Cleared Traditional

K823567 - IMMUNOGLOBULIN ASSAYS-IGG, IGA, IGM

K823567 is an FDA 510(k) clearance for IMMUNOGLOBULIN ASSAYS-IGG, manufactured by Syva Co.. The device is a Class 2 Immunology device with product code CZP cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K823567 · Syva Co. · Immunology device
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Dec 1982
Decision
27d
Days
Class 2
Risk

K823567 is an FDA 510(k) clearance for the IMMUNOGLOBULIN ASSAYS-IGG, IGA, IGM. Classified as Iga, Antigen, Antiserum, Control (product code CZP), Class II - Special Controls.

Submitted by Syva Co. (Walker, US). The FDA issued a Cleared decision on December 30, 1982 after a review of 27 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 Syva Co. devices

FDA 510(k) Submission Details - K823567

510(k) Number K823567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1982
Decision Date December 30, 1982
Days to Decision 27 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
78d faster than avg
Panel avg: 105d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CZP Device Classification - Class 2, Special Controls

Product Code CZP Iga, 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 - CZP Iga, Antigen, Antiserum, Control

All 48
Devices cleared under the same product code (CZP) and FDA review panel - the closest regulatory comparables to K823567.
AMER. HISTO-ID SYS PRIMARY IGA 2720-21
K842330 · Bartels Immunodiagnostic Supplies, Inc. · Aug 1984
TIA-IGA REAGENT & CALIBRATOR SETS
K831102 · Worthington Diagnostic Systems · Apr 1983
IMMUNOGLOBULIN CONTROL
K823566 · Syva Co. · Dec 1982
IMMUNO DIAGNOSTICS ASSAY
K822026 · Helena Laboratories · Aug 1982
ACA IMMUNOGLOBIN A TEST PACK
K812631 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1981
ACA IMMUNOGLOBULIN A/M CALIBRATORS
K812633 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1981