Cleared Traditional

K984346 - PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST

K984346 is an FDA 510(k) clearance for PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST, manufactured by Meridian Diagnostics, Inc.. The device is a Class 2 Microbiology device with product code LGC cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K984346 · Meridian Diagnostics, Inc. · Microbiology device
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Jun 1999
Decision
203d
Days
Class 2
Risk

K984346 is an FDA 510(k) clearance for the PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST. Classified as Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific (product code LGC), Class II - Special Controls.

Submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on June 25, 1999 after a review of 203 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 Meridian Diagnostics, Inc. devices

FDA 510(k) Submission Details - K984346

510(k) Number K984346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1998
Decision Date June 25, 1999
Days to Decision 203 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
101d slower than avg
Panel avg: 102d · This submission: 203d
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 K984346.
DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM
K002262 · Diamedix Corp. · Nov 2000
THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
K992166 · Zeus Scientific, Inc. · Sep 1999
POCKIT HSV 2 RAPID TEST
K983886 · Diagnology , Ltd. · Aug 1999
HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM
K983656 · Zeus Scientific, Inc. · Mar 1999
HSV 1+2 IGG ELISA TEST
K983541 · Gull Laboratories, Inc. · Feb 1999
DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM
K981306 · Diamedix Corp. · Sep 1998