Cleared Traditional

K992191 - ETI-EA-G ASSAY

K992191 is the FDA 510(k) clearance for ETI-EA-G ASSAY by DiaSorin, Inc.. It is a Class 1 Microbiology device (product code LSE) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K992191 · DiaSorin, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
14d
Days
Class 1
Risk

K992191 is an FDA 510(k) clearance for the ETI-EA-G ASSAY. Classified as Epstein-barr Virus, Other (product code LSE), Class I - General Controls.

Submitted by DiaSorin, Inc. (Columbia, US). The FDA issued a Cleared decision on July 12, 1999 after a review of 14 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 DiaSorin, Inc. devices

Submission Details

510(k) Number K992191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1999
Decision Date July 12, 1999
Days to Decision 14 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 102d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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.

Regulatory Consultant

Tuv Product Service, Inc.
CAROLE STAMP

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LSE Epstein-barr Virus, Other

All 23
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K983801 · Zeus Scientific, Inc. · Dec 1998