Cleared Traditional

K896642 - MODIFIED LH ENZYME IMMUNOASSAY TEST KIT

K896642 is the FDA 510(k) clearance for MODIFIED LH ENZYME IMMUNOASSAY TEST KIT by Medix Biotech, Inc.. It is a Class 1 Chemistry device (product code CEP) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K896642 · Medix Biotech, Inc. · Chemistry device
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Jan 1990
Decision
67d
Days
Class 1
Risk

K896642 is an FDA 510(k) clearance for the MODIFIED LH ENZYME IMMUNOASSAY TEST KIT. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Medix Biotech, Inc. (Foster City, US). The FDA issued a Cleared decision on January 30, 1990 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1485 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medix Biotech, Inc. devices

Submission Details

510(k) Number K896642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1989
Decision Date January 30, 1990
Days to Decision 67 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
21d faster than avg
Panel avg: 88d · This submission: 67d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CEP Radioimmunoassay, Luteinizing Hormone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1485
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CEP Radioimmunoassay, Luteinizing Hormone

All 68
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K896642.
MILENIA (TM) LH
K902786 · Diagnostic Products Corp. · Oct 1990
CIBA CORNING MAGIC LITE LH IMMUNOASSAY
K902398 · Ciba Corning Diagnostics Corp. · Jun 1990
ENZYMUN TEST(R) LH
K900779 · Boehringer Mannheim Corp. · Apr 1990
TANDEM-E LH IMMUNOENZYMETRIC ASSAY KIT
K895094 · Hybritech, Inc. · Oct 1989
CLEARPLAN EASY
K894579 · Unipath , Ltd. · Oct 1989
LUTEINIZING HORMONE MAB SOLID PHASE COMPONENT SYST
K894279 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1989