Cleared Traditional

MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream) (K230038) - FDA 510(k) Clearance

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

K230038 · Guangzhou Decheng Biotechnology Co., Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2023
Decision
53d
Days
Class 2
Risk

K230038 is an FDA 510(k) clearance for the MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream). Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Guangzhou Decheng Biotechnology Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on February 28, 2023 after a review of 53 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Guangzhou Decheng Biotechnology Co., Ltd. devices

Submission Details

510(k) Number K230038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2023
Decision Date February 28, 2023
Days to Decision 53 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
35d faster than avg
Panel avg: 88d · This submission: 53d
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 K230038.
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
Macro & Micro-Test HCG Pregnancy Test Midstream
K230741 · Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. · Oct 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
hCG One Step Pregnancy Test
K212418 · Healstone Biotech, Inc. · Jun 2022