Cleared Traditional

K880784 - WAKO(TM) IGG-HA DIRECT

K880784 is an FDA 510(k) clearance for WAKO(TM) IGG-HA DIRECT, manufactured by Wako Chemicals USA, Inc.. The device is a Class 2 Immunology device with product code DEW cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K880784 · Wako Chemicals USA, Inc. · Immunology device
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Jun 1988
Decision
101d
Days
Class 2
Risk

K880784 is an FDA 510(k) clearance for the WAKO(TM) IGG-HA DIRECT. Classified as Igg, Antigen, Antiserum, Control (product code DEW), Class II - Special Controls.

Submitted by Wako Chemicals USA, Inc. (Dallas, US). The FDA issued a Cleared decision on June 6, 1988 after a review of 101 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Wako Chemicals USA, Inc. devices

FDA 510(k) Submission Details - K880784

510(k) Number K880784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1988
Decision Date June 06, 1988
Days to Decision 101 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
4d faster than avg
Panel avg: 105d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DEW Device Classification - Class 2, Special Controls

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 57
Devices cleared under the same product code (DEW) and FDA review panel - the closest regulatory comparables to K880784.
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS)
K891385 · Vitek Systems, Inc. · Apr 1989
SPQ(TM) ANTIBODY REAGENT SET II FOR IGG
K890416 · Atlantic Antibodies · Feb 1989
QM300 IGG ANTIBODY PACK
K882083 · Kallestad Diag, A Div. of Erbamont, Inc. · Jul 1988
GULLSORB IGG INACTIVATION REAGENT
K875254 · Gull Laboratories, Inc. · Feb 1988
IMMUNOGLOBULINS G
K873870 · Unipath , Ltd. · Oct 1987
TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT
K872800 · Abbott Laboratories · Aug 1987