Cleared Traditional

K964781 - IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT (FDA 510(k) Clearance)

Class I Immunology device.

K964781 · Beckman Instruments, Inc. · Immunology device
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May 1997
Decision
163d
Days
Class 1
Risk

K964781 is an FDA 510(k) clearance for the IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT. Classified as Prealbumin, Fitc, Antigen, Antiserum, Control (product code DDS), Class I - General Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on May 9, 1997 after a review of 163 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5060 - 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 Beckman Instruments, Inc. devices

Submission Details

510(k) Number K964781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1996
Decision Date May 09, 1997
Days to Decision 163 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 104d · This submission: 163d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DDS Prealbumin, Fitc, Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5060
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.