Cleared Traditional

K032237 - N/T PROTEIN CONTROL

K032237 is the FDA 510(k) clearance for N/T PROTEIN CONTROL by Dade Behring, Inc.. It is a Class 1 Immunology device (product code JJY) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K032237 · Dade Behring, Inc. · Immunology device
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Sep 2003
Decision
46d
Days
Class 1
Risk

K032237 is an FDA 510(k) clearance for the N/T PROTEIN CONTROL. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on September 5, 2003 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1660 - the FDA immunology device 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 Dade Behring, Inc. devices

Submission Details

510(k) Number K032237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2003
Decision Date September 05, 2003
Days to Decision 46 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 104d · This submission: 46d
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 373
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K032237.
LYPHOCHEK ASSAYED CHEMISTRY CONTROL
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K033937 · Roche Diagnostics Corp. · Jan 2004
QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945
K033387 · Bio-Rad · Dec 2003
ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL
K032453 · Bionostics, Inc. · Aug 2003
MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL
K032335 · Medical Analysis Systems, Inc. · Aug 2003
ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC
K032089 · Roche Diagnostics Corp. · Jul 2003