Cleared Traditional

K910953 - HSV-2 IGM ELISA TEST

K910953 is the FDA 510(k) clearance for HSV-2 IGM ELISA TEST by Gull Laboratories, Inc.. It is a Class 2 Microbiology device (product code LGC) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K910953 · Gull Laboratories, Inc. · Microbiology device
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May 1991
Decision
82d
Days
Class 2
Risk

K910953 is an FDA 510(k) clearance for the HSV-2 IGM 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 82 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 K910953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1991
Decision Date May 28, 1991
Days to Decision 82 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
20d faster than avg
Panel avg: 102d · This submission: 82d
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 27
Devices cleared under the same product code (LGC) and FDA review panel - the closest regulatory comparables to K910953.
BARTELS HERPES SIMPLEX VIRUS 1 IGG EIA
K922584 · Baxter Diagnostics, Inc. · Sep 1992
ORTHO HSV ANTIGEN ELISA TEST
K915551 · Ortho Diagnostic Systems, Inc. · Apr 1992
HSV-2 IGG ELISA TEST
K910952 · Gull Laboratories, Inc. · May 1991
HSV-1 IGG ELISA TEST
K910954 · Gull Laboratories, Inc. · May 1991
HSV-1 IGM ELISA TEST
K910955 · Gull Laboratories, Inc. · May 1991
IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS
K910499 · Vitek Systems, Inc. · May 1991