Cleared Traditional

K882192 - HYGEIA URINE PREGNANCY TEST

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

K882192 · Hygeia Sciences · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K882192

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.

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 56
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 BETA QUIK STAT EIA KIT
K882895 · Pacific Biotech, Inc. · Oct 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