# K994085: Immulite Turbo HCG, Models LSKCG1, LSKCG5

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Jan 28, 2000 after 56 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) DPC’s IMMULITE® HCG: named in the summary without a submission number

## Indications for use
IMMULITE Turbo HCG is a solid-phase, two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of human chorionic gonadotropin (HCG) in serum, and Heparinized or EDTA plasma. It is intended strictly for in vitro use as an aid in the detection of pregnancy.

Source page: https://510kreport.com/device/K994085
Methodology: https://510kreport.com/methodology