Cleared Traditional

K890561 - SPQ(TM) ANTIBODY REAGENT SET II FOR IGM

K890561 is the FDA 510(k) clearance for SPQ(TM) ANTIBODY REAGENT SET II FOR IGM by Atlantic Antibodies. It is a Class 2 Immunology device (product code CFQ) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K890561 · Atlantic Antibodies · Immunology device
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Feb 1989
Decision
30d
Days
Class 2
Risk

K890561 is an FDA 510(k) clearance for the SPQ(TM) ANTIBODY REAGENT SET II FOR IGM. Classified as Radioimmunoassay, Immunoglobulins (g, A, M) (product code CFQ), Class II - Special Controls.

Submitted by Atlantic Antibodies (Scarborough, US). The FDA issued a Cleared decision on February 23, 1989 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - 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

Submission Details

510(k) Number K890561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1989
Decision Date February 23, 1989
Days to Decision 30 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 104d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CFQ Radioimmunoassay, Immunoglobulins (g, A, M)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 - CFQ Radioimmunoassay, Immunoglobulins (g, A, M)

All 11
Devices cleared under the same product code (CFQ) and FDA review panel - the closest regulatory comparables to K890561.
OLYMPUS IGA IMMUNOTURBIDIMETRIC REAGENT
K951055 · Olympus America, Inc. · Apr 1995
OLYMPUS IGM IMMUNOTURBIDIMETRIC REAGENT
K950900 · Olympus America, Inc. · Mar 1995
TITAN GEL IFE TRIVALENT ANTISERUM
K891188 · Helena Laboratories · Mar 1989
MONOCLONAL RADIAL IMMUNODIFFUSION KIT
K881928 · The Binding Site, Ltd. · Jul 1988
IMMUNOGLOBULIN A TEST SYSTEM
K881827 · The Binding Site, Ltd. · Jun 1988
IMMUNOGLOBULIN M TEST SYSTEM
K881828 · The Binding Site, Ltd. · Jun 1988