Test Cartridges/Immunoassay Controls

- Pathway: 510(k) (Traditional)
- Applicant: Biocircuits Corp.
- Decided: Aug 21, 1996 after 104 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) Hybritech ICON II hCG ImmunoConcentration Assay: named in the summary without a submission number

## Indications for use
The IOS™ Serum Pregnancy Test Cartridge is to be used for the qualitative determination of human chorionic gonadotropin (hCG) in serum for the early detection of pregnancy. It is intended to be used with the IOS™ instrument in clinical laboratories, physicians' office laboratories, and other alternate sites of use close to the point of patient care. The IOS™ Immunoassay Controls Kit is to be used to assist in monitoring accuracy and precision in the IOS™ immunoassay test cartridges.

Source page: https://510kreport.com/device/K961792
Methodology: https://510kreport.com/methodology