Cleared Traditional

K012468 - MODIFICATION TO N/T PROTEIN CONTROL SL

K012468 is the FDA 510(k) clearance for MODIFICATION TO N/T PROTEIN CONTROL SL by Dade Behring, Inc.. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K012468 · Dade Behring, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
33d
Days
Class 1
Risk

K012468 is an FDA 510(k) clearance for the MODIFICATION TO N/T PROTEIN CONTROL SL. 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 4, 2001 after a review of 33 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 Dade Behring, Inc. devices

Submission Details

510(k) Number K012468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2001
Decision Date September 04, 2001
Days to Decision 33 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
55d faster than avg
Panel avg: 88d · This submission: 33d
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 K012468.
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K012431 · Bionostics, Inc. · Aug 2001
ABBOTT TUMORMARKER-MCC (LYOPHILIZED), LEVELS 1 AND 2, 2ML NO. 6E21-10
K011853 · Bio-Rad · Jul 2001