# K241394: iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip

- Pathway: 510(k) (Traditional)
- Applicant: Andon Health Co, Ltd.
- Decided: Dec 20, 2024 after 218 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: 5 generations back to K992232 (1999). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213379: Clearblue ® Early Pregnancy Test, Spd Swiss Precision Diagnostics GmbH (2022) Summary page 5.

## Indications for use
The iHealth® Early Pregnancy Test is an OTC in vitro diagnostic test used to assess early pregnancy by detecting the presence of the hCG (human chorionic gonadotropin) hormone in urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, i.e., as early as five (5) days before the day of the expected period. The iHealth® Early Pregnancy Test Strip is an OTC in vitro diagnostic test used to assess early pregnancy by detecting the presence of the hCG (human chorionic gonadotropin) hormone in urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, i.e., as early as five (5) days before the day of the expected period.

Source page: https://510kreport.com/device/K241394
Methodology: https://510kreport.com/methodology