Cleared Traditional

ACESO Early Pregnancy Test (K234152) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K234152 · Aceso Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2024
Decision
98d
Days
Class 2
Risk

K234152 is an FDA 510(k) clearance for the ACESO Early Pregnancy Test. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Aceso Laboratories, Inc. (Chino, US). The FDA issued a Cleared decision on April 5, 2024 after a review of 98 days - within the typical 510(k) review window.

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 Aceso Laboratories, Inc. devices

Submission Details

510(k) Number K234152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2023
Decision Date April 05, 2024
Days to Decision 98 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 88d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 49
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K234152.
MissLan® Early Detection Pregnancy Test Strip
K240643 · Guangzhou Decheng Biotechnology Co., Ltd. · Jun 2024
Distinct® Digital Pregnancy Test
K232715 · ACON Laboratories, Inc. · May 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
K233624 · Hangzhou Aichek Medical Technology Co., Ltd. · Apr 2024
FaStep™ Pregnancy Rapid Test Strip
K233174 · Assure Tech. (Hangzhou) Co, Ltd. · Feb 2024
Clearblue® Early Detection Pregnancy Test
K240025 · Spd Swiss Precision Diagnostics GmbH · Jan 2024
EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II
K232864 · Nantong Egens Biotechnology Co., Ltd. · Jan 2024