Cleared Traditional

K003761 - NAT - NUCLEIC ACID TRANSPORT

K003761 is an FDA 510(k) clearance for NAT - NUCLEIC ACID TRANSPORT, manufactured by Medical Packaging Corp.. The device is a Class 1 Microbiology device with 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

FDA 510(k) Submission Details - K003761

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.

LIO Device Classification - Class 1, General Controls

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 35
Devices cleared under the same product code (LIO) and FDA review panel - the closest regulatory comparables to K003761.
MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE
K103805 · Medical Wire & Equipment Company (Bath), Ltd. · Jan 2011
COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE
K070062 · Diesse Diagnostica Senese S.P.A. · Jul 2007
BACTI-SWAB DRY
K013711 · Remel Co. · Nov 2001
ENTERO-TEST HP, MODEL #102-01
K983119 · Hdc Corp. · Mar 1999
PAR-ONE
K981391 · Remel, Inc. · Jul 1998
PARACON PLUS FORMALIN - PCP-F, PARACON PLUS SAF - PCP-SAF AND PARACON PLUS MF - PCP-MF
K964144 · Para Scientific Co. · Nov 1996