Cleared Traditional

K870452 - SS-DNA EIA DIAGNOSTIC KIT

K870452 is the FDA 510(k) clearance for SS-DNA EIA DIAGNOSTIC KIT by Biohytech International, Inc.. It is a Class 2 Immunology device (product code LJM) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K870452 · Biohytech International, Inc. · Immunology device
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Mar 1987
Decision
55d
Days
Class 2
Risk

K870452 is an FDA 510(k) clearance for the SS-DNA EIA DIAGNOSTIC KIT. Classified as Antinuclear Antibody (enzyme-labeled), Antigen, Controls (product code LJM), Class II - Special Controls.

Submitted by Biohytech International, Inc. (Chicago, US). The FDA issued a Cleared decision on March 17, 1987 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5100 - the FDA immunology device 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 Biohytech International, Inc. devices

Submission Details

510(k) Number K870452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1987
Decision Date March 17, 1987
Days to Decision 55 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 104d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5100
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 Immunology devices follow this clearance model.

Regulatory Peers - LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls

All 41
Devices cleared under the same product code (LJM) and FDA review panel - the closest regulatory comparables to K870452.
HEMAGEN ENA [RNP/SM] KIT (EIA METHOD)
K915272 · Hemagen Diagnostics, Inc. · Mar 1992
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K902915 · Diamedix Corp. · Sep 1990
ANTI-SM MICROASSAY
K894894 · Diamedix Corp. · Aug 1989
AMIZYME-ANA TEST KIT
K842532 · Amico Lab, Inc. · Sep 1984
AMIZYME-ANDNA TEST KIT
K842533 · Amico Lab, Inc. · Sep 1984
ENZYME ANA TEST SYSTEM
K833148 · Immuno Concepts, Inc. · Nov 1983