Cleared Traditional

ENZYGNOST ANTIHERPES SIMPLEX VIRUS (K841245) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K841245 · Behring Diagnostics, Inc. · Immunology device
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Nov 1985
Decision
592d
Days
Class 2
Risk

K841245 is an FDA 510(k) clearance for the ENZYGNOST ANTIHERPES SIMPLEX VIRUS. Classified as Antisera, Cf, Herpesvirus Hominis 1,2 (product code GQO), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (La Jolla, US). The FDA issued a Cleared decision on November 5, 1985 after a review of 592 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3305 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Immunology submissions.

View all Behring Diagnostics, Inc. devices

Submission Details

510(k) Number K841245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1984
Decision Date November 05, 1985
Days to Decision 592 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
488d slower than avg
Panel avg: 104d · This submission: 592d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GQO Antisera, Cf, Herpesvirus Hominis 1,2
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3305
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.