Cleared Traditional

K980596 - VCA IGM ELISA TEST SYSTEM

K980596 is an FDA 510(k) clearance for VCA IGM 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 155-day FDA review.

K980596 · Clark Laboratories, Inc. · Microbiology device
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Jul 1998
Decision
155d
Days
Class 1
Risk

K980596 is an FDA 510(k) clearance for the VCA IGM 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 155 days - an extended review 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: 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 - K980596

510(k) Number K980596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1998
Decision Date July 22, 1998
Days to Decision 155 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
53d slower than avg
Panel avg: 102d · This submission: 155d
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 K980596.
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VCA IGG ELISA TEST SYSTEM
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EBV-VCA IGM ELISA TEST STSTEM
K944449 · Zeus Scientific, Inc. · Sep 1995