Cleared Traditional

K843657 - CYTOMEGALOVIRUS

K843657 is the FDA 510(k) clearance for CYTOMEGALOVIRUS by Institute Virion , Ltd.. It is a Class 2 Microbiology device (product code GQH) cleared through the Traditional 510(k) pathway after a 374-day FDA review.

K843657 · Institute Virion , Ltd. · Microbiology device
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Sep 1985
Decision
374d
Days
Class 2
Risk

K843657 is an FDA 510(k) clearance for the CYTOMEGALOVIRUS. Classified as Antigen, Cf (including Cf Control), Cytomegalovirus (product code GQH), Class II - Special Controls.

Submitted by Institute Virion , Ltd. (Walker, US). The FDA issued a Cleared decision on September 26, 1985 after a review of 374 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Institute Virion , Ltd. devices

Submission Details

510(k) Number K843657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1984
Decision Date September 26, 1985
Days to Decision 374 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
272d slower than avg
Panel avg: 102d · This submission: 374d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GQH Antigen, Cf (including Cf Control), 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 - GQH Antigen, Cf (including Cf Control), Cytomegalovirus

Devices cleared under the same product code (GQH) and FDA review panel - the closest regulatory comparables to K843657.
ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT
K881932 · Ortho Diagnostic Systems, Inc. · Aug 1988
MICROTRAK CMV CULTURE CONFIRMATION TEST
K880290 · Syva Co. · Apr 1988
CYTOMEGALOVIRUS CONTROL SLIDES
K873114 · Medical Diagnostic Technologies, Inc. · Sep 1987
CYTOMEGALOVIRUS ANTIBODY TEST SYSTEM
K811671 · Zeus Scientific, Inc. · Sep 1981