Cleared Traditional

K922584 - BARTELS HERPES SIMPLEX VIRUS 1 IGG EIA

K922584 is an FDA 510(k) clearance for BARTELS HERPES SIMPLEX VIRUS 1 IGG EIA, manufactured by Baxter Diagnostics, Inc.. The device is a Class 2 Microbiology device with product code LGC cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K922584 · Baxter Diagnostics, Inc. · Microbiology device
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Sep 1992
Decision
114d
Days
Class 2
Risk

K922584 is an FDA 510(k) clearance for the BARTELS HERPES SIMPLEX VIRUS 1 IGG EIA. Classified as Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific (product code LGC), Class II - Special Controls.

Submitted by Baxter Diagnostics, Inc. (Bellevue, US). The FDA issued a Cleared decision on September 18, 1992 after a review of 114 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 Baxter Diagnostics, Inc. devices

FDA 510(k) Submission Details - K922584

510(k) Number K922584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1992
Decision Date September 18, 1992
Days to Decision 114 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 102d · This submission: 114d
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 K922584.
HSV-1 IGM ELISA TEST -- MODIFICATION
K922758 · Gull Laboratories, Inc. · Oct 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
ORTHO HSV ANTIGEN ELISA TEST
K915551 · Ortho Diagnostic Systems, Inc. · Apr 1992
HSV-2 IGG ELISA TEST
K910952 · Gull Laboratories, Inc. · May 1991
HSV-2 IGM ELISA TEST
K910953 · Gull Laboratories, Inc. · May 1991