Cleared Traditional

K082717 - AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5

K082717 is an FDA 510(k) clearance for AUDIT MICROCV TUMOR MARKERS LINEARITY SET, manufactured by Aalto Scientific, Ltd.. The device is a Class 1 Immunology device with product code JJY cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K082717 · Aalto Scientific, Ltd. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
43d
Days
Class 1
Risk

K082717 is an FDA 510(k) clearance for the AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5. 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 October 30, 2008 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1660 - the FDA immunology 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 - K082717

510(k) Number K082717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2008
Decision Date October 30, 2008
Days to Decision 43 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 105d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

JJY Device Classification - Class 1, General Controls

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 572
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