Cleared Traditional

K872029 - UNI-FAST CREATINE KINASE TEST (CK)

K872029 is the FDA 510(k) clearance for UNI-FAST CREATINE KINASE TEST (CK) by Sclavo, Inc.. It is a Class 2 Chemistry device (product code JHS) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K872029 · Sclavo, Inc. · Chemistry device
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Jun 1987
Decision
22d
Days
Class 2
Risk

K872029 is an FDA 510(k) clearance for the UNI-FAST CREATINE KINASE TEST (CK). Classified as Differential Rate Kinetic Method, Cpk Or Isoenzymes (product code JHS), Class II - Special Controls.

Submitted by Sclavo, Inc. (Wayne, US). The FDA issued a Cleared decision on June 17, 1987 after a review of 22 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 Sclavo, Inc. devices

Submission Details

510(k) Number K872029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1987
Decision Date June 17, 1987
Days to Decision 22 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 88d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 20
Devices cleared under the same product code (JHS) and FDA review panel - the closest regulatory comparables to K872029.
ACCESS CK-MB REAGENTS
K945083 · Bio-Rad Laboratories, Inc. · Nov 1994
ROCHE ISOMUNE- CK
K903025 · Roche Diagnostic Systems, Inc. · Aug 1990
STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
K900806 · Baxter Healthcare Corp · Mar 1990
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CK-MB)
K861387 · Eastman Kodak Company · Jun 1986
DART CK-MB REAGENT SYSTEM
K854708 · Coulter Electronics, Inc. · Dec 1985
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDDE
K820722 · Eastman Kodak Company · Apr 1982