Cleared Traditional

K883148 - IMMUKNOW-CHECK HCG ASSAY KIT

K883148 is the FDA 510(k) clearance for IMMUKNOW-CHECK HCG ASSAY KIT by Diagnostic Chemicals, Ltd. (Usa). It is a Class 2 Chemistry device (product code DHA) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K883148 · Diagnostic Chemicals, Ltd. (Usa) · Chemistry device
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Dec 1988
Decision
132d
Days
Class 2
Risk

K883148 is an FDA 510(k) clearance for the IMMUKNOW-CHECK HCG ASSAY KIT, CAT. #900-40. Classified as System, Test, Human Chorionic Gonadotropin (product code DHA), Class II - Special Controls.

Submitted by Diagnostic Chemicals, Ltd. (Usa) (Charlottestown,Pei,Canada, CA). The FDA issued a Cleared decision on December 5, 1988 after a review of 132 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 Diagnostic Chemicals, Ltd. (Usa) devices

Submission Details

510(k) Number K883148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1988
Decision Date December 05, 1988
Days to Decision 132 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 88d · This submission: 132d
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 44
Devices cleared under the same product code (DHA) and FDA review panel - the closest regulatory comparables to K883148.
VIS-DISK HCG (EIA) LYOPHILIZED JPL-044M
K891095 · Leeco Diagnostics, Inc. · Jun 1989
VIS-DISK HCG (EIA) JPL-041M
K891096 · Leeco Diagnostics, Inc. · Jun 1989
SERUM HCG MICROASSAY
K884430 · Diamedix Corp. · 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