Cleared Traditional

K972782 - DADE STRATUS CK-MB FLUOROMETRIC ENZYME ...

K972782 is the FDA 510(k) clearance for DADE STRATUS CK-MB FLUOROMETRIC ENZYME ... by Dade Intl., Inc.. It is a Class 2 Chemistry device (product code JHX) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K972782 · Dade Intl., Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
21d
Days
Class 2
Risk

K972782 is an FDA 510(k) clearance for the DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY. Classified as Fluorometric Method, Cpk Or Isoenzymes (product code JHX), Class II - Special Controls.

Submitted by Dade Intl., Inc. (Newark, US). The FDA issued a Cleared decision on August 15, 1997 after a review of 21 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 K972782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1997
Decision Date August 15, 1997
Days to Decision 21 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
67d faster than avg
Panel avg: 88d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHX Fluorometric Method, Cpk Or Isoenzymes
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 - JHX Fluorometric Method, Cpk Or Isoenzymes

All 30
Devices cleared under the same product code (JHX) and FDA review panel - the closest regulatory comparables to K972782.
STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK
K984067 · Dade Behring, Inc. · Jan 1999
STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK
K981099 · Dade Behring, Inc. · May 1998
TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAGE MYOGLOBIN, TRIAGE TROPONIN-I AND CK-MB, TRIAGE TROPONIN-I
K973126 · Biosite Incorporated · Oct 1997
VIDAS CREATINE KINASE MB ASSAY 30-421
K962549 · Biomerieux Vitek, Inc. · Aug 1996
CIBA CORNING ACS CKMB IMMUNOASSAY
K911121 · Ciba Corning Diagnostics Corp. · Apr 1991
BIOTROL CK MONOEACTIF
K881267 · Biotrol, USA, Inc. · May 1988