Cleared Traditional

COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE (K070062) - FDA 510(k) Clearance

Class I Microbiology device.

K070062 · Diesse Diagnostica Senese S.P.A. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
206d
Days
Class 1
Risk

K070062 is an FDA 510(k) clearance for the COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENE.... Classified as Device, Specimen Collection (product code LIO), Class I - General Controls.

Submitted by Diesse Diagnostica Senese S.P.A. (Hialeah, US). The FDA issued a Cleared decision on July 30, 2007 after a review of 206 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2900 - 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 Diesse Diagnostica Senese S.P.A. devices

Submission Details

510(k) Number K070062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2007
Decision Date July 30, 2007
Days to Decision 206 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 102d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

Device Classification

Product Code LIO Device, Specimen Collection
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2900
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.

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