Cleared Traditional

K982348 - EBNA-1 IGM ELISA TEST SYSTEM

K982348 is an FDA 510(k) clearance for EBNA-1 IGM ELISA TEST SYSTEM, manufactured by Columbia Bioscience, Inc.. The device is a Class 1 Microbiology device with product code LSE cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K982348 · Columbia Bioscience, Inc. · Microbiology device
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Nov 1998
Decision
142d
Days
Class 1
Risk

K982348 is an FDA 510(k) clearance for the EBNA-1 IGM ELISA TEST SYSTEM. Classified as Epstein-barr Virus, Other (product code LSE), Class I - General Controls.

Submitted by Columbia Bioscience, Inc. (Columbia, US). The FDA issued a Cleared decision on November 25, 1998 after a review of 142 days - within the typical 510(k) review window.

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 Columbia Bioscience, Inc. devices

FDA 510(k) Submission Details - K982348

510(k) Number K982348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1998
Decision Date November 25, 1998
Days to Decision 142 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
40d slower than avg
Panel avg: 102d · This submission: 142d
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 46
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