Cleared Traditional

K981812 - EBV-VCA IGG ELISA TEST SYSTEM

K981812 is an FDA 510(k) clearance for EBV-VCA IGG ELISA TEST SYSTEM, manufactured by Diamedix Corp.. The device is a Class 1 Microbiology device with product code LSE cleared through the Traditional 510(k) pathway after a 286-day FDA review.

K981812 · Diamedix Corp. · Microbiology device
Download Printable Device Report (PDF)
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Mar 1999
Decision
286d
Days
Class 1
Risk

K981812 is an FDA 510(k) clearance for the EBV-VCA IGG ELISA TEST SYSTEM. Classified as Epstein-barr Virus, Other (product code LSE), Class I - General Controls.

Submitted by Diamedix Corp. (Columbia, US). The FDA issued a Cleared decision on March 4, 1999 after a review of 286 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3235 - 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 Diamedix Corp. devices

FDA 510(k) Submission Details - K981812

510(k) Number K981812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1998
Decision Date March 04, 1999
Days to Decision 286 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
184d slower than avg
Panel avg: 102d · This submission: 286d
Pathway characteristics
Predicate-based equivalence.

LSE Device Classification - Class 1, General Controls

Product Code LSE Epstein-barr Virus, Other
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3235
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LSE Epstein-barr Virus, Other

All 47
Devices cleared under the same product code (LSE) and FDA review panel - the closest regulatory comparables to K981812.
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COPALIS MULTIPLEX EBV ANTIBODY ASSAY
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THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO
K983801 · Zeus Scientific, Inc. · Dec 1998
THE APTUS (AUTOMATED) APPLICATION OF THE EBV-EA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
K983804 · Zeus Scientific, Inc. · Dec 1998
EBNA-1 IGM ELISA TEST SYSTEM
K982348 · Columbia Bioscience, Inc. · Nov 1998