Cleared Traditional

K010429 - ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM # 33340, 33345

K010429 is an FDA 510(k) clearance for ACCUTNI AND ACCUTNI CALIBRATORS ON THE ..., manufactured by Beckman Coulter, Inc.. The device is a Class 2 Chemistry device with product code MMI cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K010429 · Beckman Coulter, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
112d
Days
Class 2
Risk

K010429 is an FDA 510(k) clearance for the ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM # 33340, 33345. 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 5, 2001 after a review of 112 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Beckman Coulter, Inc. devices

FDA 510(k) Submission Details - K010429

510(k) Number K010429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2001
Decision Date June 05, 2001
Days to Decision 112 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
24d slower than avg
Panel avg: 88d · This submission: 112d
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 81
Devices cleared under the same product code (MMI) and FDA review panel - the closest regulatory comparables to K010429.
ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL #33340, 33345
K021814 · Beckman Coulter, Inc. · Sep 2002
MODIFICATION TO VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/ CALIBRATORS
K020662 · Ortho-Clinical Diagnostics · Apr 2002
AIA-PACK CTNI 2ND-GEN ASSAY
K012820 · Tosoh Medics, Inc. · Dec 2001
DIMENSION CTNI FLEX REAGENT CARTRIDGE
K010313 · Dade Behring, Inc. · Apr 2001
BAYER ADVIA IMS SYSTEM
K010201 · Bayer Corp. · Mar 2001
THE CARDIAC READER SYSTEM
K000784 · Roche Diagnostics Corp. · May 2000