Cleared Traditional

K891096 - VIS-DISK HCG (EIA) JPL-041M

K891096 is the FDA 510(k) clearance for VIS-DISK HCG (EIA) JPL-041M by Leeco Diagnostics, Inc.. It is a Class 2 Chemistry device (product code DHA) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K891096 · Leeco Diagnostics, Inc. · Chemistry device
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Jun 1989
Decision
106d
Days
Class 2
Risk

K891096 is an FDA 510(k) clearance for the VIS-DISK HCG (EIA) JPL-041M. Classified as System, Test, Human Chorionic Gonadotropin (product code DHA), Class II - Special Controls.

Submitted by Leeco Diagnostics, Inc. (Southfield, US). The FDA issued a Cleared decision on June 16, 1989 after a review of 106 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 Leeco Diagnostics, Inc. devices

Submission Details

510(k) Number K891096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1989
Decision Date June 16, 1989
Days to Decision 106 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 88d · This submission: 106d
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 K891096.
STRATUS(R) HCG FLUOROMETRIC ENZYME IMMUNOASSAY
K913236 · Baxter Healthcare Corp · Aug 1991
STATUS HCG FLUOROMETRIC ENZYME
K893577 · Baxter Healthcare Corp · Aug 1989
VIS-DISK HCG (EIA) LYOPHILIZED JPL-044M
K891095 · Leeco Diagnostics, Inc. · Jun 1989
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