Cleared Traditional

K112449 - QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST

K112449 is an FDA 510(k) clearance for QUIKRESPONSE ONE STEP MIDSTREAM EARLY P..., manufactured by Tianjin New Bay Bioresearch Co., Ltd.. The device is a Class 2 Chemistry device with product code LCX cleared through the Traditional 510(k) pathway after a 396-day FDA review.

K112449 · Tianjin New Bay Bioresearch Co., Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
396d
Days
Class 2
Risk

K112449 is an FDA 510(k) clearance for the QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Tianjin New Bay Bioresearch Co., Ltd. (Yorba Linda, US). The FDA issued a Cleared decision on September 24, 2012 after a review of 396 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 Tianjin New Bay Bioresearch Co., Ltd. devices

FDA 510(k) Submission Details - K112449

510(k) Number K112449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2011
Decision Date September 24, 2012
Days to Decision 396 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
308d slower than avg
Panel avg: 88d · This submission: 396d
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 K112449.
HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE)
K123703 · Healgen Scientific, LLC · Apr 2013
FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER
K122907 · Polymed Therapeutics, Inc. · Mar 2013
EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II)
K123050 · Nantong Biotechnology Co., Ltd. · Feb 2013
FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST
K103487 · Taidoc Technology Corporation · Oct 2011
PREGNANCY ONE STEP RAPID TEST
K103574 · Lehnus & Associates Consulting · Jul 2011
IND ONE STEP HCG URINE PREGNANCY TEST (STRIP)
K110889 · Ind Diagnostics, Inc. · Jun 2011