Cleared Traditional

K951890 - STRATUS CARDIAC TROPONIN-I FLUOROMETRIC...

K951890 is the FDA 510(k) clearance for STRATUS CARDIAC TROPONIN-I FLUOROMETRIC... by Dade Intl., Inc.. It is a Class 2 Chemistry device (product code MMI) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K951890 · Dade Intl., Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
80d
Days
Class 2
Risk

K951890 is an FDA 510(k) clearance for the STRATUS CARDIAC TROPONIN-I FLUOROMETRIC ENZYME IMMUNMNOASSAY & STRATUS CARDIA.... Classified as Immunoassay Method, Troponin Subunit (product code MMI), Class II - Special Controls.

Submitted by Dade Intl., Inc. (Miami, US). The FDA issued a Cleared decision on July 13, 1995 after a review of 80 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 Intl., Inc. devices

Submission Details

510(k) Number K951890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1995
Decision Date July 13, 1995
Days to Decision 80 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 88d · This submission: 80d
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 69
Devices cleared under the same product code (MMI) and FDA review panel - the closest regulatory comparables to K951890.
BOEHRINGER MANNHEIM CARDIAC T TROPNIN T
K955868 · Boehringer Mannheim Corp. · Feb 1996
OPUS TROPONIN I
K955284 · Behring Diagnostics, Inc. · Jan 1996
BOEHRINGER MANNHEIM CARDIAC T TROPONIN T RAPID ASSAY
K952478 · Boehringer Mannheim Corp. · Nov 1995
CARDIAC T ELISA TROPONIN-T
K924392 · Boehringer Mannheim Corp. · Apr 1994