Cleared Traditional

K984359 - AIA-PACK TROPONIN I ASSAY

K984359 is the FDA 510(k) clearance for AIA-PACK TROPONIN I ASSAY by Tosoh Medics, Inc.. It is a Class 2 Chemistry device (product code MMI) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K984359 · Tosoh Medics, Inc. · Chemistry device
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Dec 1998
Decision
16d
Days
Class 2
Risk

K984359 is an FDA 510(k) clearance for the AIA-PACK TROPONIN I 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 23, 1998 after a review of 16 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 Tosoh Medics, Inc. devices

Submission Details

510(k) Number K984359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1998
Decision Date December 23, 1998
Days to Decision 16 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
72d faster than avg
Panel avg: 88d · This submission: 16d
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 68
Devices cleared under the same product code (MMI) and FDA review panel - the closest regulatory comparables to K984359.
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK
K992366 · Ortho-Clinical Diagnostics, Inc. · Oct 1999
OPUS TROPONIN I (CTN) TEST MODULES
K991177 · Dade Behring, Inc. · Jul 1999
IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5
K991795 · Diagnostic Products Corp. · Jun 1999
STRATUS (R) CS CARDIAC TROPONIN I (TROP) TESTPAK
K984093 · Dade Behring, Inc. · Dec 1998
ELECSYS TROPONIN T STAT TEST
K984105 · Boehringer Mannheim Corp. · Dec 1998
IMMULITE TROPONIN I, MODEL LKTI1 AND LKT15
K983972 · Diagnostic Products Corp. · Dec 1998