Cleared Traditional

K241394 - iHealth® Early Pregnancy Test

Also marketed or referenced as:
iHealth® Early Pregnancy Test Strip

K241394 is an FDA 510(k) clearance for iHealth Early Pregnancy Test, manufactured by Andon Health Co, Ltd.. The device is a Class 2 Chemistry device with product code LCX cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K241394 · Andon Health Co, Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2024
Decision
218d
Days
Class 2
Risk

K241394 is an FDA 510(k) clearance for the iHealth® Early Pregnancy Test. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Andon Health Co, Ltd. (Tianjin, CN). The FDA issued a Cleared decision on December 20, 2024 after a review of 218 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Andon Health Co, Ltd. devices

FDA 510(k) Submission Details - K241394

510(k) Number K241394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2024
Decision Date December 20, 2024
Days to Decision 218 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 88d · This submission: 218d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LCX Device Classification - Class 2, Special Controls

Product Code LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1155
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - LCX Kit, Test, Pregnancy, Hcg, Over The Counter

All 174
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K241394.
FaStep Pregnancy Rapid Test Cassette
K250117 · Assure Tech., LLC · Feb 2025
Synthgene Home Test HCG Test Strip
K242135 · Nanjing Synthgene Medical Technology Co., Ltd. · Jan 2025
FaStep Early Pregnancy Rapid Test Strip
K243573 · Assure Tech., LLC · Jan 2025
HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold)
K240242 · Anhui Deepblue Medical Technology Co., Ltd. · Oct 2024
Shinetell Digital Pregnancy Test
K241978 · Hangzhou AllTest Biotech Co., Ltd. · Aug 2024
MissLan® Early Detection Pregnancy Test Strip
K240643 · Guangzhou Decheng Biotechnology Co., Ltd. · Jun 2024