Cleared Traditional

PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM (K131630) - FDA 510(k) Clearance

Class I Microbiology device.

K131630 · Puritan Medical Products, LLC · Microbiology device
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Oct 2013
Decision
139d
Days
Class 1
Risk

K131630 is an FDA 510(k) clearance for the PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM. Classified as Device, Specimen Collection (product code LIO), Class I - General Controls.

Submitted by Puritan Medical Products, LLC (Guilford, US). The FDA issued a Cleared decision on October 21, 2013 after a review of 139 days - within the typical 510(k) review window.

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 Puritan Medical Products, LLC devices

Submission Details

510(k) Number K131630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2013
Decision Date October 21, 2013
Days to Decision 139 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
37d slower than avg
Panel avg: 102d · This submission: 139d
Pathway characteristics
Predicate-based equivalence.

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.

Regulatory Peers - LIO Device, Specimen Collection

All 11
Devices cleared under the same product code (LIO) and FDA review panel - the closest regulatory comparables to K131630.
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PATHODX(TM) CHLAMYDIA DIRECT SPECIMEN (PDCY1)
K893905 · Diagnostic Products Corp. · Aug 1989