Cleared Traditional

K082226 - S40 CREATINE KINASE (CK)

K082226 is the FDA 510(k) clearance for S40 CREATINE KINASE (CK) by Alfa Wassermann Diagnostic Technologies, Inc.. It is a Class 2 Chemistry device (product code JHS) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K082226 · Alfa Wassermann Diagnostic Technologies, Inc. · Chemistry device
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Sep 2008
Decision
42d
Days
Class 2
Risk

K082226 is an FDA 510(k) clearance for the S40 CREATINE KINASE (CK). Classified as Differential Rate Kinetic Method, Cpk Or Isoenzymes (product code JHS), Class II - Special Controls.

Submitted by Alfa Wassermann Diagnostic Technologies, Inc. (West Caldwell, US). The FDA issued a Cleared decision on September 18, 2008 after a review of 42 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 Alfa Wassermann Diagnostic Technologies, Inc. devices

Submission Details

510(k) Number K082226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2008
Decision Date September 18, 2008
Days to Decision 42 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
46d faster than avg
Panel avg: 88d · This submission: 42d
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 21
Devices cleared under the same product code (JHS) and FDA review panel - the closest regulatory comparables to K082226.
THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS
K062128 · Dade Behring, Inc. · Aug 2006
IMMULITE CK-MB, CATALOG # LKCP1 (100 TESTS), LKCP5 (500 TESTS)
K981495 · Diagnostic Products Corp. · Jun 1998
ACS CKMB II IMMUNOASSAY
K962126 · Ciba Corning Diagnostics Corp. · Jun 1996
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