Cleared Traditional

K833089 - CYTOMEGALOVIRUS ANTIBODY FLUORO-KIT II

K833089 is the FDA 510(k) clearance for CYTOMEGALOVIRUS ANTIBODY FLUORO-KIT II by Clinical Sciences, Inc.. It is a Class 2 Microbiology device (product code GQH) cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K833089 · Clinical Sciences, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1984
Decision
233d
Days
Class 2
Risk

K833089 is an FDA 510(k) clearance for the CYTOMEGALOVIRUS ANTIBODY FLUORO-KIT II. Classified as Antigen, Cf (including Cf Control), Cytomegalovirus (product code GQH), Class II - Special Controls.

Submitted by Clinical Sciences, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 2, 1984 after a review of 233 days - an extended review 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: 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 Clinical Sciences, Inc. devices

Submission Details

510(k) Number K833089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1983
Decision Date May 02, 1984
Days to Decision 233 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
131d slower than avg
Panel avg: 102d · This submission: 233d
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 K833089.
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