Cleared Special

K040434 - ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2

K040434 is the FDA 510(k) clearance for ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2 by Roche Diagnostics Corp.. It is a Class 2 Immunology device (product code DEW) cleared through the Special 510(k) pathway after a 20-day FDA review.

K040434 · Roche Diagnostics Corp. · Immunology device
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Mar 2004
Decision
20d
Days
Class 2
Risk

K040434 is an FDA 510(k) clearance for the ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2. Classified as Igg, Antigen, Antiserum, Control (product code DEW), 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.

View all Roche Diagnostics Corp. devices

Submission Details

510(k) Number K040434 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
84d faster than avg
Panel avg: 104d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

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 31
Devices cleared under the same product code (DEW) and FDA review panel - the closest regulatory comparables to K040434.
TINA-QUANT IGG GEN.2
K050113 · Roche Diagnostics Corp. · Feb 2005
SPIFE IFE CALIBRATOR AND CONTROL KIT
K010617 · Helena Laboratories · Mar 2001
WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD
K993928 · Wako Chemicals USA, Inc. · Jan 2000
IGG
K983221 · Abbott Laboratories · Nov 1998
IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN
K963974 · Beckman Instruments, Inc. · Mar 1997
SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT
K965108 · Beckman Instruments, Inc. · Mar 1997