Cleared Traditional

K915551 - ORTHO HSV ANTIGEN ELISA TEST

K915551 is the FDA 510(k) clearance for ORTHO HSV ANTIGEN ELISA TEST by Ortho Diagnostic Systems, Inc.. It is a Class 2 Microbiology device (product code LGC) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K915551 · Ortho Diagnostic Systems, Inc. · Microbiology device
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Apr 1992
Decision
133d
Days
Class 2
Risk

K915551 is an FDA 510(k) clearance for the ORTHO HSV ANTIGEN ELISA TEST. Classified as Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific (product code LGC), Class II - Special Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Carpinteria, US). The FDA issued a Cleared decision on April 22, 1992 after a review of 133 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 Ortho Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K915551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1991
Decision Date April 22, 1992
Days to Decision 133 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
31d slower than avg
Panel avg: 102d · This submission: 133d
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 K915551.
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
HSV-2 IGG ELISA TEST
K910952 · Gull Laboratories, Inc. · May 1991
HSV-2 IGM ELISA TEST
K910953 · Gull Laboratories, Inc. · May 1991
HSV-1 IGG ELISA TEST
K910954 · Gull Laboratories, Inc. · May 1991