Cleared Traditional

K910552 - ROCHE REAGENT FOR APOLIPOPROTEIN B

K910552 is the FDA 510(k) clearance for ROCHE REAGENT FOR APOLIPOPROTEIN B by Roche Diagnostic Systems, Inc.. It is a Class 1 Immunology device (product code MSJ) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K910552 · Roche Diagnostic Systems, Inc. · Immunology device
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May 1991
Decision
89d
Days
Class 1
Risk

K910552 is an FDA 510(k) clearance for the ROCHE REAGENT FOR APOLIPOPROTEIN B. Classified as Apolipoproteins (product code MSJ), Class I - General Controls.

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on May 7, 1991 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1475 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K910552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1991
Decision Date May 07, 1991
Days to Decision 89 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 104d · This submission: 89d
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 25
Devices cleared under the same product code (MSJ) and FDA review panel - the closest regulatory comparables to K910552.
REFLAB(TM) BRAND SYST PK LIQ REAGENT, APOLIPOP A-1
K914069 · Medical Analysis Systems, Inc. · Oct 1991
REFLAB(TM) BR SYST PACK LIQ REAG, APOLIPOPROTEIN B
K912749 · Medical Analysis Systems, Inc. · Sep 1991
ROCHE REAGENT FOR APOLIPOPROTEIN A-1
K910551 · Roche Diagnostic Systems, Inc. · May 1991
QM300 APOLIPOPROTEIN A-I ANTIBODY PACK
K883713 · Kallestad Diag, A Div. of Erbamont, Inc. · Oct 1988
QM300 APOLIPOPROTEIN B ANTIBODY PACK
K883714 · Kallestad Diag, A Div. of Erbamont, Inc. · Oct 1988
TECHNICON DPA-1 APOLIPOPROTEIN B
K883491 · Technicon Instruments Corp. · Sep 1988