Cleared Traditional

APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS (K061377) - FDA 510(k) Clearance

Class I Chemistry device.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
227d slower than avg
Panel avg: 88d · This submission: 315d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 49
Devices cleared under the same product code (MSJ) and FDA review panel - the closest regulatory comparables to K061377.
DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH
K063608 · Dade Behring, Inc. · Feb 2007
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
IL TEST APOLIPOROTEIN B (APO B)
K923080 · Instrumentation Laboratory CO · Oct 1992
IL TEST APOLIPOPROTEIN A1
K923087 · Instrumentation Laboratory CO · Oct 1992
ROCHE REAGENT FOR APOLIPOPROTEIN A-1
K910551 · Roche Diagnostic Systems, Inc. · May 1991