Cleared Traditional

K926272 - BECKMAN TRANSFERRIN KIT

K926272 is an FDA 510(k) clearance for BECKMAN TRANSFERRIN KIT, 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 293-day FDA review.

K926272 · Beckman Instruments, Inc. · Immunology device
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Oct 1993
Decision
293d
Days
Class 2
Risk

K926272 is an FDA 510(k) clearance for the BECKMAN TRANSFERRIN KIT. 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 October 7, 1993 after a review of 293 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 - K926272

510(k) Number K926272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1992
Decision Date October 07, 1993
Days to Decision 293 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
189d slower than avg
Panel avg: 104d · This submission: 293d
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 K926272.
IMMUNOCHEMISTRY SYS URINE TRANSFERRIN REAGENT
K963976 · Beckman Instruments, Inc. · Mar 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
IL TEST(TM) TRANSFERRIN (TRF)
K914993 · Instrumentation Laboratory CO · Jan 1992
TRANSFERRIN RID KIT
K914390 · The Binding Site, Ltd. · Dec 1991
RAICHEM(TM) SPIA(TM) TRANSFERRIN REAGENT
K900875 · Reagents Applications, Inc. · Mar 1990