Cleared Traditional

K012361 - TINA-QUANT COMPLEMENT C3C TEST SYSTEM

K012361 is an FDA 510(k) clearance for TINA-QUANT COMPLEMENT C3C TEST SYSTEM, manufactured by Roche Diagnostics Corp.. The device is a Class 2 Immunology device with product code CZW cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K012361 · Roche Diagnostics Corp. · Immunology device
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Nov 2001
Decision
127d
Days
Class 2
Risk

K012361 is an FDA 510(k) clearance for the TINA-QUANT COMPLEMENT C3C TEST SYSTEM. Classified as Complement C3, Antigen, Antiserum, Control (product code CZW), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on November 29, 2001 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5240 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Roche Diagnostics Corp. devices

FDA 510(k) Submission Details - K012361

510(k) Number K012361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2001
Decision Date November 29, 2001
Days to Decision 127 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
22d slower than avg
Panel avg: 105d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CZW Device Classification - Class 2, Special Controls

Product Code CZW Complement C3, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5240
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 - CZW Complement C3, Antigen, Antiserum, Control

All 35
Devices cleared under the same product code (CZW) and FDA review panel - the closest regulatory comparables to K012361.
N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)
K050665 · Dade Behring, Inc. · May 2005
VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III
K042494 · Ortho-Clinical Diagnostics · Oct 2004
SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI
K032035 · Beckman Coulter, Inc. · Aug 2003
WAKO AUTOKIT C3
K010326 · Wako Chemicals USA, Inc. · Jun 2001
RANDOX COMPLEMENT C3
K000469 · Randox Laboratories, Ltd. · Mar 2000
DIMENSION C3 FLEX REAGENT CARTRIDGE
K994296 · Dade Behring, Inc. · Mar 2000