Cleared Traditional

K903807 - CMV IGM ELISA TEST

K903807 is an FDA 510(k) clearance for CMV IGM ELISA TEST, manufactured by Gull Laboratories, Inc.. The device is a Class 2 Microbiology device with 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

FDA 510(k) Submission Details - K903807

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.

LFZ Device Classification - Class 2, Special Controls

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 50
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