Cleared Traditional

K862838 - CYTOTECH HSV IGG ENZYME IMMUNOASSAY

K862838 is an FDA 510(k) clearance for CYTOTECH HSV IGG ENZYME IMMUNOASSAY, manufactured by Cytotech, Inc.. The device is a Class 2 Microbiology device with product code GCO cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K862838 · Cytotech, Inc. · Microbiology device
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Dec 1986
Decision
137d
Days
Class 2
Risk

K862838 is an FDA 510(k) clearance for the CYTOTECH HSV IGG ENZYME IMMUNOASSAY. Classified as Endoscope, Mirror (product code GCO), Class II - Special Controls.

Submitted by Cytotech, Inc. (San Diego, US). The FDA issued a Cleared decision on December 9, 1986 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 876.1500 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cytotech, Inc. devices

FDA 510(k) Submission Details - K862838

510(k) Number K862838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1986
Decision Date December 09, 1986
Days to Decision 137 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 102d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCO Device Classification - Class 2, Special Controls

Product Code GCO Endoscope, Mirror
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 Microbiology devices follow this clearance model.