Cleared Traditional

K922758 - HSV-1 IGM ELISA TEST -- MODIFICATION

K922758 is the FDA 510(k) clearance for HSV-1 IGM ELISA TEST -- MODIFICATION by Gull Laboratories, Inc.. It is a Class 2 Microbiology device (product code LGC) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K922758 · Gull Laboratories, Inc. · Microbiology device
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Oct 1992
Decision
119d
Days
Class 2
Risk

K922758 is an FDA 510(k) clearance for the HSV-1 IGM ELISA TEST -- MODIFICATION. 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 October 5, 1992 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 866.3305 - 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: 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 K922758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1992
Decision Date October 05, 1992
Days to Decision 119 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
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 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 K922758.
ORTHO HSV ANTIGEN ELISA TEST, MODIFICATION
K925208 · Ortho Diagnostic Systems, Inc. · Dec 1992
BARTELS HERPES SIMPLEX VIRUS 2 IGM EIA
K922333 · Baxter Diagnostics, Inc. · Dec 1992
BARTELS HERPES SIMPLEX VIRUS 1 IGM EIA
K922334 · Baxter Diagnostics, Inc. · Dec 1992
HSV-2 IGM ELISA TEST--MODIFICATION
K922759 · Gull Laboratories, Inc. · Oct 1992
BARTELS HERPES SIMPLEX VIRUS 2 IGG EIA
K922583 · Baxter Diagnostics, Inc. · Sep 1992
BARTELS HERPES SIMPLEX VIRUS 1 IGG EIA
K922584 · Baxter Diagnostics, Inc. · Sep 1992