Cleared Traditional

BECKMAN TRANSFERRIN KIT (K926272) - FDA 510(k) Clearance

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

K926272 · Beckman Instruments, Inc. · Immunology device
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Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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.

Regulatory Peers - DDG Transferrin, Antigen, Antiserum, Control

All 23
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
TINA-QUANT [A] TRANSFERRIN
K871896 · Boehringer Mannheim Corp. · Jun 1987
PRECIMAT(R) TRANSFERRIN
K871022 · Boehringer Mannheim Corp. · May 1987