Cleared Traditional

K882896 - ONE-STEP HCG

K882896 is the FDA 510(k) clearance for ONE-STEP HCG by Wampole Laboratories. It is a Class 2 Chemistry device (product code DHA) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K882896 · Wampole Laboratories · Chemistry device
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Oct 1988
Decision
112d
Days
Class 2
Risk

K882896 is an FDA 510(k) clearance for the ONE-STEP HCG. Classified as System, Test, Human Chorionic Gonadotropin (product code DHA), Class II - Special Controls.

Submitted by Wampole Laboratories (Cranbury, US). The FDA issued a Cleared decision on October 31, 1988 after a review of 112 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.

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Submission Details

510(k) Number K882896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1988
Decision Date October 31, 1988
Days to Decision 112 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 88d · This submission: 112d
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 K882896.
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