# K030533: Accunate One-Step,Accunate One-Step Cassette, Accunate-Choice, Accunate Home Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Cenogenics Corp.
- Decided: Apr 17, 2003 after 62 days
- Product code: LCX (Kit, Test, Pregnancy, Hcg, Over The Counter)
- 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
- (no number) Quidel's Quick-Vue: named in the summary without a submission number

## Indications for use
Accunate Home Pregnancy Test is an over-the-counter (OTC) one-step qualitative test for the detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy.

Source page: https://510kreport.com/device/K030533
Methodology: https://510kreport.com/methodology