Cleared Traditional

K042318 - AUDIT MICROCV GENERAL CHEMISTRY LINEARI...

K042318 is the FDA 510(k) clearance for AUDIT MICROCV GENERAL CHEMISTRY LINEARI... by Aalto Scientific, Ltd.. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K042318 · Aalto Scientific, Ltd. · Chemistry device
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Dec 2004
Decision
105d
Days
Class 1
Risk

K042318 is an FDA 510(k) clearance for the AUDIT MICROCV GENERAL CHEMISTRY LINEARITY SET. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Aalto Scientific, Ltd. (Carlsbad, US). The FDA issued a Cleared decision on December 9, 2004 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Aalto Scientific, Ltd. devices

Submission Details

510(k) Number K042318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2004
Decision Date December 09, 2004
Days to Decision 105 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 88d · This submission: 105d
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 320
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