Cleared Traditional

ZYGOTEK MICROCOMPUTERIZED SEMEN ANALYSIS SYSTEM (K861773) - FDA 510(k) Clearance

Class I Immunology device.

K861773 · Zygotek Systems, Inc. · Immunology device
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Jul 1986
Decision
61d
Days
Class 1
Risk

K861773 is an FDA 510(k) clearance for the ZYGOTEK MICROCOMPUTERIZED SEMEN ANALYSIS SYSTEM. Classified as Seminal Fluid, Antigen, Antiserum, Control (product code DGB), Class I - General Controls.

Submitted by Zygotek Systems, Inc. (Springfield, US). The FDA issued a Cleared decision on July 7, 1986 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5800 - 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 Zygotek Systems, Inc. devices

Submission Details

510(k) Number K861773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1986
Decision Date July 07, 1986
Days to Decision 61 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 104d · This submission: 61d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DGB Seminal Fluid, Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5800
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.