Cleared Traditional

K000844 - ABSOLUTE HCG PREGNANCY TEST

K000844 is an FDA 510(k) clearance for ABSOLUTE HCG PREGNANCY TEST, manufactured by Mizuho USA, Inc.. The device is a Class 2 Chemistry device with product code DHA cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K000844 · Mizuho USA, Inc. · Chemistry device
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Jun 2000
Decision
93d
Days
Class 2
Risk

K000844 is an FDA 510(k) clearance for the ABSOLUTE HCG PREGNANCY TEST. Classified as System, Test, Human Chorionic Gonadotropin (product code DHA), Class II - Special Controls.

Submitted by Mizuho USA, Inc. (San Diego, US). The FDA issued a Cleared decision on June 16, 2000 after a review of 93 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.

View all Mizuho USA, Inc. devices

FDA 510(k) Submission Details - K000844

510(k) Number K000844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2000
Decision Date June 16, 2000
Days to Decision 93 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
5d slower than avg
Panel avg: 88d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHA Device Classification - Class 2, Special Controls

Product Code DHA System, Test, Human Chorionic Gonadotropin
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 - DHA System, Test, Human Chorionic Gonadotropin

All 55
Devices cleared under the same product code (DHA) and FDA review panel - the closest regulatory comparables to K000844.
STRATUS CS STAT FLUOROMETRIC ANALYZER BHCG TESTPAK,TEST SYSTEM, MODEL CBHCG, BHCG CALPAK,MODEL CBHCG-C, BHCG DILPAK, MOD
K003696 · Dade Behring, Inc. · Jan 2001
ELECSYS HCG AND BETA TEST SYSTEM
K003178 · Roche Diagnostics Corp. · Dec 2000
ELECSYS HCG TEST SYSTEM
K002148 · Roche Diagnostics Corp. · Aug 2000
IMMULITE TURBO HCG, MODELS LSKCG1, LSKCG5
K994085 · Diagnostic Products Corp. · Jan 2000
DRX QT. HCG
K991532 · Metrika, Inc. · Sep 1999
INSURE PREGNANCY TEST
K991515 · Inbios Intl., Inc. · May 1999