Cleared Traditional

K945568 - HCG MIDSTREAM PREGNANCY TEST

K945568 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 68-day FDA review.

K945568 · Mizuho USA, Inc. · Chemistry device
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Jan 1995
Decision
68d
Days
Class 2
Risk

K945568 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 January 17, 1995 after a review of 68 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mizuho USA, Inc. devices

FDA 510(k) Submission Details - K945568

510(k) Number K945568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 1994
Decision Date January 17, 1995
Days to Decision 68 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 88d · This submission: 68d
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 154
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K945568.
SELFCARE EARLY PREGNANCY TEST
K955903 · Cambridge Diagnostics Ireland, Ltd. · Mar 1996
CAMEO HOME PREGNANCY TEST
K954364 · Quidel Corp. · Oct 1995
LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG
K945514 · Princeton BioMeditech Corp. · Feb 1995
PREGNANCY CHECK
K941355 · Sa Scientific, Inc. · Jul 1994
PREDICTOR HOME PREGNANCY TEST
K940637 · Organon Teknika Corp. · Jun 1994
BESURE PLUS/(MIDSTREAM) ONE STEP PREG HOME TEST
K930488 · Syntron Bioresearch, Inc. · Apr 1993