Cleared Traditional

K010301 - IMMUNOWELL EA (D) IGG TEST

K010301 is an FDA 510(k) clearance for IMMUNOWELL EA (D) IGG TEST, manufactured by Genbio. The device is a Class 1 Microbiology device with product code LSE cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K010301 · Genbio · Microbiology device
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Jun 2001
Decision
130d
Days
Class 1
Risk

K010301 is an FDA 510(k) clearance for the IMMUNOWELL EA (D) IGG TEST. Classified as Epstein-barr Virus, Other (product code LSE), Class I - General Controls.

Submitted by Genbio (San Diego, US). The FDA issued a Cleared decision on June 11, 2001 after a review of 130 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 Genbio devices

FDA 510(k) Submission Details - K010301

510(k) Number K010301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2001
Decision Date June 11, 2001
Days to Decision 130 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
28d slower than avg
Panel avg: 102d · This submission: 130d
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 K010301.
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