Cleared Traditional

K981098 - STRATUS CS CARDIAC TROPONIN I TESTPAK

K981098 is the FDA 510(k) clearance for STRATUS CS CARDIAC TROPONIN I TESTPAK by Dade Behring, Inc.. It is a Class 2 Chemistry device (product code MMI) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K981098 · Dade Behring, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
32d
Days
Class 2
Risk

K981098 is an FDA 510(k) clearance for the STRATUS CS CARDIAC TROPONIN I TESTPAK. Classified as Immunoassay Method, Troponin Subunit (product code MMI), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on April 27, 1998 after a review of 32 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 Dade Behring, Inc. devices

Submission Details

510(k) Number K981098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1998
Decision Date April 27, 1998
Days to Decision 32 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
56d faster than avg
Panel avg: 88d · This submission: 32d
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 62
Devices cleared under the same product code (MMI) and FDA review panel - the closest regulatory comparables to K981098.
ELECSYS TROPONIN T STAT TEST
K984105 · Boehringer Mannheim Corp. · Dec 1998
IMMULITE TROPONIN I, MODEL LKTI1 AND LKT15
K983972 · Diagnostic Products Corp. · Dec 1998
CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST
K981882 · Princeton BioMeditech Corp. · Jul 1998
ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM
K974818 · Radiometer America, Inc. · Jan 1998
TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K973616 · Bayer Corp. · Dec 1997
ABBOTT AXSYM TROPONIN-I
K974103 · Abbott Laboratories · Nov 1997