Cleared Traditional

K890416 - SPQ(TM) ANTIBODY REAGENT SET II FOR IGG

K890416 is the FDA 510(k) clearance for SPQ(TM) ANTIBODY REAGENT SET II FOR IGG by Atlantic Antibodies. It is a Class 2 Immunology device (product code DEW) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K890416 · Atlantic Antibodies · Immunology device
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Feb 1989
Decision
29d
Days
Class 2
Risk

K890416 is an FDA 510(k) clearance for the SPQ(TM) ANTIBODY REAGENT SET II FOR IGG. Classified as Igg, Antigen, Antiserum, Control (product code DEW), Class II - Special Controls.

Submitted by Atlantic Antibodies (Scarborough, US). The FDA issued a Cleared decision on February 22, 1989 after a review of 29 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 K890416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1989
Decision Date February 22, 1989
Days to Decision 29 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 104d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DEW Igg, Antigen, Antiserum, Control
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 - DEW Igg, Antigen, Antiserum, Control

All 55
Devices cleared under the same product code (DEW) and FDA review panel - the closest regulatory comparables to K890416.
ZORBA(TM) IGG REMOVAL REAGENT
K924197 · Zeus Scientific, Inc. · Dec 1992
MODIFIED TECHNICON DPA-1(TM) SYSTEM
K900943 · Technicon Instruments Corp. · Apr 1990
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS)
K891385 · Vitek Systems, Inc. · Apr 1989
QM300 IGG ANTIBODY PACK
K882083 · Kallestad Diag, A Div. of Erbamont, Inc. · Jul 1988
WAKO(TM) IGG-HA DIRECT
K880784 · Wako Chemicals USA, Inc. · Jun 1988
GULLSORB IGG INACTIVATION REAGENT
K875254 · Gull Laboratories, Inc. · Feb 1988