Cleared Traditional

K073488 - DIAZYME APOLIPOPROTEIN B ASSAY

Also marketed or referenced as:
B CALIBRATOR, MODEL DZXXX

K073488 is an FDA 510(k) clearance for DIAZYME APOLIPOPROTEIN B ASSAY, manufactured by Diazyme Laboratories. The device is a Class 1 Chemistry device with product code MSJ cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K073488 · Diazyme Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
137d
Days
Class 1
Risk

K073488 is an FDA 510(k) clearance for the DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X. Classified as Apolipoproteins (product code MSJ), Class I - General Controls.

Submitted by Diazyme Laboratories (Poway, US). The FDA issued a Cleared decision on March 7, 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 Diazyme Laboratories devices

FDA 510(k) Submission Details - K073488

510(k) Number K073488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2007
Decision Date March 07, 2008
Days to Decision 137 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
49d slower than avg
Panel avg: 88d · This submission: 137d
Pathway characteristics
Predicate-based equivalence.

MSJ Device Classification - Class 1, General Controls

Product Code MSJ Apolipoproteins
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 - MSJ Apolipoproteins

All 32
Devices cleared under the same product code (MSJ) and FDA review panel - the closest regulatory comparables to K073488.
APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS
K061377 · Pointe Scientific, Inc., · Mar 2007
DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH
K063608 · Dade Behring, Inc. · Feb 2007
8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
K992662 · Bayer Corp. · Feb 2000
SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS
K970314 · Beckman Instruments, Inc. · Apr 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENT
K964010 · Beckman Instruments, Inc. · Feb 1997
NICHOLS APO B CHEMILUMINESCENCE ASSAY
K925702 · Nichols Institute Diagnostics · Dec 1992