Cleared Traditional

HSV-1 IGG ELISA TEST (K910954) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K910954 · Gull Laboratories, Inc. · Microbiology device
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May 1991
Decision
83d
Days
Class 2
Risk

K910954 is an FDA 510(k) clearance for the HSV-1 IGG ELISA TEST. Classified as Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific (product code LGC), Class II - Special Controls.

Submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on May 28, 1991 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3305 - 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 K910954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1991
Decision Date May 28, 1991
Days to Decision 83 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 102d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3305
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 - LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific

All 37
Devices cleared under the same product code (LGC) and FDA review panel - the closest regulatory comparables to K910954.
MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6
K010878 · Diagnostic Products Corp. · Apr 2001
IMMULITE HERPES I AND II IGG
K950670 · Diagnostic Products Corp. · Jun 1996
KODAK SURECELL HERPES (HSV) CONTROL FLUID SET
K903926 · Eastman Kodak Company · Sep 1990
HERPTRAN CONCENTRATE
K900713 · E.I. Dupont DE Nemours & Co., Inc. · May 1990
KODAK SURECELL HERPES (HSV) TEST KIT
K884680 · Eastman Kodak Company · Feb 1989
ABBOTT HSV EIA
K843622 · Abbott Laboratories · May 1985