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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 56
Devices cleared under the same product code (LSE) and FDA review panel - the closest regulatory comparables to K010301.
MODIFICATION TO SERAQUEST EB VCA IGG
K033915 · Quest Intl., Inc. · Jan 2004
EBV VCA-P18 IGG ELISA
K030863 · Panbio Limited · Jun 2003
EBV EA-D IGG ELISA KIT, MODEL EBG-100
K021793 · Pan Bio Pty. , Ltd. · Sep 2002
EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM
K992587 · Stellar Bio Systems, Inc. · Dec 1999
SERAQUEST EB NA IGG
K991975 · Quest Intl., Inc. · Nov 1999
SERAQUEST EB VCA IGG
K990410 · Quest Intl., Inc. · Oct 1999
K010301 · IMMUNOWELL EA (D) IGG TEST
Download PDF FDA Summary Genbio