# K182328: VeriClear Digital Early Result Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: True Diagnostics, Inc.
- Decided: May 15, 2019 after 261 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)
- K123567: First Response Gold Digital Pregnancy Test, Church & Dwight Co., Inc. (2013) Summary page 7.

## Indications for use
VeriClear Digital Early Result Pregnancy Test is a rapid chromatographic immunoassay for qualitative detection of human chorionic gonadotropin (hCQ) in urine, as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.

Source page: https://510kreport.com/device/K182328
Methodology: https://510kreport.com/methodology