Cleared Traditional

TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM (K053020) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K053020 · Bayer Healthcare, LLC · Chemistry device
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Dec 2005
Decision
65d
Days
Class 2
Risk

K053020 is an FDA 510(k) clearance for the TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM. Classified as Immunoassay Method, Troponin Subunit (product code MMI), Class II - Special Controls.

Submitted by Bayer Healthcare, LLC (Tarrytown, US). The FDA issued a Cleared decision on December 30, 2005 after a review of 65 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 Bayer Healthcare, LLC devices

Submission Details

510(k) Number K053020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2005
Decision Date December 30, 2005
Days to Decision 65 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 88d · This submission: 65d
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 56
Devices cleared under the same product code (MMI) and FDA review panel - the closest regulatory comparables to K053020.
DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE
K063756 · Dade Behring, Inc. · Mar 2007
ABBOTT AXSYM TROPONIN-I ADV
K060875 · Abbott Laboratories · Jun 2006
DIMENSION VISTA CTNI FLEX FLEX REAGENT CARTRIDGE, CALIBRATOR AND SDIL SAMPLE DILUENT
K053577 · Dade Behring, Inc. · Apr 2006
ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME)
K051752 · Roche Diagnostics · Jul 2005
ABBOTT AXSYM TROPONIN-I ADV
K041811 · Abbott Laboratories · Sep 2004
ELECSYS TROPONIN T STAT TEST
K040733 · Roche Diagnostics Corp. · May 2004