# K193318: Distinct® Early Detection Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Aug 20, 2020 after 262 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
Longest line of descent: 4 generations back to K992232 (1999). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123436: First Response Early Result Pregnancy Test, Church & Dwight Co., Inc. (2013) Summary page 5.

## Indications for use
The Distinct® Early Detection Pregnancy Test is an aid for the early detection of pregnancy intended for home use. The device is a chromatographic immunoassay that performs qualitative detection of human chorionic gonadotropin (hCG) in urine. This test can help determine pregnancy as early as 6 days before the day of the missed period (5 days before the day of the expected period).

Source page: https://510kreport.com/device/K193318
Methodology: https://510kreport.com/methodology