Cleared Traditional

K112356 - GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE

K112356 is an FDA 510(k) clearance for GLUCOSE METER-CHECK CONTROL SOLUTION FO..., manufactured by Bionostics, Inc.. The device is a Class 1 Chemistry device with product code JJX cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K112356 · Bionostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
34d
Days
Class 1
Risk

K112356 is an FDA 510(k) clearance for the GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Bionostics, Inc. (Devens, US). The FDA issued a Cleared decision on September 19, 2011 after a review of 34 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 Bionostics, Inc. devices

FDA 510(k) Submission Details - K112356

510(k) Number K112356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2011
Decision Date September 19, 2011
Days to Decision 34 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
54d faster than avg
Panel avg: 88d · This submission: 34d
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 426
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K112356.
GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT
K112352 · Bionostics, Inc. · Dec 2011
ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS
K112603 · Beckman Coulter, Inc. · Nov 2011
CVM, UNCONJUGATED ESTRIOL (UE3) CALIBRATION VERIFICATION MATERIAL
K110061 · Siemens Healthcare Diagnostics · Sep 2011
ELECSYS MYOGLOBIN CALCHECK 5
K112113 · Roche Diagnostics · Sep 2011
IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS...
K111650 · Immunodiagnostic Systems , Ltd. · Sep 2011
ELECSYS N-MID OSTEOCALCIN CALCHECK 5
K112104 · Roche Diagnostics · Aug 2011