Cleared Traditional

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

K891096 is an FDA 510(k) clearance for VIS-DISK HCG (EIA) JPL-041M, manufactured by Leeco Diagnostics, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K891096

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.

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 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