Cleared Traditional

K903807 - CMV IGM ELISA TEST

K903807 is the FDA 510(k) clearance for CMV IGM 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 119-day FDA review.

K903807 · Gull Laboratories, Inc. · Microbiology device
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Dec 1990
Decision
119d
Days
Class 2
Risk

K903807 is an FDA 510(k) clearance for the CMV IGM 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 December 17, 1990 after a review of 119 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.

View all Gull Laboratories, Inc. devices

Submission Details

510(k) Number K903807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1990
Decision Date December 17, 1990
Days to Decision 119 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
17d slower than avg
Panel avg: 102d · This submission: 119d
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 K903807.
ENZYGNOST(R) ANTI-CMV/IGM
K913693 · Behring Diagnostics, Inc. · Feb 1992
CMV IGG ELISA TEST
K915892 · Gull Laboratories, Inc. · Feb 1992
ENZYGNOST ANTI-CMV/IGG + IGM
K901485 · Behring Diagnostics, Inc. · May 1991
ORTHO CMV-M ANTIBODY ELISA TEST
K905077 · Ortho Diagnostic Systems, Inc. · Dec 1990
ORTHO CMV-G ANTIBODY ELISA TEST
K905078 · Ortho Diagnostic Systems, Inc. · Dec 1990
IMX CMV IGM ANTIBODY ASSAY
K900473 · Abbott Laboratories · Jul 1990