Cleared Traditional

K072523 - DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS

K072523 is an FDA 510(k) clearance for DIAZYME LDL-CHOLESTEROL REAGENT, manufactured by General Atomics. The device is a Class 1 Chemistry device with product code LBR cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K072523 · General Atomics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2008
Decision
137d
Days
Class 1
Risk

K072523 is an FDA 510(k) clearance for the DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS. Classified as Ldl & Vldl Precipitation, Hdl (product code LBR), Class I - General Controls.

Submitted by General Atomics (Poway, US). The FDA issued a Cleared decision on January 22, 2008 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1475 - 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 - K072523

510(k) Number K072523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2007
Decision Date January 22, 2008
Days to Decision 137 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
49d slower than avg
Panel avg: 88d · This submission: 137d
Pathway characteristics
Predicate-based equivalence.

LBR Device Classification - Class 1, General Controls

Product Code LBR Ldl & Vldl Precipitation, Hdl
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1475
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 - LBR Ldl & Vldl Precipitation, Hdl

All 51
Devices cleared under the same product code (LBR) and FDA review panel - the closest regulatory comparables to K072523.
DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR
K050823 · Teco Diagnostics · Jul 2005
RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER
K023784 · Hemagen Diagnostics, Inc. · Dec 2002
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
K012593 · Ortho-Clinical Diagnostics, Inc. · Aug 2001
AUTOHDL CHOLESTEROL REAGENT SET
K992002 · Pointe Scientific, Inc., · Aug 1999
MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470
K990247 · Polymer Technology Systems, Inc. · May 1999
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT
K984303 · Ortho-Clinical Diagnostics, Inc. · Jan 1999