Cleared Traditional

EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA (K921628) - FDA 510(k) Clearance

Class I Microbiology device.

K921628 · Incstar Corp. · Microbiology device
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Sep 1992
Decision
161d
Days
Class 1
Risk

K921628 is an FDA 510(k) clearance for the EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA. Classified as Epstein-barr Virus, Other (product code LSE), Class I - General Controls.

Submitted by Incstar Corp. (Stillwater, US). The FDA issued a Cleared decision on September 14, 1992 after a review of 161 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 Incstar Corp. devices

Submission Details

510(k) Number K921628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1992
Decision Date September 14, 1992
Days to Decision 161 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
59d slower than avg
Panel avg: 102d · This submission: 161d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.