Cleared Traditional

K801963 - CMV TEST KIT

K801963 is an FDA 510(k) clearance for CMV TEST KIT, manufactured by Immuno-Diagnostic Products, Inc.. The device is a Class 2 Microbiology device with product code GQH cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K801963 · Immuno-Diagnostic Products, Inc. · Microbiology device
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Oct 1980
Decision
65d
Days
Class 2
Risk

K801963 is an FDA 510(k) clearance for the CMV TEST KIT. Classified as Antigen, Cf (including Cf Control), Cytomegalovirus (product code GQH), Class II - Special Controls.

Submitted by Immuno-Diagnostic Products, Inc. (Walker, US). The FDA issued a Cleared decision on October 23, 1980 after a review of 65 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 Immuno-Diagnostic Products, Inc. devices

FDA 510(k) Submission Details - K801963

510(k) Number K801963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1980
Decision Date October 23, 1980
Days to Decision 65 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 102d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GQH Device Classification - Class 2, Special Controls

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

All 12
Devices cleared under the same product code (GQH) and FDA review panel - the closest regulatory comparables to K801963.
CYTOMEGALOVIRUS ANTIBODY FLUORO-KIT II
K833089 · Clinical Sciences, Inc. · May 1984
CYTOMEGALOVIRUS ANTIBODY TEST SYSTEM
K811671 · Zeus Scientific, Inc. · Sep 1981
CYTOMEGALO VIRUS & CONTROLS
K802930 · Orion Diagnostica, Inc. · Jan 1981
FIAX TEST KIT FOR ANTI-CYTOMEGALORIRUS
K791948 · Intl. Diagnostic Technology · Nov 1979