FDA Product Code LCX: Kit, Test, Pregnancy, Hcg, Over The Counter
Leading manufacturers include Unipath , Ltd., ACON Laboratories, Inc. and Armkel, LLC.
226
Total
226
Cleared
104d
Avg days
1978
Since
Declining activity -
8 submissions in the last 2 years
vs 11 in the prior period
Review times increasing: avg
131d
recently vs 103d historically
FDA 510(k) Cleared Kit, Test, Pregnancy, Hcg, Over The Counter Devices (Product Code LCX)
226 devices
Cleared
Sep 09, 2025
MissLan® Early Detection Digital Pregnancy Test
Guangzhou Decheng Biotechnology Co., Ltd.
Chemistry
159d
Cleared
Jul 15, 2025
Shinetell PlusTM Digital Early Pregnancy Test
Hangzhou AllTest Biotech Co., Ltd.
Chemistry
102d
Cleared
Feb 13, 2025
FaStep Pregnancy Rapid Test Cassette
Assure Tech., LLC
Chemistry
28d
Cleared
Jan 31, 2025
Synthgene Home Test HCG Test Strip
Nanjing Synthgene Medical Technology Co., Ltd.
Chemistry
193d
Cleared
Jan 15, 2025
FaStep Early Pregnancy Rapid Test Strip
Assure Tech., LLC
Chemistry
57d
Cleared
Dec 20, 2024
iHealth® Early Pregnancy Test
Andon Health Co, Ltd.
Chemistry
218d
Cleared
Oct 11, 2024
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.
Chemistry
255d
Cleared
Aug 13, 2024
Shinetell Digital Pregnancy Test
Hangzhou AllTest Biotech Co., Ltd.
Chemistry
39d
Cleared
Jun 21, 2024
MissLan® Early Detection Pregnancy Test Strip
Guangzhou Decheng Biotechnology Co., Ltd.
Chemistry
106d
Cleared
May 31, 2024
Distinct® Digital Pregnancy Test
ACON Laboratories, Inc.
Chemistry
269d
Cleared
Apr 12, 2024
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.
Chemistry
151d
Cleared
Apr 05, 2024
ACESO Early Pregnancy Test
Aceso Laboratories, Inc.
Chemistry
98d
Cleared
Feb 05, 2024
FaStep™ Pregnancy Rapid Test Strip
Assure Tech. (Hangzhou) Co, Ltd.
Chemistry
130d
Cleared
Jan 31, 2024
Clearblue® Early Detection Pregnancy Test
Spd Swiss Precision Diagnostics GmbH
Chemistry
28d
Cleared
Jan 26, 2024
EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II
Nantong Egens Biotechnology Co., Ltd.
Chemistry
133d
Cleared
Oct 13, 2023
Macro & Micro-Test HCG Pregnancy Test Midstream
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Chemistry
210d
Cleared
Feb 28, 2023
MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)
Guangzhou Decheng Biotechnology Co., Ltd.
Chemistry
53d
Cleared
Nov 30, 2022
MissLan™ Digital Pregnancy Rapid Test
Guangzhou Decheng Biotechnology Co., Ltd.
Chemistry
121d
Cleared
Sep 21, 2022
Clearblue ® Early Pregnancy Test
Spd Swiss Precision Diagnostics GmbH
Chemistry
343d
Cleared
Jun 30, 2022
hCG One Step Pregnancy Test
Healstone Biotech, Inc.
Chemistry
331d
Cleared
Apr 05, 2022
Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream
Co-Innovation Biotech Co., Ltd.
Chemistry
120d
Cleared
Mar 10, 2022
One Step Pregnancy Test
Spd Swiss Precision Diagnostics GmbH
Chemistry
398d
Cleared
Feb 18, 2022
SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream
Hangzhou Sejoy Electronics & Instruments Co., Ltd.
Chemistry
197d
Cleared
Aug 13, 2021
Clearblue® Early Digital Pregnancy Test
Spd Swiss Precision Diagnostics GmbH
Chemistry
494d
About Product Code LCX - Regulatory Context
510(k) Submission Activity
226 total 510(k) submissions under product code LCX since 1978, with 226 receiving FDA clearance (average review time: 104 days).
Submission volume has declined in recent years - 8 submissions in the last 24 months compared to 11 in the prior period.
FDA 510(k) Review Time - LCX Product Code
Recent submissions under LCX have taken an average of 131 days to reach a decision - up from 103 days historically. Manufacturers should account for longer review timelines in current project planning.
LCX devices are reviewed by the Chemistry panel. Browse all Chemistry devices →