Cleared Traditional

Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream) (K203246) - FDA 510(k) Clearance

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

K203246 · Atlas Link Technology Co., Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2021
Decision
273d
Days
Class 2
Risk

K203246 is an FDA 510(k) clearance for the Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pre.... Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Atlas Link Technology Co., Ltd. (Langfang, CN). The FDA issued a Cleared decision on August 4, 2021 after a review of 273 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 Atlas Link Technology Co., Ltd. devices

Submission Details

510(k) Number K203246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2020
Decision Date August 04, 2021
Days to Decision 273 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
185d slower than avg
Panel avg: 88d · This submission: 273d
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 K203246.
One Step Pregnancy Test
K210341 · Spd Swiss Precision Diagnostics GmbH · Mar 2022
SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream
K212447 · Hangzhou Sejoy Electronics & Instruments Co., Ltd. · Feb 2022
Clearblue® Early Digital Pregnancy Test
K200913 · Spd Swiss Precision Diagnostics GmbH · Aug 2021
Distinct® Early Detection Pregnancy Test
K193318 · ACON Laboratories, Inc. · Aug 2020
hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream
K200133 · Safecare Biotech (Hangzhou) Co., Ltd. · Aug 2020
CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream
K193132 · Hangzhou Clongene Biotech Co., Ltd. · Dec 2019