Cleared Traditional

NOVA-ONE LIPID CONTROL (SPECIAL LOW INTERFERENCE LIQUID LIPID CONTROL) (K040352) - FDA 510(k) Clearance

Class I Toxicology device.

K040352 · Bioresource Technology, Inc. · Toxicology device
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Apr 2004
Decision
50d
Days
Class 1
Risk

K040352 is an FDA 510(k) clearance for the NOVA-ONE LIPID CONTROL (SPECIAL LOW INTERFERENCE LIQUID LIPID CONTROL). Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Bioresource Technology, Inc. (Fort Lauderdale, US). The FDA issued a Cleared decision on April 2, 2004 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1660 - the FDA toxicology 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: 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 Bioresource Technology, Inc. devices

Submission Details

510(k) Number K040352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2004
Decision Date April 02, 2004
Days to Decision 50 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 87d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJY Multi-analyte Controls, All Kinds (assayed)

All 672
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