Shinetell PlusTM Digital Early Pregnancy Test
FDA 510(k) K251053 · Hangzhou AllTest Biotech Co., Ltd.
510(k) numberK251053
Submission
- Device name
- Shinetell PlusTM Digital Early Pregnancy Test
- Applicant
- Hangzhou AllTest Biotech Co., Ltd.
Hangzhou, CN - Received
- April 4, 2025
- Decision date
- July 15, 2025
- 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 |
| 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 |
| K241394 | iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test StripLCX · Traditional | Andon Health Co, Ltd. | 12/20/2024SE |
| 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 |
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| K260342 | AllTest Strep A Rapid TestGTY · Traditional | 04/30/2026SE |
| K252607 | AllTest Urinary Tract Infection TestJMT · Traditional | 10/30/2025SE |
| K250727 | AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test CupNFT · Traditional | 04/04/2025SE |
| K242576 | AllTest Viral Transport MediumJSM · Traditional | 04/04/2025SE |
| K244043 | AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test CupNFT · Traditional | 02/27/2025SE |
| K242540 | AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test PanelNFT · Traditional | 09/27/2024SE |
| K241978 | Shinetell Digital Pregnancy TestLCX · Traditional | 08/13/2024SE |
| K241428 | AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test CupNFT · Traditional | 06/17/2024SE |
| K233019 | AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest…DKZ · Traditional | 12/13/2023SE |
| K233417 | AllTest Fentanyl Urine Test CassetteNGL · Traditional | 10/26/2023SE |
Questions and answers
When was Shinetell PlusTM Digital Early Pregnancy Test cleared by the FDA?
Shinetell PlusTM Digital Early Pregnancy Test (K251053) received a 510(k) decision of Substantially Equivalent on July 15, 2025, 102 days after the submission was received.
What is the product code of K251053?
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.