Cleared Traditional

VCA IGG ELISA TEST SYSTEM (K980912) - FDA 510(k) Clearance

Class I Microbiology device.

K980912 · Clark Laboratories, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
134d
Days
Class 1
Risk

K980912 is an FDA 510(k) clearance for the VCA IGG ELISA TEST SYSTEM. Classified as Epstein-barr Virus, Other (product code LSE), Class I - General Controls.

Submitted by Clark Laboratories, Inc. (Frederick, US). The FDA issued a Cleared decision on July 22, 1998 after a review of 134 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 Clark Laboratories, Inc. devices

Submission Details

510(k) Number K980912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1998
Decision Date July 22, 1998
Days to Decision 134 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
32d slower than avg
Panel avg: 102d · This submission: 134d
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.