Cleared Traditional

K101434 - AUDIT MICROCV PROCALCITONIN LINEARITY

K101434 is an FDA 510(k) clearance for AUDIT MICROCV PROCALCITONIN LINEARITY, manufactured by Aalto Scientific, Ltd.. The device is a Class 1 Microbiology device with product code MJX cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K101434 · Aalto Scientific, Ltd. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
62d
Days
Class 1
Risk

K101434 is an FDA 510(k) clearance for the AUDIT MICROCV PROCALCITONIN LINEARITY. Classified as Kit, Serological, Positive Control (product code MJX), Class I - General Controls.

Submitted by Aalto Scientific, Ltd. (Carlsbad, US). The FDA issued a Cleared decision on July 22, 2010 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.1660 - the FDA microbiology 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 Aalto Scientific, Ltd. devices

FDA 510(k) Submission Details - K101434

510(k) Number K101434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2010
Decision Date July 22, 2010
Days to Decision 62 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 102d · This submission: 62d
Pathway characteristics
Predicate-based equivalence.

MJX Device Classification - Class 1, General Controls

Product Code MJX Kit, Serological, Positive Control
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 - MJX Kit, Serological, Positive Control

Devices cleared under the same product code (MJX) and FDA review panel - the closest regulatory comparables to K101434.
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OPUS(R) SEROLOGY CONTROLS, MODIFICATION
K934137 · Pb Diagnostic Systems, Inc. · Mar 1994