Cleared Traditional

K862705 - CYTOMEGALOVIRUS IGG EIA TEST KIT

K862705 is the FDA 510(k) clearance for CYTOMEGALOVIRUS IGG EIA TEST KIT by Labsystems, Inc.. It is a Class 2 Microbiology device (product code GQI) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K862705 · Labsystems, Inc. · Microbiology device
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Oct 1986
Decision
77d
Days
Class 2
Risk

K862705 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. (Chicago, US). The FDA issued a Cleared decision on October 1, 1986 after a review of 77 days - a notably fast clearance cycle.

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

Submission Details

510(k) Number K862705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1986
Decision Date October 01, 1986
Days to Decision 77 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 102d · This submission: 77d
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 Microbiology devices follow this clearance model.

Regulatory Peers - GQI Antiserum, Cf, Cytomegalovirus

Devices cleared under the same product code (GQI) and FDA review panel - the closest regulatory comparables to K862705.
DETECTADOT SYSTEM 2000 CMV IGG TEST
K875159 · Gull Laboratories, Inc. · May 1988
ENZYGNOST ANTI-CMV IGG TEST
K863488 · Behring Diagnostics, Inc. · Jul 1987
CMV MICROASSAY
K864420 · Diamedix Corp. · Feb 1987
COR DOT CMV
K853989 · Cordis Corp. · Jun 1986
CMV TEST
K853137 · Gull Laboratories, Inc. · Nov 1985
CMV CF ANTIGEN
K853277 · Hillcrest Biologicals · Nov 1985