Cleared Traditional

K884246 - MODIFIED DDI SEROCARD HERPES IGG TEST KIT

K884246 is the FDA 510(k) clearance for MODIFIED DDI SEROCARD HERPES IGG TEST KIT by Disease Detection International, Inc.. It is a Class 2 Microbiology device (product code LGC) cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K884246 · Disease Detection International, Inc. · Microbiology device
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Apr 1989
Decision
181d
Days
Class 2
Risk

K884246 is an FDA 510(k) clearance for the MODIFIED DDI SEROCARD HERPES IGG TEST KIT. Classified as Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific (product code LGC), Class II - Special Controls.

Submitted by Disease Detection International, Inc. (Irvine, US). The FDA issued a Cleared decision on April 10, 1989 after a review of 181 days - an extended review 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: 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 Disease Detection International, Inc. devices

Submission Details

510(k) Number K884246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1988
Decision Date April 10, 1989
Days to Decision 181 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 102d · This submission: 181d
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 28
Devices cleared under the same product code (LGC) and FDA review panel - the closest regulatory comparables to K884246.
IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS
K910499 · Vitek Systems, Inc. · May 1991
KODAK SURECELL HERPES (HSV) CONTROL FLUID SET
K903926 · Eastman Kodak Company · Sep 1990
HERPTRAN CONCENTRATE
K900713 · E.I. Dupont DE Nemours & Co., Inc. · May 1990
KODAK SURECELL HERPES (HSV) TEST KIT
K884680 · Eastman Kodak Company · Feb 1989
ABBOTT HSV EIA
K843622 · Abbott Laboratories · May 1985
HSV ANTIGEN ELISA KIT
K834449 · Ortho Diagnostic Systems, Inc. · May 1984