Cleared Traditional

K041870 - N APOLIPOPROTEIN STANDARD SERUM

K041870 is the FDA 510(k) clearance for N APOLIPOPROTEIN STANDARD SERUM by Dade Behring, Inc.. It is a Class 2 Chemistry device (product code JIX) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K041870 · Dade Behring, Inc. · Chemistry device
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Jul 2004
Decision
18d
Days
Class 2
Risk

K041870 is an FDA 510(k) clearance for the N APOLIPOPROTEIN STANDARD SERUM. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on July 27, 2004 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 K041870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2004
Decision Date July 27, 2004
Days to Decision 18 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
70d faster than avg
Panel avg: 88d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIX Calibrator, Multi-analyte Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JIX Calibrator, Multi-analyte Mixture

All 175
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K041870.
MULTI-LIPID CALIBRATOR
K042550 · Wako Chemicals USA, Inc. · Nov 2004
MICROALBUMIN MULTI-CALIBRATOR SET
K042243 · Diagnostic Chemicals , Ltd. · Oct 2004
HEMOSIL CALIBRATION PLASMA
K041905 · Instrumentation Laboratory CO · Sep 2004
CALIBRATOR FOR AUTOMATED SYSTEMS PROTEINS IN URINE/CSF
K040264 · Roche Diagnostics Corp. · Apr 2004
CALIBRATOR FOR AUTOMATED SYSTEMS PREALBUMIN-ASLO-CERULOPLASMIN (C.F.A.S. PAC)
K040245 · Roche Diagnostics Corp. · Mar 2004
DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIBRATOR
K032936 · Stanbio Laboratory · Mar 2004