Cleared Traditional

K061377 - APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS

K061377 is an FDA 510(k) clearance for APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B ..., manufactured by Pointe Scientific, Inc.,. The device is a Class 1 Chemistry device with product code MSJ cleared through the Traditional 510(k) pathway after a 315-day FDA review.

K061377 · Pointe Scientific, Inc., · Chemistry device
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Mar 2007
Decision
315d
Days
Class 1
Risk

K061377 is an FDA 510(k) clearance for the APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS. Classified as Apolipoproteins (product code MSJ), Class I - General Controls.

Submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on March 28, 2007 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Pointe Scientific, Inc., devices

FDA 510(k) Submission Details - K061377

510(k) Number K061377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2006
Decision Date March 28, 2007
Days to Decision 315 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
227d slower than avg
Panel avg: 88d · This submission: 315d
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 36
Devices cleared under the same product code (MSJ) and FDA review panel - the closest regulatory comparables to K061377.
DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X
K073488 · Diazyme Laboratories · Mar 2008
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