Cleared Traditional

K943024 - KINASE ISOENZYME

K943024 is an FDA 510(k) clearance for KINASE ISOENZYME, manufactured by Dupont Medical Products. The device is a Class 2 Chemistry device with product code JHS cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K943024 · Dupont Medical Products · Chemistry device
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Aug 1994
Decision
68d
Days
Class 2
Risk

K943024 is an FDA 510(k) clearance for the KINASE ISOENZYME. Classified as Differential Rate Kinetic Method, Cpk Or Isoenzymes (product code JHS), Class II - Special Controls.

Submitted by Dupont Medical Products (Wilmington, US). The FDA issued a Cleared decision on August 2, 1994 after a review of 68 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 Dupont Medical Products devices

FDA 510(k) Submission Details - K943024

510(k) Number K943024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1994
Decision Date August 02, 1994
Days to Decision 68 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
20d faster than avg
Panel avg: 88d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHS Device Classification - Class 2, Special Controls

Product Code JHS Differential Rate Kinetic 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 - JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes

All 25
Devices cleared under the same product code (JHS) and FDA review panel - the closest regulatory comparables to K943024.
ACS CKMB II IMMUNOASSAY
K962126 · Ciba Corning Diagnostics Corp. · Jun 1996
STRATUS CK-MB DENDRIMER FLUOROMETRIC ENZYME IMMUNOASSAY & STRATUS CK-MB DENDRIMER HIGH SAMPLE DILUENT
K952250 · Dade Intl., Inc. · Jul 1995
ACCESS CK-MB REAGENTS
K945083 · Bio-Rad Laboratories, Inc. · Nov 1994
CREATINE KINASE METHOD
K941584 · Dupont Medical Products · Jul 1994
ROCHE ISOMUNE- CK
K903025 · Roche Diagnostic Systems, Inc. · Aug 1990
STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
K900806 · Baxter Healthcare Corp · Mar 1990