Cleared Traditional

K883148 - IMMUKNOW-CHECK HCG ASSAY KIT, CAT. #900-40

K883148 is an FDA 510(k) clearance for IMMUKNOW-CHECK HCG ASSAY KIT, manufactured by Diagnostic Chemicals, Ltd. (Usa). The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K883148

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.

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 54
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 BETA QUIK STAT EIA KIT
K882895 · Pacific Biotech, Inc. · Oct 1988
MODIFIED VENTRESCREEN BETA HCG ENZYME IMMUNOASSAY
K880678 · Ventrex Laboratories, Inc. · Apr 1988