Cleared Traditional

K883349 - QLIA IMMUNOCHEMISTRY SYSTEM (FDA 510(k) Clearance)

Class I Immunology device.

K883349 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Immunology device
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Sep 1988
Decision
29d
Days
Class 1
Risk

K883349 is an FDA 510(k) clearance for the QLIA IMMUNOCHEMISTRY SYSTEM. Classified as Fluorometer (product code JZT), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on September 7, 1988 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.4520 - 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K883349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1988
Decision Date September 07, 1988
Days to Decision 29 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 104d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JZT Fluorometer
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.4520
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.