Cleared Traditional

K890417 - SPQ(TM) ANTIBODY REAGENT SET II FOR C3

K890417 is an FDA 510(k) clearance for SPQ(TM) ANTIBODY REAGENT SET II FOR C3, manufactured by Atlantic Antibodies. The device is a Class 1 Immunology device with product code KTQ cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K890417 · Atlantic Antibodies · Immunology device
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Feb 1989
Decision
24d
Days
Class 1
Risk

K890417 is an FDA 510(k) clearance for the SPQ(TM) ANTIBODY REAGENT SET II FOR C3. Classified as Reagent, Complement (product code KTQ), Class I - General Controls.

Submitted by Atlantic Antibodies (Scarborough, US). The FDA issued a Cleared decision on February 17, 1989 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.4100 - 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 - K890417

510(k) Number K890417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1989
Decision Date February 17, 1989
Days to Decision 24 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
81d faster than avg
Panel avg: 105d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

KTQ Device Classification - Class 1, General Controls

Product Code KTQ Reagent, Complement
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.4100
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.