Cleared Traditional

K172627 - David Home Pregnancy Test Cassette

K172627 is the FDA 510(k) clearance for David Home Pregnancy Test Cassette by Runbio Biotech Co.,Ltd. It is a Class 2 Chemistry device (product code LCX) cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K172627 · Runbio Biotech Co.,Ltd · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
208d
Days
Class 2
Risk

K172627 is an FDA 510(k) clearance for the David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette. 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 March 28, 2018 after a review of 208 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 Runbio Biotech Co.,Ltd devices

Submission Details

510(k) Number K172627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2017
Decision Date March 28, 2018
Days to Decision 208 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
120d slower than avg
Panel avg: 88d · This submission: 208d
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 K172627.
DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette
K181551 · Runbio Biotech Co.,Ltd · Feb 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
Preview Digital Pregnancy Test
K173229 · Guangzhou Wondfo Biotech Co., Ltd. · Mar 2018
ACRO HCG Pregnancy Rapid Test
K172512 · Acro Biotech, Inc. · Feb 2018
Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream
K150022 · Guangzhou Wondfo Biotech Co., Ltd. · Aug 2015