iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip
FDA 510(k) K241394 · Andon Health Co, Ltd.
510(k) numberK241394
Submission
- Device name
- iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip
- Applicant
- Andon Health Co, Ltd.
Tianjin, CN - Received
- May 16, 2024
- Decision date
- December 20, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LCX – Kit, Test, Pregnancy, Hcg, Over The Counter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1155
- Specialty
- Clinical Chemistry
Other 510(k)s with product code LCX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251040 | MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy…LCX · Traditional | Guangzhou Decheng Biotechnology Co., Ltd. | 09/09/2025SE |
| K251053 | Shinetell PlusTM Digital Early Pregnancy TestLCX · Traditional | Hangzhou AllTest Biotech Co., Ltd. | 07/15/2025SE |
| K250117 | FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteLCX · Traditional | Assure Tech., LLC | 02/13/2025SE |
| K242135 | Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene…LCX · Traditional | Nanjing Synthgene Medical Technology Co., Ltd. | 01/31/2025SE |
| K243573 | FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette…LCX · Traditional | Assure Tech., LLC | 01/15/2025SE |
| K240242 | HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette…LCX · Traditional | Anhui Deepblue Medical Technology Co., Ltd. | 10/11/2024SE |
| K241978 | Shinetell Digital Pregnancy TestLCX · Traditional | Hangzhou AllTest Biotech Co., Ltd. | 08/13/2024SE |
| K240643 | MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test…LCX · Traditional | Guangzhou Decheng Biotechnology Co., Ltd. | 06/21/2024SE |
| K232715 | Distinct® Digital Pregnancy TestLCX · Traditional | ACON Laboratories, Inc. | 05/31/2024SE |
| K233624 | HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One…LCX · Traditional | Hangzhou Aichek Medical Technology Co., Ltd. | 04/12/2024SE |
More from Hangzhou Aichek Medical Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K251113 | iHealth Compare Wireless Blood Pressure Monitor(BP-300C);iHealth Compare Pro Wireless…DXN · Abbreviated | 08/04/2025SE |
| K234041 | Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic…DXN · Abbreviated | 04/22/2024SE |
| K222869 | Arm Blood Pressure MonitorDXN · Abbreviated | 02/15/2023SE |
| K222867 | AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)NUH · Abbreviated | 12/21/2022SE |
| K212598 | iHealth infrared Ear thermometer PT5FLL · Abbreviated | 01/28/2022SE |
| K210768 | Wrist Blood Pressure Monitor, Blood Pressure MonitorDXN · Abbreviated | 07/30/2021SE |
| K210770 | Arm Blood Pressure Monitor, Wireless Blood Pressure MonitorDXN · Abbreviated | 07/29/2021SE |
| K202753 | iHealth Wireless No-Touch Forehead ThermometerFLL · Traditional | 03/08/2021SE |
| K202791 | iHealth Clinical Digital ThermometerFLL · Abbreviated | 01/05/2021SE |
| K201380 | Livocare Surgical MaskFXX · Abbreviated | 10/07/2020SE |
Questions and answers
When was iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip cleared by the FDA?
iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip (K241394) received a 510(k) decision of Substantially Equivalent on December 20, 2024, 218 days after the submission was received.
What is the product code of K241394?
The FDA product code is LCX – Kit, Test, Pregnancy, Hcg, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.1155.