Cleared Traditional

K181551 - DAVID One Step Home Use Pregnancy Test ...

K181551 is the FDA 510(k) clearance for DAVID One Step Home Use Pregnancy Test ... by Runbio Biotech Co.,Ltd. It is a Class 2 Chemistry device (product code LCX) cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K181551 · Runbio Biotech Co.,Ltd · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2019
Decision
254d
Days
Class 2
Risk

K181551 is an FDA 510(k) clearance for the DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pre.... Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Runbio Biotech Co.,Ltd (Shantou, CN). The FDA issued a Cleared decision on February 22, 2019 after a review of 254 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.

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Submission Details

510(k) Number K181551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2018
Decision Date February 22, 2019
Days to Decision 254 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
166d slower than avg
Panel avg: 88d · This submission: 254d
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 111
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K181551.
HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream
K192123 · Qingdao Hightop Biotech Co., Ltd. · Sep 2019
VeriClear Digital Early Result Pregnancy Test
K182328 · True Diagnostics, Inc. · May 2019
WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream
K190705 · Wholepower Biotech Co., Ltd. · Apr 2019
Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream
K183097 · Weihai Kangzhou Biotechnology Engineering Co., Ltd. · Jan 2019
Acro HCG Pregnancy Rapid Test
K180771 · Acro Biotech, Inc. · May 2018
David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette
K172627 · Runbio Biotech Co.,Ltd · Mar 2018