Cleared Traditional

K963976 - IMMUNOCHEMISTRY SYS URINE TRANSFERRIN REAGENT (FDA 510(k) Clearance)

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K963976 · Beckman Instruments, Inc. · Immunology device
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Mar 1997
Decision
166d
Days
Class 2
Risk

K963976 is an FDA 510(k) clearance for the IMMUNOCHEMISTRY SYS URINE TRANSFERRIN REAGENT. Classified as Transferrin, Antigen, Antiserum, Control (product code DDG), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on March 19, 1997 after a review of 166 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5880 - 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 K963976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1996
Decision Date March 19, 1997
Days to Decision 166 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
62d slower than avg
Panel avg: 104d · This submission: 166d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DDG Transferrin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5880
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.