Cleared Traditional

K021793 - EBV EA-D IGG ELISA KIT, MODEL EBG-100

K021793 is an FDA 510(k) clearance for EBV EA-D IGG ELISA KIT, manufactured by Pan Bio Pty. , Ltd.. The device is a Class 1 Microbiology device with product code LSE cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K021793 · Pan Bio Pty. , Ltd. · Microbiology device
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Sep 2002
Decision
119d
Days
Class 1
Risk

K021793 is an FDA 510(k) clearance for the EBV EA-D IGG ELISA KIT, MODEL EBG-100. Classified as Epstein-barr Virus, Other (product code LSE), Class I - General Controls.

Submitted by Pan Bio Pty. , Ltd. (Brisbane, Queensland, AU). The FDA issued a Cleared decision on September 27, 2002 after a review of 119 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 Pan Bio Pty. , Ltd. devices

FDA 510(k) Submission Details - K021793

510(k) Number K021793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2002
Decision Date September 27, 2002
Days to Decision 119 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 102d · This submission: 119d
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 48
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