Cleared Traditional

K890563 - SPQ(TM) ANTIBODY REAGENT SET II FOR TRF

K890563 is an FDA 510(k) clearance for SPQ(TM) ANTIBODY REAGENT SET II FOR TRF, manufactured by Atlantic Antibodies. The device is a Class 2 Immunology device with product code DDG cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K890563 · Atlantic Antibodies · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1989
Decision
38d
Days
Class 2
Risk

K890563 is an FDA 510(k) clearance for the SPQ(TM) ANTIBODY REAGENT SET II FOR TRF. Classified as Transferrin, Antigen, Antiserum, Control (product code DDG), Class II - Special Controls.

Submitted by Atlantic Antibodies (Scarborough, US). The FDA issued a Cleared decision on March 3, 1989 after a review of 38 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 Atlantic Antibodies devices

FDA 510(k) Submission Details - K890563

510(k) Number K890563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1989
Decision Date March 03, 1989
Days to Decision 38 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 105d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DDG Device Classification - Class 2, Special Controls

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 44
Devices cleared under the same product code (DDG) and FDA review panel - the closest regulatory comparables to K890563.
IL TEST(TM) TRANSFERRIN (TRF)
K914993 · Instrumentation Laboratory CO · Jan 1992
TRANSFERRIN RID KIT
K914390 · The Binding Site, Ltd. · Dec 1991
RAICHEM(TM) SPIA(TM) TRANSFERRIN REAGENT
K900875 · Reagents Applications, Inc. · Mar 1990
IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN
K884075 · Orion Diagnostica, Inc. · Oct 1988
TRANSFERRIN
K873867 · Unipath , Ltd. · Oct 1987
QM300 TRANSFERRIN ANTIBODY PACK
K873789 · Kallestad Diag, A Div. of Erbamont, Inc. · Oct 1987