Cleared Traditional

K912749 - REFLAB(TM) BR SYST PACK LIQ REAG

K912749 is the FDA 510(k) clearance for REFLAB(TM) BR SYST PACK LIQ REAG by Medical Analysis Systems, Inc.. It is a Class 1 Immunology device (product code MSJ) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K912749 · Medical Analysis Systems, Inc. · Immunology device
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Sep 1991
Decision
94d
Days
Class 1
Risk

K912749 is an FDA 510(k) clearance for the REFLAB(TM) BR SYST PACK LIQ REAG, APOLIPOPROTEIN B. Classified as Apolipoproteins (product code MSJ), Class I - General Controls.

Submitted by Medical Analysis Systems, Inc. (Camarillo, US). The FDA issued a Cleared decision on September 23, 1991 after a review of 94 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medical Analysis Systems, Inc. devices

Submission Details

510(k) Number K912749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1991
Decision Date September 23, 1991
Days to Decision 94 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 104d · This submission: 94d
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 30
Devices cleared under the same product code (MSJ) and FDA review panel - the closest regulatory comparables to K912749.
IL TEST APOLIPOPROTEIN A1
K923087 · Instrumentation Laboratory CO · Oct 1992
APOLIPOPROTEIN TEST SYSTEM
K921037 · Baxter Diagnostics, Inc. · May 1992
REFLAB(TM) BRAND SYST PK LIQ REAGENT, APOLIPOP A-1
K914069 · Medical Analysis Systems, Inc. · Oct 1991
ROCHE REAGENT FOR APOLIPOPROTEIN A-1
K910551 · Roche Diagnostic Systems, Inc. · May 1991
ROCHE REAGENT FOR APOLIPOPROTEIN B
K910552 · Roche Diagnostic Systems, Inc. · May 1991
BACTON TM, BASIC TM, APO B REAGENT
K893884 · Catachem, Inc. · Jun 1989