Cleared Traditional

K900796 - CMV IGG ELISA TEST

K900796 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 71-day FDA review.

K900796 · Gull Laboratories, Inc. · Microbiology device
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May 1990
Decision
71d
Days
Class 2
Risk

K900796 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 May 2, 1990 after a review of 71 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 K900796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1990
Decision Date May 02, 1990
Days to Decision 71 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
31d faster than avg
Panel avg: 102d · This submission: 71d
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 K900796.
ORTHO CMV-G ANTIBODY ELISA TEST
K905078 · Ortho Diagnostic Systems, Inc. · Dec 1990
IMX CMV IGM ANTIBODY ASSAY
K900473 · Abbott Laboratories · Jul 1990
IMX CMV IGG ANTIBODY ASSAY
K900474 · Abbott Laboratories · Jul 1990
CMV IGM ELISA TEST SYSTEM
K896355 · Zeus Scientific, Inc. · Feb 1990
DETECTADOT TM SYSTEM 2000 CMV IGM TEST
K893230 · Gull Laboratories, Inc. · Dec 1989
VIRONOSTIKA(TM) ANTI-CMV IGM MICROELISA SYSTEM
K890610 · Organon Teknika Corp. · Jun 1989