Cleared Traditional

K110436 - FDI GLUCOSE CONTROL SOLUTION FOR AVIVA

K110436 is an FDA 510(k) clearance for FDI GLUCOSE CONTROL SOLUTION FOR AVIVA, manufactured by Fujirebio Diagnostics,Inc.. The device is a Class 1 Chemistry device with product code JJX cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K110436 · Fujirebio Diagnostics,Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
64d
Days
Class 1
Risk

K110436 is an FDA 510(k) clearance for the FDI GLUCOSE CONTROL SOLUTION FOR AVIVA. 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 April 20, 2011 after a review of 64 days - a notably fast clearance 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: 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 Fujirebio Diagnostics,Inc. devices

FDA 510(k) Submission Details - K110436

510(k) Number K110436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2011
Decision Date April 20, 2011
Days to Decision 64 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
24d faster than avg
Panel avg: 88d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

JJX Device Classification - Class 1, General Controls

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)

All 434
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K110436.
DROPPER A1C DIABETES CONTROL
K103744 · Quantimetrix Corp. · May 2011
ELECSYS PROLACTIN II CALCHECK 5
K110613 · Roche Diagnostics · May 2011
IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM)
K103683 · Siemens Healthcare Diagnostics · Apr 2011
IDS-ISYS IFG-I CONTROL SET
K110412 · Immunodiagnostic Systems , Ltd. · Mar 2011
LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION
K103553 · Bionostics, Inc. · Feb 2011
FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE
K103450 · Fujirebio Diagnostics,Inc. · Jan 2011