Cleared Traditional

K101809 - FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20

K101809 is an FDA 510(k) clearance for FUJIREBIO DIAGNOSTICS TUMOR MARKER CONT..., manufactured by Fujirebio Diagnostics,Inc.. The device is a Class 1 Immunology device with product code JJY cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K101809 · Fujirebio Diagnostics,Inc. · Immunology device
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Oct 2010
Decision
98d
Days
Class 1
Risk

K101809 is an FDA 510(k) clearance for the FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on October 5, 2010 after a review of 98 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fujirebio Diagnostics,Inc. devices

FDA 510(k) Submission Details - K101809

510(k) Number K101809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2010
Decision Date October 05, 2010
Days to Decision 98 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
7d faster than avg
Panel avg: 105d · This submission: 98d
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)

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