# K992397: Accunate-One Step, Accunate-One Step Cassette

- Pathway: 510(k) (Traditional)
- Applicant: Cenogenics Corp.
- Decided: Aug 26, 1999 after 38 days
- Product code: JHI (Visual, Pregnancy Hcg, Prescription Use)
- 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) Abbott Test Pack Plus™: named in the summary without a submission number

## Indications for use
ACCUNATE™-ONE STEP and ACCUNATE™-ONE STEP CASSETTE are rapid lateral flow colloidal gold immunological tests for the qualitative determination of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. The product will be marketed to physician‘s office laboratories, clinics and hospital and reference laboratories.

Source page: https://510kreport.com/device/K992397
Methodology: https://510kreport.com/methodology