Cleared Traditional

K042477 - VITROS CHEMISTRY PRODUCTS TRFRN REAHENT

Also marketed or referenced as:
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 20 VITROS CHEMISTRY PRODUCTS PROTEIN

K042477 is the FDA 510(k) clearance for VITROS CHEMISTRY PRODUCTS TRFRN REAHENT by Ortho-Clinical Diagnostics, Inc.. It is a Class 2 Chemistry device (product code DDG) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K042477 · Ortho-Clinical Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
67d
Days
Class 2
Risk

K042477 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS TRFRN REAHENT. Classified as Transferrin, Antigen, Antiserum, Control (product code DDG), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on November 19, 2004 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5880 - the FDA in vitro diagnostics and chemistry 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, Inc. devices

Submission Details

510(k) Number K042477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2004
Decision Date November 19, 2004
Days to Decision 67 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 88d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DDG Transferrin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5880
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 Chemistry devices follow this clearance model.

Regulatory Peers - DDG Transferrin, Antigen, Antiserum, Control

All 38
Devices cleared under the same product code (DDG) and FDA review panel - the closest regulatory comparables to K042477.
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K063663 · Dade Behring, Inc. · Mar 2007
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K063322 · Dade Behring, Inc. · Jan 2007
N ANTISERA TO HUMAN TRANSFERRIN
K053075 · Dade Behring, Inc. · Mar 2006
TINA-QUANT TRANSFERRIN VER.2
K012371 · Roche Diagnostics Corp. · Sep 2001
TINA-QUANT TRANSFERRIN VER.2
K012393 · Roche Diagnostics Corp. · Sep 2001
MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL
K011662 · The Binding Site, Ltd. · Jul 2001