Cleared Traditional

K012820 - AIA-PACK CTNI 2ND-GEN ASSAY

K012820 is an FDA 510(k) clearance for AIA-PACK CTNI 2ND-GEN ASSAY, manufactured by Tosoh Medics, Inc.. The device is a Class 2 Chemistry device with product code MMI cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K012820 · Tosoh Medics, Inc. · Chemistry device
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Dec 2001
Decision
113d
Days
Class 2
Risk

K012820 is an FDA 510(k) clearance for the AIA-PACK CTNI 2ND-GEN ASSAY. Classified as Immunoassay Method, Troponin Subunit (product code MMI), Class II - Special Controls.

Submitted by Tosoh Medics, Inc. (South San Francisco, US). The FDA issued a Cleared decision on December 14, 2001 after a review of 113 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 Tosoh Medics, Inc. devices

FDA 510(k) Submission Details - K012820

510(k) Number K012820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2001
Decision Date December 14, 2001
Days to Decision 113 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 88d · This submission: 113d
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 K012820.
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
MODIFICATION TO VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/ CALIBRATORS
K020662 · Ortho-Clinical Diagnostics · Apr 2002
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