Cleared Traditional

K100715 - AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5 (FDA 510(k) Clearance)

Class I Chemistry device.

K100715 · Aalto Scientific, Ltd. · Chemistry device
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Dec 2010
Decision
286d
Days
Class 1
Risk

K100715 is an FDA 510(k) clearance for the AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Aalto Scientific, Ltd. (Carlsbad, US). The FDA issued a Cleared decision on December 23, 2010 after a review of 286 days - an extended review cycle.

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 K100715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2010
Decision Date December 23, 2010
Days to Decision 286 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
198d slower than avg
Panel avg: 88d · This submission: 286d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
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.