Cleared Traditional

AB-TROL AND PRIVATE LABEL GLUCOSE CONTROL SOLUTION (K080273) - FDA 510(k) Clearance

Class I Chemistry device.

K080273 · Fujirebio Diagnostics Texas, Inc. · Chemistry device
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Aug 2008
Decision
189d
Days
Class 1
Risk

K080273 is an FDA 510(k) clearance for the AB-TROL AND PRIVATE LABEL GLUCOSE CONTROL SOLUTION. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Fujirebio Diagnostics Texas, Inc. (Seguin, US). The FDA issued a Cleared decision on August 8, 2008 after a review of 189 days - an extended review 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: 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 Texas, Inc. devices

Submission Details

510(k) Number K080273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2008
Decision Date August 08, 2008
Days to Decision 189 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 88d · This submission: 189d
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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