Cleared Traditional

K081478 - RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS

K081478 is an FDA 510(k) clearance for RNA MEDICAL GLUCOSE AND B-KETONE CALIBR..., 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 132-day FDA review.

K081478 · Bionostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
132d
Days
Class 1
Risk

K081478 is an FDA 510(k) clearance for the RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS. 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 October 6, 2008 after a review of 132 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 Bionostics, Inc. devices

FDA 510(k) Submission Details - K081478

510(k) Number K081478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2008
Decision Date October 06, 2008
Days to Decision 132 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
44d slower than avg
Panel avg: 88d · This submission: 132d
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 K081478.
ADVIA CENTAUR DHEAS MASTER CURVE MATERIALS
K091123 · Siemens Healthcare Diagnostics · Aug 2009
ELECSYS RUBELLA IGG CALCHECK
K090311 · Roche Diagnostics · May 2009
ELECSYS TOXO IGG CALCHECK
K083655 · Roche Diagnostics · Feb 2009
GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER, MODEL: MC002
K082395 · Bionostics, Inc. · Sep 2008
ELECSYS ANTI-TSHR CALCHECK
K080643 · Roche Diagnostics · Aug 2008
GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK
K081403 · Bionostics, Inc. · Jul 2008