Cleared Traditional

K050113 - TINA-QUANT IGG GEN.2

K050113 is the FDA 510(k) clearance for TINA-QUANT IGG GEN.2 by Roche Diagnostics Corp.. It is a Class 2 Immunology device (product code DEW) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K050113 · Roche Diagnostics Corp. · Immunology device
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Feb 2005
Decision
21d
Days
Class 2
Risk

K050113 is an FDA 510(k) clearance for the 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 February 8, 2005 after a review of 21 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 Roche Diagnostics Corp. devices

Submission Details

510(k) Number K050113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2005
Decision Date February 08, 2005
Days to Decision 21 days
Submission Type Traditional
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
83d faster than avg
Panel avg: 104d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K050113.
ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2
K040434 · Roche Diagnostics Corp. · Mar 2004
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