Cleared Special

K040435 - ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2

K040435 is an FDA 510(k) clearance for ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2, manufactured by Roche Diagnostics Corp.. The device is a Class 2 Immunology device with product code CZP cleared through the Special 510(k) pathway after a 20-day FDA review.

K040435 · Roche Diagnostics Corp. · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
20d
Days
Class 2
Risk

K040435 is an FDA 510(k) clearance for the ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2. Classified as Iga, Antigen, Antiserum, Control (product code CZP), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on March 10, 2004 after a review of 20 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K040435

510(k) Number K040435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2004
Decision Date March 10, 2004
Days to Decision 20 days
Submission Type Special
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 105d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

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 K040435.
Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M
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K024038 · Dade Behring, Inc. · Feb 2003
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K993927 · Wako Chemicals USA, Inc. · Jan 2000
IGA
K983359 · Abbott Laboratories · Nov 1998
QUANTEX IGA
K962200 · Instrumentation Laboratory CO · Sep 1996
K040435 · ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2
Download PDF FDA Summary Roche Diagnostics Cor…