Cleared Traditional

K963976 - IMMUNOCHEMISTRY SYS URINE TRANSFERRIN R...

K963976 is an FDA 510(k) clearance for IMMUNOCHEMISTRY SYS URINE TRANSFERRIN R..., manufactured by Beckman Instruments, Inc.. The device is a Class 2 Immunology device with product code DDG cleared through the Traditional 510(k) pathway after a 166-day FDA review.

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

FDA 510(k) Submission Details - K963976

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
Combination Product No
PCCP Authorized No
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.

DDG Device Classification - Class 2, Special Controls

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.

Regulatory Peers - DDG Transferrin, Antigen, Antiserum, Control

All 40
Devices cleared under the same product code (DDG) and FDA review panel - the closest regulatory comparables to K963976.
N ANTISERUM TO HUMAN TRANSFERRIN
K972840 · Behring Diagnostics, Inc. · Oct 1997
SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENT
K971958 · Beckman Instruments, Inc. · Aug 1997
N-ASSAY TIA TRANSFERRIN TEST KIT
K964295 · Crestat Diagnostics, Inc. · Jun 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM TRANSFERRIN (TRF) REAGENT
K963427 · Beckman Instruments, Inc. · Oct 1996
BOEHRINGER MANNHEIM TINA-QUANT TRANSFERRIN ASSAY
K933589 · Boehringer Mannheim Corp. · Nov 1993
BECKMAN TRANSFERRIN KIT
K926272 · Beckman Instruments, Inc. · Oct 1993