Cleared Traditional

K012431 - COMBITROL TS MULTI ANALYTE CONTROL

K012431 is the FDA 510(k) clearance for COMBITROL TS MULTI ANALYTE CONTROL by Bionostics, Inc.. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K012431 · Bionostics, Inc. · Chemistry device
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Aug 2001
Decision
28d
Days
Class 1
Risk

K012431 is an FDA 510(k) clearance for the COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL TS MULTI ANALYTE C.... Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Bionostics, Inc. (Acton, US). The FDA issued a Cleared decision on August 28, 2001 after a review of 28 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

Submission Details

510(k) Number K012431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2001
Decision Date August 28, 2001
Days to Decision 28 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
60d faster than avg
Panel avg: 88d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
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 - JJY Multi-analyte Controls, All Kinds (assayed)

All 320
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