Cleared Traditional

CYTOMEGALOVIRUS IGG EIA TEST KIT (K843189) - FDA 510(k) Clearance

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

K843189 · Labsystems, Inc. · Immunology device
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Jan 1986
Decision
513d
Days
Class 2
Risk

K843189 is an FDA 510(k) clearance for the CYTOMEGALOVIRUS IGG EIA TEST KIT. Classified as Antiserum, Cf, Cytomegalovirus (product code GQI), Class II - Special Controls.

Submitted by Labsystems, Inc.. The FDA issued a Cleared decision on January 8, 1986 after a review of 513 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3175 - 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 Labsystems, Inc. devices

Submission Details

510(k) Number K843189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1984
Decision Date January 08, 1986
Days to Decision 513 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
409d slower than avg
Panel avg: 104d · This submission: 513d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GQI Antiserum, Cf, Cytomegalovirus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3175
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.