Cleared Traditional

K171136 - LIA Pregnancy Test

K171136 is an FDA 510(k) clearance for LIA Pregnancy Test, manufactured by Lia Diagnostics. The device is a Class 2 Chemistry device with product code LCX cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K171136 · Lia Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2017
Decision
217d
Days
Class 2
Risk

K171136 is an FDA 510(k) clearance for the LIA Pregnancy Test. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Lia Diagnostics (Philadelphia, US). The FDA issued a Cleared decision on November 20, 2017 after a review of 217 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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FDA 510(k) Submission Details - K171136

510(k) Number K171136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2017
Decision Date November 20, 2017
Days to Decision 217 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
129d slower than avg
Panel avg: 88d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LCX Device Classification - Class 2, Special Controls

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 165
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K171136.
David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette
K172627 · Runbio Biotech Co.,Ltd · Mar 2018
Preview Digital Pregnancy Test
K173229 · Guangzhou Wondfo Biotech Co., Ltd. · Mar 2018
ACRO HCG Pregnancy Rapid Test
K172512 · Acro Biotech, Inc. · Feb 2018
Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test
K142754 · Sugentech, Inc. · Apr 2016
One Step hCG Pregnancy Test
K150063 · Coretests, Inc. · Oct 2015
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