Cleared Traditional

K020662 - MODIFICATION TO VITROS IMMUNODIAGNOSTIC...

K020662 is the FDA 510(k) clearance for MODIFICATION TO VITROS IMMUNODIAGNOSTIC... by Ortho-Clinical Diagnostics. It is a Class 2 Chemistry device (product code MMI) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K020662 · Ortho-Clinical Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
42d
Days
Class 2
Risk

K020662 is an FDA 510(k) clearance for the MODIFICATION TO VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/ CAL.... Classified as Immunoassay Method, Troponin Subunit (product code MMI), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on April 12, 2002 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1215 - 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 devices

Submission Details

510(k) Number K020662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2002
Decision Date April 12, 2002
Days to Decision 42 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
46d faster than avg
Panel avg: 88d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MMI Immunoassay Method, Troponin Subunit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1215
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 - MMI Immunoassay Method, Troponin Subunit

All 68
Devices cleared under the same product code (MMI) and FDA review panel - the closest regulatory comparables to K020662.
MODIFICATION TO VITROS IMMUNDODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/CALIBRATORS
K024193 · Ortho-Clinical Diagnostics · Feb 2003
LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST
K022946 · Princeton BioMeditech Corp. · Oct 2002
ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL #33340, 33345
K021814 · Beckman Coulter, Inc. · Sep 2002
AIA-PACK CTNI 2ND-GEN ASSAY
K012820 · Tosoh Medics, Inc. · Dec 2001
ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM # 33340, 33345
K010429 · Beckman Coulter, Inc. · Jun 2001
DIMENSION CTNI FLEX REAGENT CARTRIDGE
K010313 · Dade Behring, Inc. · Apr 2001