Cleared Traditional

K020662 - MODIFICATION TO VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/ CALIBRATORS

K020662 is an FDA 510(k) clearance for MODIFICATION TO VITROS IMMUNODIAGNOSTIC..., manufactured by Ortho-Clinical Diagnostics. The device is a Class 2 Chemistry device with 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) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K020662

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
47d faster than avg
Panel avg: 89d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MMI Device Classification - Class 2, Special Controls

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 94
Devices cleared under the same product code (MMI) and FDA review panel - the closest regulatory comparables to K020662.
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
SPECTRAL'S 2 IN 1 (TNI-MYO)
K020950 · Spectral Diagnostics, Inc. · May 2002
SPECTRAL'S TROPONIN I
K014105 · Spectral Diagnostics, Inc. · Feb 2002
BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT
K013062 · Biocheck, Inc. · Jan 2002
MODIFICATION TO ALPHA DX SYSTEM
K014024 · First Medical, Inc. · Dec 2001
K020662 · MODIFICATION TO VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/ CALIBRATORS
Download PDF FDA Summary Ortho-Clinical Diagno…