Cleared Traditional

K915892 - CMV IGG ELISA TEST

K915892 is the FDA 510(k) clearance for CMV IGG ELISA TEST by Gull Laboratories, Inc.. It is a Class 2 Microbiology device (product code LFZ) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K915892 · Gull Laboratories, Inc. · Microbiology device
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Feb 1992
Decision
52d
Days
Class 2
Risk

K915892 is an FDA 510(k) clearance for the CMV IGG ELISA TEST. Classified as Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (product code LFZ), Class II - Special Controls.

Submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on February 14, 1992 after a review of 52 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 Gull Laboratories, Inc. devices

Submission Details

510(k) Number K915892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1991
Decision Date February 14, 1992
Days to Decision 52 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 102d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LFZ Enzyme Linked Immunoabsorbent Assay, 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 - LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

All 42
Devices cleared under the same product code (LFZ) and FDA review panel - the closest regulatory comparables to K915892.
VIDAS CMV IGG ASSAY
K920661 · Vitek Systems, Inc. · Feb 1993
ENZYGNOST(R) ANTI-CMV IGG
K913910 · Behring Diagnostics, Inc. · Apr 1992
ENZYGNOST(R) ANTI-CMV/IGM
K913693 · Behring Diagnostics, Inc. · Feb 1992
ENZYGNOST ANTI-CMV/IGG + IGM
K901485 · Behring Diagnostics, Inc. · May 1991
CMV IGM ELISA TEST
K903807 · Gull Laboratories, Inc. · Dec 1990
ORTHO CMV-M ANTIBODY ELISA TEST
K905077 · Ortho Diagnostic Systems, Inc. · Dec 1990