Cleared Traditional

K952254 - ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS

K952254 is an FDA 510(k) clearance for ENZYME LINKED IMMUNOABSORBENT ASSAY, manufactured by Pyramid Biological Corp.. The device is a Class 2 Microbiology device with product code GQI cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K952254 · Pyramid Biological Corp. · Microbiology device
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Nov 1995
Decision
185d
Days
Class 2
Risk

K952254 is an FDA 510(k) clearance for the ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS. Classified as Antiserum, Cf, Cytomegalovirus (product code GQI), Class II - Special Controls.

Submitted by Pyramid Biological Corp. (Van Nuys, US). The FDA issued a Cleared decision on November 16, 1995 after a review of 185 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 Pyramid Biological Corp. devices

FDA 510(k) Submission Details - K952254

510(k) Number K952254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1995
Decision Date November 16, 1995
Days to Decision 185 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 102d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GQI Device Classification - Class 2, Special Controls

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

All 12
Devices cleared under the same product code (GQI) and FDA review panel - the closest regulatory comparables to K952254.
CMV EARLY ANTIGEN TEST
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ENZYGNOST ANTI-CMV IGG TEST
K863488 · Behring Diagnostics, Inc. · Jul 1987
CMV MICROASSAY
K864420 · Diamedix Corp. · Feb 1987
CYTOMEGALOVIRUS IGG EIA TEST KIT
K862705 · Labsystems, Inc. · Oct 1986
COR DOT CMV
K853989 · Cordis Corp. · Jun 1986