Cleared Traditional

K033300 - VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLO...

Also marketed or referenced as:
CALIBRATORS RANGE VERIFIERS

K033300 is the FDA 510(k) clearance for VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLO... by Ortho-Clinical Diagnostics, Inc.. It is a Class 2 Chemistry device (product code DDR) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K033300 · Ortho-Clinical Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
22d
Days
Class 2
Risk

K033300 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK. Classified as Myoglobin, Antigen, Antiserum, Control (product code DDR), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on November 5, 2003 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5680 - 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 K033300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2003
Decision Date November 05, 2003
Days to Decision 22 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
66d faster than avg
Panel avg: 88d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DDR Myoglobin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5680
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 - DDR Myoglobin, Antigen, Antiserum, Control

All 32
Devices cleared under the same product code (DDR) and FDA review panel - the closest regulatory comparables to K033300.
ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS
K080481 · Beckman Coulter, Inc. · Feb 2009
TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM
K061683 · Roche Diagnostics Corp. · Jul 2006
QUANTEX MYOGLOBIN
K042982 · Instrumentation Laboratory CO · Dec 2004
MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244
K021229 · Beckman Coulter, Inc. · Jun 2002
RANDOX MYOGLOBIN
K010700 · Randox Laboratories, Ltd. · May 2001
ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316
K000196 · Beckman Coulter, Inc. · Feb 2000