Cleared Traditional

K101427 - AUDIT MICROCV HS-CRP LINEARITY SET

K101427 is an FDA 510(k) clearance for AUDIT MICROCV HS-CRP LINEARITY SET, manufactured by Aalto Scientific, Ltd.. The device is a Class 1 Chemistry device with product code JJX cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K101427 · Aalto Scientific, Ltd. · Chemistry device
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Dec 2010
Decision
216d
Days
Class 1
Risk

K101427 is an FDA 510(k) clearance for the AUDIT MICROCV HS-CRP LINEARITY SET. 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 216 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

FDA 510(k) Submission Details - K101427

510(k) Number K101427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2010
Decision Date December 23, 2010
Days to Decision 216 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
128d slower than avg
Panel avg: 88d · This submission: 216d
Pathway characteristics
Predicate-based equivalence.

JJX Device Classification - Class 1, General Controls

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.

Regulatory Peers - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 426
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