Cleared Traditional

K082488 - DIAZYME LP(A) ASSAY

K082488 is an FDA 510(k) clearance for DIAZYME LP(A) ASSAY, manufactured by General Atomics. The device is a Class 2 Chemistry device with product code DFC cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K082488 · General Atomics · Chemistry device
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Jan 2009
Decision
138d
Days
Class 2
Risk

K082488 is an FDA 510(k) clearance for the DIAZYME LP(A) ASSAY. Classified as Lipoprotein, Low-density, Antigen, Antiserum, Control (product code DFC), Class II - Special Controls.

Submitted by General Atomics (Poway, US). The FDA issued a Cleared decision on January 13, 2009 after a review of 138 days - within the typical 510(k) review window.

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.

View all General Atomics devices

FDA 510(k) Submission Details - K082488

510(k) Number K082488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2008
Decision Date January 13, 2009
Days to Decision 138 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
50d slower than avg
Panel avg: 88d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DFC Device Classification - Class 2, Special Controls

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 36
Devices cleared under the same product code (DFC) and FDA review panel - the closest regulatory comparables to K082488.
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
QUANTIA LA(A)
K050487 · Biokit, S.A. · Apr 2005
K-ASSAY LP(A) CONTROLS
K023853 · Kamiya Biomedical Co. · Dec 2002
K-ASSAY LP(A) ASSAY
K021660 · Kamiya Biomedical Co. · Jul 2002