Cleared Traditional

K914390 - TRANSFERRIN RID KIT

K914390 is the FDA 510(k) clearance for TRANSFERRIN RID KIT by The Binding Site, Ltd.. It is a Class 2 Immunology device (product code DDG) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K914390 · The Binding Site, Ltd. · Immunology device
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Dec 1991
Decision
69d
Days
Class 2
Risk

K914390 is an FDA 510(k) clearance for the TRANSFERRIN RID KIT. Classified as Transferrin, Antigen, Antiserum, Control (product code DDG), Class II - Special Controls.

Submitted by The Binding Site, Ltd. (Los Angeles, US). The FDA issued a Cleared decision on December 9, 1991 after a review of 69 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all The Binding Site, Ltd. devices

Submission Details

510(k) Number K914390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1991
Decision Date December 09, 1991
Days to Decision 69 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 104d · This submission: 69d
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 38
Devices cleared under the same product code (DDG) and FDA review panel - the closest regulatory comparables to K914390.
BOEHRINGER MANNHEIM TINA-QUANT TRANSFERRIN ASSAY
K933589 · Boehringer Mannheim Corp. · Nov 1993
BECKMAN TRANSFERRIN KIT
K926272 · Beckman Instruments, Inc. · Oct 1993
IL TEST(TM) TRANSFERRIN (TRF)
K914993 · Instrumentation Laboratory CO · Jan 1992
RAICHEM(TM) SPIA(TM) TRANSFERRIN REAGENT
K900875 · Reagents Applications, Inc. · Mar 1990
TRANSFERRIN
K873867 · Unipath , Ltd. · Oct 1987
QM300 TRANSFERRIN ANTIBODY PACK
K873789 · Kallestad Diag, A Div. of Erbamont, Inc. · Oct 1987