Cleared Traditional

K914069 - REFLAB(TM) BRAND SYST PK LIQ REAGENT, APOLIPOP A-1 (FDA 510(k) Clearance)

Class I Immunology device.

K914069 · Medical Analysis Systems, Inc. · Immunology device
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Oct 1991
Decision
21d
Days
Class 1
Risk

K914069 is an FDA 510(k) clearance for the REFLAB(TM) BRAND SYST PK LIQ REAGENT, APOLIPOP A-1. 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 October 2, 1991 after a review of 21 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 Medical Analysis Systems, Inc. devices

Submission Details

510(k) Number K914069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1991
Decision Date October 02, 1991
Days to Decision 21 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 104d · This submission: 21d
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.