Cleared Traditional

K063838 - LIPOPROTEIN(A)

K063838 is the FDA 510(k) clearance for LIPOPROTEIN(A) by Thermo Electron OY. It is a Class 2 Chemistry device (product code DFC) cleared through the Traditional 510(k) pathway after a 275-day FDA review.

K063838 · Thermo Electron OY · Chemistry device
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Sep 2007
Decision
275d
Days
Class 2
Risk

K063838 is an FDA 510(k) clearance for the LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH. Classified as Lipoprotein, Low-density, Antigen, Antiserum, Control (product code DFC), Class II - Special Controls.

Submitted by Thermo Electron OY (Vantaa, FI). The FDA issued a Cleared decision on September 27, 2007 after a review of 275 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5600 - 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.

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Submission Details

510(k) Number K063838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2006
Decision Date September 27, 2007
Days to Decision 275 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
187d slower than avg
Panel avg: 88d · This submission: 275d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DFC Lipoprotein, Low-density, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5600
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 - DFC Lipoprotein, Low-density, Antigen, Antiserum, Control

All 31
Devices cleared under the same product code (DFC) and FDA review panel - the closest regulatory comparables to K063838.
Diazyme Lipoprotein (a) Assay
K180074 · Diazyme Laboratories, Inc. · Mar 2018
ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR
K123046 · Siemens Healthcare Diagnostics, Inc. · Dec 2012
COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190
K122722 · Roche Diagnostics · Nov 2012
K-ASSAY LP(A) CONTROLS
K023853 · Kamiya Biomedical Co. · Dec 2002
K-ASSAY LP(A) ASSAY
K021660 · Kamiya Biomedical Co. · Jul 2002
N LATEX LP(A)
K013128 · Dade Behring, Inc. · Jan 2002