Cleared Traditional

K091914 - OMNIS HEALTH EMBRACE GLUCOSE CONTROL SO...

K091914 is the FDA 510(k) clearance for OMNIS HEALTH EMBRACE GLUCOSE CONTROL SO... by Bionostics, Inc.. It is a Class 1 Chemistry device (product code JJX) cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K091914 · Bionostics, Inc. · Chemistry device
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Nov 2009
Decision
129d
Days
Class 1
Risk

K091914 is an FDA 510(k) clearance for the OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION. 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 November 6, 2009 after a review of 129 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

Submission Details

510(k) Number K091914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2009
Decision Date November 06, 2009
Days to Decision 129 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
41d slower than avg
Panel avg: 88d · This submission: 129d
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)

All 274
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