Cleared Traditional

K884246 - MODIFIED DDI SEROCARD HERPES IGG TEST KIT

K884246 is an FDA 510(k) clearance for MODIFIED DDI SEROCARD HERPES IGG TEST KIT, manufactured by Disease Detection International, Inc.. The device is a Class 2 Microbiology device with 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

FDA 510(k) Submission Details - K884246

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
Combination Product No
PCCP Authorized No
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.

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 K884246.
SEROCARD HSV IGG ANTIBODY TEST KIT
K903070 · Disease Detection International, Inc. · Aug 1990
HERPTRAN CONCENTRATE
K900713 · E.I. Dupont DE Nemours & Co., Inc. · May 1990
IDEIA HERPES SIMPLEX VIRUS TEST
K871877 · Boots-Celltech Diagnostics, Inc. · Nov 1989
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