Cleared Traditional

K980598 - EBNA-1 IGM ELISA TEST SYSTEM

K980598 is an FDA 510(k) clearance for EBNA-1 IGM ELISA TEST SYSTEM, manufactured by Clark Laboratories, Inc.. The device is a Class 1 Microbiology device with product code LLM cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K980598 · Clark Laboratories, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
73d
Days
Class 1
Risk

K980598 is an FDA 510(k) clearance for the EBNA-1 IGM ELISA TEST SYSTEM. Classified as Test, Antigen, Nuclear, Epstein-barr Virus (product code LLM), Class I - General Controls.

Submitted by Clark Laboratories, Inc. (Frederick, US). The FDA issued a Cleared decision on May 1, 1998 after a review of 73 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Clark Laboratories, Inc. devices

FDA 510(k) Submission Details - K980598

510(k) Number K980598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1998
Decision Date May 01, 1998
Days to Decision 73 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
29d faster than avg
Panel avg: 102d · This submission: 73d
Pathway characteristics
Predicate-based equivalence.

LLM Device Classification - Class 1, General Controls

Product Code LLM Test, Antigen, Nuclear, Epstein-barr Virus
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 - LLM Test, Antigen, Nuclear, Epstein-barr Virus

All 19
Devices cleared under the same product code (LLM) and FDA review panel - the closest regulatory comparables to K980598.
DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS
K040120 · DiaSorin, Inc. · Apr 2005
THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH
K984133 · Zeus Scientific, Inc. · Jan 1999
IMMUNOWELL EBNA IGG TEST
K973941 · Genbio · Aug 1998
EBNA IGG ELISA TEST
K935730 · Gull Laboratories, Inc. · Sep 1995
INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT
K946158 · Incstar Corp. · Jun 1995
EBNA IGG ELISA TEST SYSTEM
K932742 · Zeus Scientific, Inc. · May 1995