LCX · Kit, Test, Pregnancy, Hcg, Over The Counter
Clinical Chemistry · 21 CFR 862.1155 · Class 2
Overview
| Product Code | LCX |
|---|---|
| Device Name | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Regulation | 21 CFR 862.1155 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.
Classification Rationale
For early detection of pregnancy: Class II. For any uses other than early detection of pregnancy: Class III.
Recent Cleared Devices (20 of 226)
Showing 20 most recent of 226 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251040 | MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test | Guangzhou Decheng Biotechnology Co., Ltd. | Sep 9, 2025 | SESE |
| K251053 | Shinetell PlusTM Digital Early Pregnancy Test | Hangzhou AllTest Biotech Co., Ltd. | Jul 15, 2025 | SESE |
| K250117 | FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette | Assure Tech., LLC | Feb 13, 2025 | SESE |
| K242135 | Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream | Nanjing Synthgene Medical Technology Co., Ltd. | Jan 31, 2025 | SESE |
| K243573 | FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream | Assure Tech., LLC | Jan 15, 2025 | SESE |
| K241394 | iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip | Andon Health Co, Ltd. | Dec 20, 2024 | SESE |
| K240242 | HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold) | Anhui Deepblue Medical Technology Co., Ltd. | Oct 11, 2024 | SESE |
| K241978 | Shinetell Digital Pregnancy Test | Hangzhou AllTest Biotech Co., Ltd. | Aug 13, 2024 | SESE |
| K240643 | MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream | Guangzhou Decheng Biotechnology Co., Ltd. | Jun 21, 2024 | SESE |
| K232715 | Distinct® Digital Pregnancy Test | ACON Laboratories, Inc. | May 31, 2024 | SESE |
| K233624 | HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Midstream Rx | Hangzhou Aichek Medical Technology Co., Ltd. | Apr 12, 2024 | SESE |
| K234152 | ACESO Early Pregnancy Test | Aceso Laboratories, Inc. | Apr 5, 2024 | SESE |
| K233174 | FaStep Pregnancy Rapid Test Strip; FaStep Pregnancy Rapid Test Midstream | Assure Tech. (Hangzhou) Co, Ltd. | Feb 5, 2024 | SESE |
| K240025 | Clearblue® Early Detection Pregnancy Test | Spd Swiss Precision Diagnostics GmbH | Jan 31, 2024 | SESE |
| K232864 | EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II | Nantong Egens Biotechnology Co., Ltd. | Jan 26, 2024 | SESE |
| K230741 | Macro & Micro-Test HCG Pregnancy Test Midstream | Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. | Oct 13, 2023 | SESE |
| K230038 | MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream) | Guangzhou Decheng Biotechnology Co., Ltd. | Feb 28, 2023 | SESE |
| K222305 | MissLan Digital Pregnancy Rapid Test | Guangzhou Decheng Biotechnology Co., Ltd. | Nov 30, 2022 | SESE |
| K213379 | Clearblue ® Early Pregnancy Test | Spd Swiss Precision Diagnostics GmbH | Sep 21, 2022 | SESE |
| K212418 | hCG One Step Pregnancy Test | Healstone Biotech, Inc. | Jun 30, 2022 | SESE |
Top Applicants
- Unipath , Ltd. — 20 clearances
- ACON Laboratories, Inc. — 10 clearances
- Armkel, LLC — 10 clearances
- Quidel Corp. — 9 clearances
- Syntron Bioresearch, Inc. — 6 clearances
