Cleared Traditional

K012359 - TINA-QUANT COMPLEMENT C4 TEST SYSTEM

K012359 is the FDA 510(k) clearance for TINA-QUANT COMPLEMENT C4 TEST SYSTEM by Roche Diagnostics Corp.. It is a Class 2 Immunology device (product code DBI) cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K012359 · Roche Diagnostics Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
127d
Days
Class 2
Risk

K012359 is an FDA 510(k) clearance for the TINA-QUANT COMPLEMENT C4 TEST SYSTEM. Classified as Complement C4, Antigen, Antiserum, Control (product code DBI), 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

Submission Details

510(k) Number K012359 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
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 104d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DBI Complement C4, 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 - DBI Complement C4, Antigen, Antiserum, Control

All 15
Devices cleared under the same product code (DBI) and FDA review panel - the closest regulatory comparables to K012359.
WAKO AUTOKIT C4
K010325 · Wako Chemicals USA, Inc. · Jun 2001
RANDOX COMPLEMENT C4
K000468 · Randox Laboratories, Ltd. · Mar 2000
DIMENSION C4 FLEX REAGENT CARTRIDGE
K994293 · Dade Behring, Inc. · Mar 2000
C4 MININEPH ANTISERUM
K981785 · The Binding Site, Ltd. · Dec 1999
C4
K983356 · Abbott Laboratories · Nov 1998
OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT
K962582 · Olympus America, Inc. · Oct 1996