Cleared Traditional

hCG One Step Pregnancy Test (K212418) - FDA 510(k) Clearance

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

K212418 · Healstone Biotech, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Jun 2022
Decision
331d
Days
Class 2
Risk

K212418 is an FDA 510(k) clearance for the hCG One Step Pregnancy Test. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Healstone Biotech, Inc. (Vancouver, CA). The FDA issued a Cleared decision on June 30, 2022 after a review of 331 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Healstone Biotech, Inc. devices

Submission Details

510(k) Number K212418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2021
Decision Date June 30, 2022
Days to Decision 331 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
243d slower than avg
Panel avg: 88d · This submission: 331d
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

Axteria Biomed Consulting
Guang Gao

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 49
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K212418.
MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)
K230038 · Guangzhou Decheng Biotechnology Co., Ltd. · Feb 2023
MissLan™ Digital Pregnancy Rapid Test
K222305 · Guangzhou Decheng Biotechnology Co., Ltd. · Nov 2022
Clearblue ® Early Pregnancy Test
K213379 · Spd Swiss Precision Diagnostics GmbH · Sep 2022
Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream
K213808 · Co-Innovation Biotech Co., Ltd. · Apr 2022
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