Cleared Traditional

K003761 - NAT - NUCLEIC ACID TRANSPORT

K003761 is the FDA 510(k) clearance for NAT - NUCLEIC ACID TRANSPORT by Medical Packaging Corp.. It is a Class 1 Microbiology device (product code LIO) cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K003761 · Medical Packaging Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
176d
Days
Class 1
Risk

K003761 is an FDA 510(k) clearance for the NAT - NUCLEIC ACID TRANSPORT. Classified as Device, Specimen Collection (product code LIO), Class I - General Controls.

Submitted by Medical Packaging Corp. (Camarillo, US). The FDA issued a Cleared decision on May 31, 2001 after a review of 176 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 Medical Packaging Corp. devices

Submission Details

510(k) Number K003761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2000
Decision Date May 31, 2001
Days to Decision 176 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
74d slower than avg
Panel avg: 102d · This submission: 176d
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 17
Devices cleared under the same product code (LIO) and FDA review panel - the closest regulatory comparables to K003761.
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MID-STREAM COLLECTION SET-STERILE
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PARA-PAK PLUS
K931770 · Meridian Diagnostics, Inc. · Jun 1993
CYTOQUANT COMBINED TRANSPORT MEDIA
K924053 · Proteins Intl., Inc. · Jan 1993