Cleared Traditional

K983340 - IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN ...

K983340 is the FDA 510(k) clearance for IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN ... by Beckman Coulter, Inc.. It is a Class 2 Immunology device (product code DBF) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K983340 · Beckman Coulter, Inc. · Immunology device
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Optimized for regulatory review, auditing and printing
Dec 1998
Decision
82d
Days
Class 2
Risk

K983340 is an FDA 510(k) clearance for the IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY S.... Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on December 14, 1998 after a review of 82 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 Beckman Coulter, Inc. devices

Submission Details

510(k) Number K983340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1998
Decision Date December 14, 1998
Days to Decision 82 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
22d faster than avg
Panel avg: 104d · This submission: 82d
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 62
Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K983340.
RANDOX FERRITIN
K000662 · Randox Laboratories, Ltd. · Apr 2000
N LATEX FERRITIN
K993273 · Dade Behring, Inc. · Nov 1999
NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY
K984186 · Nichols Institute Diagnostics · Feb 1999
ABBOTT ARCHITECT FERRITIN
K983759 · Abbott Laboratories · Dec 1998
BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY
K982714 · Bayer Corp. · Oct 1998
VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340)
K973331 · Ortho-Clinical Diagnostics, Inc. · Oct 1997