Cleared Traditional

K983880 - TRANSFERRIN SPQ III ANTIBODY REAGENT SET

K983880 is the FDA 510(k) clearance for TRANSFERRIN SPQ III ANTIBODY REAGENT SET by DiaSorin, Inc.. It is a Class 2 Immunology device (product code DDG) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K983880 · DiaSorin, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
46d
Days
Class 2
Risk

K983880 is an FDA 510(k) clearance for the TRANSFERRIN SPQ III ANTIBODY REAGENT SET. Classified as Transferrin, Antigen, Antiserum, Control (product code DDG), Class II - Special Controls.

Submitted by DiaSorin, Inc. (Columbia, US). The FDA issued a Cleared decision on December 18, 1998 after a review of 46 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 DiaSorin, Inc. devices

Submission Details

510(k) Number K983880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1998
Decision Date December 18, 1998
Days to Decision 46 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
58d faster than avg
Panel avg: 104d · This submission: 46d
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 K983880.
K-ASSAY TRANSFERRIN
K993537 · Kamiya Biomedical Co. · Nov 1999
WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR
K993162 · Wako Chemicals USA, Inc. · Nov 1999
N LATEX STFR REAGENT
K991157 · Dade Behring, Inc. · Aug 1999
TRF
K983167 · Abbott Laboratories · Nov 1998
N ANTISERUM TO HUMAN TRANSFERRIN
K972840 · Behring Diagnostics, Inc. · Oct 1997
SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENT
K971958 · Beckman Instruments, Inc. · Aug 1997