Cleared Traditional

K922758 - HSV-1 IGM ELISA TEST -- MODIFICATION

K922758 is an FDA 510(k) clearance for HSV-1 IGM ELISA TEST -- MODIFICATION, manufactured by Gull Laboratories, Inc.. The device is a Class 2 Microbiology device with 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

FDA 510(k) Submission Details - K922758

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.

LGC Device Classification - Class 2, Special Controls

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 32
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