Cleared Traditional

K133197 - FDI LEVEL I AND LEVEL II GLUCOSE CONTRO...

K133197 is the FDA 510(k) clearance for FDI LEVEL I AND LEVEL II GLUCOSE CONTRO... by Fujirebio Diagnostics,Inc.. It is a Class 1 Chemistry device (product code JJX) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K133197 · Fujirebio Diagnostics,Inc. · Chemistry device
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Jan 2014
Decision
92d
Days
Class 1
Risk

K133197 is an FDA 510(k) clearance for the FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Fujirebio Diagnostics,Inc. (Seguin, US). The FDA issued a Cleared decision on January 17, 2014 after a review of 92 days - within the typical 510(k) review window.

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 Fujirebio Diagnostics,Inc. devices

Submission Details

510(k) Number K133197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2013
Decision Date January 17, 2014
Days to Decision 92 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
4d slower than avg
Panel avg: 88d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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)

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