Cleared Traditional

K875159 - DETECTADOT SYSTEM 2000 CMV IGG TEST

K875159 is an FDA 510(k) clearance for DETECTADOT SYSTEM 2000 CMV IGG TEST, manufactured by Gull Laboratories, Inc.. The device is a Class 2 Microbiology device with product code GQI cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K875159 · Gull Laboratories, Inc. · Microbiology device
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May 1988
Decision
142d
Days
Class 2
Risk

K875159 is an FDA 510(k) clearance for the DETECTADOT SYSTEM 2000 CMV IGG TEST. Classified as Antiserum, Cf, Cytomegalovirus (product code GQI), Class II - Special Controls.

Submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on May 6, 1988 after a review of 142 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K875159

510(k) Number K875159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1987
Decision Date May 06, 1988
Days to Decision 142 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 102d · This submission: 142d
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 17
Devices cleared under the same product code (GQI) and FDA review panel - the closest regulatory comparables to K875159.
ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS
K952254 · Pyramid Biological Corp. · Nov 1995
CMV EARLY ANTIGEN TEST
K942171 · Neogenex · Jun 1994
VIRGO (R) CMV-IGG ELISA
K883102 · Electro-Nucleonics, Inc. · Feb 1989
ENZYGNOST ANTI-CMV IGG TEST
K863488 · Behring Diagnostics, Inc. · Jul 1987
THE GOLDEN QUAD TEST (CMV)
K861123 · Microbiological Research Corp. · Feb 1987
CMV MICROASSAY
K864420 · Diamedix Corp. · Feb 1987
K875159 · DETECTADOT SYSTEM 2000 CMV IGG TEST
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