Cleared Traditional

K926114 - HEP-2 ANTINUCLEAR ANTIBODY TEST SYSTEM

K926114 is an FDA 510(k) clearance for HEP-2 ANTINUCLEAR ANTIBODY TEST SYSTEM, manufactured by Tissue Culture Biotec, Inc.. The device is a Class 2 Immunology device with product code DHN cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K926114 · Tissue Culture Biotec, Inc. · Immunology device
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May 1993
Decision
168d
Days
Class 2
Risk

K926114 is an FDA 510(k) clearance for the HEP-2 ANTINUCLEAR ANTIBODY TEST SYSTEM. Classified as Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (product code DHN), Class II - Special Controls.

Submitted by Tissue Culture Biotec, Inc. (Bozeman, US). The FDA issued a Cleared decision on May 20, 1993 after a review of 168 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Tissue Culture Biotec, Inc. devices

FDA 510(k) Submission Details - K926114

510(k) Number K926114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1992
Decision Date May 20, 1993
Days to Decision 168 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 105d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHN Device Classification - Class 2, Special Controls

Product Code DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
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 - DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

All 72
Devices cleared under the same product code (DHN) and FDA review panel - the closest regulatory comparables to K926114.
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