Cleared Traditional

K884075 - IMMUNOCHEMICAL DETERMINATION OF TRANSFE...

K884075 is the FDA 510(k) clearance for IMMUNOCHEMICAL DETERMINATION OF TRANSFE... by Orion Diagnostica, Inc.. It is a Class 2 Immunology device (product code DDG) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K884075 · Orion Diagnostica, Inc. · Immunology device
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Oct 1988
Decision
22d
Days
Class 2
Risk

K884075 is an FDA 510(k) clearance for the IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN. Classified as Transferrin, Antigen, Antiserum, Control (product code DDG), Class II - Special Controls.

Submitted by Orion Diagnostica, Inc. (02101 Espoo, FI). The FDA issued a Cleared decision on October 19, 1988 after a review of 22 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 Orion Diagnostica, Inc. devices

Submission Details

510(k) Number K884075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1988
Decision Date October 19, 1988
Days to Decision 22 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 104d · This submission: 22d
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 39
Devices cleared under the same product code (DDG) and FDA review panel - the closest regulatory comparables to K884075.
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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
TINA-QUANT [A] TRANSFERRIN
K871896 · Boehringer Mannheim Corp. · Jun 1987