Cleared Traditional

K121214 - ACCESS ACCUTNI+3 REAGENT AND ACCESS ACC...

K121214 is the FDA 510(k) clearance for ACCESS ACCUTNI+3 REAGENT AND ACCESS ACC... by Beckman Coulter, Inc.. It is a Class 2 Chemistry device (product code MMI) cleared through the Traditional 510(k) pathway after a 417-day FDA review.

K121214 · Beckman Coulter, Inc. · Chemistry device
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Jun 2013
Decision
417d
Days
Class 2
Risk

K121214 is an FDA 510(k) clearance for the ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCE.... Classified as Immunoassay Method, Troponin Subunit (product code MMI), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on June 14, 2013 after a review of 417 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Beckman Coulter, Inc. devices

Submission Details

510(k) Number K121214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2012
Decision Date June 14, 2013
Days to Decision 417 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
329d slower than avg
Panel avg: 88d · This submission: 417d
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 K121214.
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K172783 · Beckman Coulter, Inc. · Jun 2018
Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5
K162895 · Roche Diagnostics · Jan 2017
ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
K121790 · Beckman Coulter, Inc. · Sep 2013
ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS
K082699 · Roche Diagnostics · Aug 2009
DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692
K081643 · Siemens Healthcare Diagnostics · Jul 2008
VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448
K063243 · bioMerieux, Inc. · Dec 2007