Cleared Traditional

K931997 - HCG MIDSTREAM PREGNANCY TEST

K931997 is an FDA 510(k) clearance for HCG MIDSTREAM PREGNANCY TEST, manufactured by Mizuho USA, Inc.. The device is a Class 2 Chemistry device with product code LCX cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K931997 · Mizuho USA, Inc. · Chemistry device
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Sep 1993
Decision
140d
Days
Class 2
Risk

K931997 is an FDA 510(k) clearance for the HCG MIDSTREAM PREGNANCY TEST. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Mizuho USA, Inc. (San Diego, US). The FDA issued a Cleared decision on September 10, 1993 after a review of 140 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K931997

510(k) Number K931997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1993
Decision Date September 10, 1993
Days to Decision 140 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 88d · This submission: 140d
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 213
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K931997.
EVATEST STRIP
K936013 · Boehringer Mannheim Italia Spa · Feb 1994
ADVANCE PREGNANCY TEST MODIFICATION
K934516 · Ortho Pharmaceutical Corp. · Feb 1994
HCG PREGNANCY ONE STEP TEST STRIP
K934830 · Tcpi, Inc. · Dec 1993
BESURE PLUS/(MIDSTREAM) ONE STEP PREG HOME TEST
K930488 · Syntron Bioresearch, Inc. · Apr 1993
PRECISE PREGNANCY
K930640 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1993
LIFESIGN HCG - ONE STEP HOME PREGNANCY TEST
K926308 · Princeton Biomedix · Jan 1993
K931997 · HCG MIDSTREAM PREGNANCY TEST
Download PDF Mizuho USA, Inc.