Cleared Traditional

VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III (K042494) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K042494 · Ortho-Clinical Diagnostics · Immunology device
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Optimized for regulatory review, auditing and printing
Oct 2004
Decision
35d
Days
Class 2
Risk

K042494 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFO.... Classified as Complement C3, Antigen, Antiserum, Control (product code CZW), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on October 19, 2004 after a review of 35 days - a notably fast clearance cycle.

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: 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 Ortho-Clinical Diagnostics devices

Submission Details

510(k) Number K042494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2004
Decision Date October 19, 2004
Days to Decision 35 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
69d faster than avg
Panel avg: 104d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 43
Devices cleared under the same product code (CZW) and FDA review panel - the closest regulatory comparables to K042494.
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K061852 · Dade Behring, Inc. · Sep 2006
N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)
K050665 · Dade Behring, Inc. · May 2005
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K032035 · Beckman Coulter, Inc. · Aug 2003
TINA-QUANT COMPLEMENT C3C TEST SYSTEM
K012361 · Roche Diagnostics Corp. · Nov 2001
DIMENSION C3 FLEX REAGENT CARTRIDGE
K994296 · Dade Behring, Inc. · Mar 2000
C3
K983441 · Abbott Laboratories · Nov 1998