Cleared Traditional

K882192 - HYGEIA URINE PREGNANCY TEST

K882192 is the FDA 510(k) clearance for HYGEIA URINE PREGNANCY TEST by Hygeia Sciences. It is a Class 2 Chemistry device (product code DHA) cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K882192 · Hygeia Sciences · Chemistry device
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Nov 1988
Decision
169d
Days
Class 2
Risk

K882192 is an FDA 510(k) clearance for the HYGEIA URINE PREGNANCY TEST. Classified as System, Test, Human Chorionic Gonadotropin (product code DHA), Class II - Special Controls.

Submitted by Hygeia Sciences (Newton, US). The FDA issued a Cleared decision on November 10, 1988 after a review of 169 days - an extended review 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: 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 Hygeia Sciences devices

Submission Details

510(k) Number K882192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1988
Decision Date November 10, 1988
Days to Decision 169 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 88d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 45
Devices cleared under the same product code (DHA) and FDA review panel - the closest regulatory comparables to K882192.
SERUM HCG MICROASSAY
K884430 · Diamedix Corp. · Dec 1988
IMMUKNOW-CHECK HCG ASSAY KIT, CAT. #900-40
K883148 · Diagnostic Chemicals, Ltd. (Usa) · Dec 1988
RESUBMITTED ABBOTT TESTPACK(TM) HCG COMBO
K884207 · Abbott Laboratories · Dec 1988
MODIFIED VENTRESCREEN BETA HCG ENZYME IMMUNOASSAY
K880678 · Ventrex Laboratories, Inc. · Apr 1988
HCG ENZYME IMMUNOASSAY TEST KIT CATALOG #MB-1013
K873872 · Medix Biotech, Inc. · Oct 1987
ENZYMUN-TEST HCG
K862108 · Boehringer Mannheim Corp. · Aug 1986