Cleared Traditional

K980912 - VCA IGG ELISA TEST SYSTEM

K980912 is an FDA 510(k) clearance for VCA IGG ELISA TEST SYSTEM, manufactured by Clark Laboratories, Inc.. The device is a Class 1 Microbiology device with product code LSE cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K980912 · Clark Laboratories, Inc. · Microbiology device
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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

FDA 510(k) Submission Details - K980912

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 102d · This submission: 134d
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 46
Devices cleared under the same product code (LSE) and FDA review panel - the closest regulatory comparables to K980912.
ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISA
K981120 · Zeus Scientific, Inc. · Aug 1998
IMMUNOWELL EBV VCA IGG TEST
K973940 · Genbio · Aug 1998
VCA IGM ELISA TEST SYSTEM
K980596 · Clark Laboratories, Inc. · Jul 1998
EA-D IGG ELISA TEST SYSTEM
K973123 · Clark Laboratories, Inc. · Mar 1998
EBV-VCA IGM ELISA TEST STSTEM
K944449 · Zeus Scientific, Inc. · Sep 1995
EBV-EA(D) IGG ELISA TEST
K940093 · Gull Laboratories, Inc. · Sep 1995