Cleared Traditional

K232715 - Distinct Digital Pregnancy Test

K232715 is the FDA 510(k) clearance for Distinct Digital Pregnancy Test by ACON Laboratories, Inc.. It is a Class 2 Chemistry device (product code LCX) cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K232715 · ACON Laboratories, Inc. · Chemistry device
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May 2024
Decision
269d
Days
Class 2
Risk

K232715 is an FDA 510(k) clearance for the Distinct® Digital Pregnancy Test. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on May 31, 2024 after a review of 269 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 ACON Laboratories, Inc. devices

Submission Details

510(k) Number K232715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2023
Decision Date May 31, 2024
Days to Decision 269 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
181d slower than avg
Panel avg: 88d · This submission: 269d
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 Consultant

Mcra, LLC
James E. Mullally, PhD.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 111
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K232715.
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
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
ACESO Early Pregnancy Test
K234152 · Aceso Laboratories, Inc. · Apr 2024
FaStep™ Pregnancy Rapid Test Strip
K233174 · Assure Tech. (Hangzhou) Co, Ltd. · Feb 2024