Cleared Traditional

MULTIPLE (IZON DNA BLOOD COLLECTION KIT) (K010328) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K010328 · Izon Business Products, Inc. · Chemistry device
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Apr 2001
Decision
66d
Days
Class 2
Risk

K010328 is an FDA 510(k) clearance for the MULTIPLE (IZON DNA BLOOD COLLECTION KIT). Classified as Blood/plasma Collection Device For Dna Testing (product code PJE), Class II - Special Controls.

Submitted by Izon Business Products, Inc. (West Nyack, US). The FDA issued a Cleared decision on April 9, 2001 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1675 - the FDA in vitro diagnostics and chemistry 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 Izon Business Products, Inc. devices

Submission Details

510(k) Number K010328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2001
Decision Date April 09, 2001
Days to Decision 66 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 88d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PJE Blood/plasma Collection Device For Dna Testing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1675
Definition A Blood Collection Device For Dna Testing Is An In Vitro Diagnostics Device Intended To Collect And Transport Blood Specimens To The Laboratory For Clinical Dna Testing.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.