Cleared Traditional

K193318 - Distinct® Early Detection Pregnancy Test (FDA 510(k) Clearance)

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

K193318 · ACON Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2020
Decision
262d
Days
Class 2
Risk

K193318 is an FDA 510(k) clearance for the Distinct® Early Detection 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 August 20, 2020 after a review of 262 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 K193318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2019
Decision Date August 20, 2020
Days to Decision 262 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
174d slower than avg
Panel avg: 88d · This submission: 262d
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 225
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K193318.
MissLan® Early Detection Digital Pregnancy Test
K251040 · Guangzhou Decheng Biotechnology Co., Ltd. · Sep 2025
Shinetell PlusTM Digital Early Pregnancy Test
K251053 · Hangzhou AllTest Biotech Co., Ltd. · Jul 2025
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
iHealth® Early Pregnancy Test
K241394 · Andon Health Co, Ltd. · Dec 2024