Cleared Traditional

K883492 - TECHNICON DPA-1 IMMUNOGLOBULIN A

K883492 is an FDA 510(k) clearance for TECHNICON DPA-1 IMMUNOGLOBULIN A, manufactured by Technicon Instruments Corp.. The device is a Class 2 Immunology device with product code CZP cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K883492 · Technicon Instruments Corp. · Immunology device
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Sep 1988
Decision
37d
Days
Class 2
Risk

K883492 is an FDA 510(k) clearance for the TECHNICON DPA-1 IMMUNOGLOBULIN A. Classified as Iga, Antigen, Antiserum, Control (product code CZP), Class II - Special Controls.

Submitted by Technicon Instruments Corp. (Tarrytown, US). The FDA issued a Cleared decision on September 22, 1988 after a review of 37 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 Technicon Instruments Corp. devices

FDA 510(k) Submission Details - K883492

510(k) Number K883492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1988
Decision Date September 22, 1988
Days to Decision 37 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
68d faster than avg
Panel avg: 105d · This submission: 37d
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 K883492.
RAICHEM(TM) SPIA(TM) IGA REAGENTS
K894418 · Reagents Applications, Inc. · Aug 1989
SPQ(TM) ANTIBODY REAGENT SET II FOR IGA
K890560 · Atlantic Antibodies · Feb 1989
IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A
K884040 · Orion Diagnostica, Inc. · Oct 1988
WAKO(TM) IGA-HA DIRECT
K880803 · Wako Chemicals USA, Inc. · Mar 1988
IMMUNOGLOBULINS A
K873869 · Unipath , Ltd. · Oct 1987
QM300 IGA, ANTIGEN, ANTISERUM, CONTROL
K871940 · Kallestad Diag, A Div. of Erbamont, Inc. · Jun 1987