Cleared Traditional

K000784 - THE CARDIAC READER SYSTEM

K000784 is the FDA 510(k) clearance for THE CARDIAC READER SYSTEM by Roche Diagnostics Corp.. It is a Class 2 Chemistry device (product code MMI) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K000784 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
69d
Days
Class 2
Risk

K000784 is an FDA 510(k) clearance for the THE CARDIAC READER SYSTEM. Classified as Immunoassay Method, Troponin Subunit (product code MMI), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Great Neck,, US). The FDA issued a Cleared decision on May 18, 2000 after a review of 69 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 Roche Diagnostics Corp. devices

Submission Details

510(k) Number K000784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2000
Decision Date May 18, 2000
Days to Decision 69 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
19d faster than avg
Panel avg: 88d · This submission: 69d
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 59
Devices cleared under the same product code (MMI) and FDA review panel - the closest regulatory comparables to K000784.
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
BAYER ADVIA IMS SYSTEM
K010201 · Bayer Corp. · Mar 2001
BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR TROPONIN I ASSAY
K993309 · Bayer Corp. · Dec 1999
TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM ( IN VITRO DIAGNOSTIC SYSTEM)
K993353 · Bayer Corp. · Dec 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK
K992366 · Ortho-Clinical Diagnostics, Inc. · Oct 1999