Cleared Traditional

K130157 - AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET

K130157 is an FDA 510(k) clearance for AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID ..., 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 55-day FDA review.

K130157 · Aalto Scientific, Ltd. · Chemistry device
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Mar 2013
Decision
55d
Days
Class 1
Risk

K130157 is an FDA 510(k) clearance for the AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID 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 March 19, 2013 after a review of 55 days - a notably fast clearance 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: 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 Aalto Scientific, Ltd. devices

FDA 510(k) Submission Details - K130157

510(k) Number K130157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2013
Decision Date March 19, 2013
Days to Decision 55 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
33d faster than avg
Panel avg: 88d · This submission: 55d
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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