Cleared Traditional

K964002 - NATURALE HCG PREGNANCY TES

K964002 is an FDA 510(k) clearance for NATURALE HCG PREGNANCY TES, 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 31-day FDA review.

K964002 · Mizuho USA, Inc. · Chemistry device
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Nov 1996
Decision
31d
Days
Class 2
Risk

K964002 is an FDA 510(k) clearance for the NATURALE HCG PREGNANCY TES. 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 November 7, 1996 after a review of 31 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 - K964002

510(k) Number K964002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1996
Decision Date November 07, 1996
Days to Decision 31 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
57d faster than avg
Panel avg: 88d · This submission: 31d
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 153
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K964002.
ABBOTT ADVISOR ONE-STEP PREGNANCY TEST
K970082 · Abbott Laboratories · Jan 1997
MIDSTREAM ONESTEP PREGNANCY HOME TEST
K963341 · Syntron Bioresearch, Inc. · Dec 1996
FACT PLUS PREGNANCY TEST
K964108 · Direct Access Diagnostics · Nov 1996
EVIDENCE PREGNANCY TEST
K962721 · Saliva Diagnostic Systems · Oct 1996
AFFIRM ONE-STEP HOME PREGNANCY TEST
K962888 · Athena Medical Corp. · Sep 1996
EZ SURE ONESTEP EARLY PREGNANCY TEST
K962580 · Excel Scientific, Inc. · Aug 1996