Cleared Traditional

ABBOTT ARCHITECT FERRITIN (K983759) - FDA 510(k) Clearance

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

K983759 · Abbott Laboratories · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
42d
Days
Class 2
Risk

K983759 is an FDA 510(k) clearance for the ABBOTT ARCHITECT FERRITIN. Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on December 7, 1998 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5340 - 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 Abbott Laboratories devices

Submission Details

510(k) Number K983759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1998
Decision Date December 07, 1998
Days to Decision 42 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 faster than avg
Panel avg: 104d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DBF Ferritin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5340
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 - DBF Ferritin, Antigen, Antiserum, Control

All 30
Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K983759.
RANDOX FERRITIN
K000662 · Randox Laboratories, Ltd. · Apr 2000
N LATEX FERRITIN
K993273 · Dade Behring, Inc. · Nov 1999
IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN CALIBRATOR
K983340 · Beckman Coulter, Inc. · Dec 1998
MODIFICATION OF OPUS FERRITIN TEST SYSTEM
K973202 · Behring Diagnostics, Inc. · Sep 1997
OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT
K963170 · Olympus America, Inc. · Dec 1996
N LATEX FERRITIN
K950707 · Behring Diagnostics, Inc. · Mar 1995