Cleared Traditional

K102706 - CKMB UDR ASSAY

K102706 is an FDA 510(k) clearance for CKMB UDR ASSAY, manufactured by SENTINEL CH. SpA. The device is a Class 2 Chemistry device with product code JHS cleared through the Traditional 510(k) pathway after a 333-day FDA review.

K102706 · SENTINEL CH. SpA · Chemistry device
Download Printable Device Report (PDF)
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Aug 2011
Decision
333d
Days
Class 2
Risk

K102706 is an FDA 510(k) clearance for the CKMB UDR ASSAY. Classified as Differential Rate Kinetic Method, Cpk Or Isoenzymes (product code JHS), Class II - Special Controls.

Submitted by SENTINEL CH. SpA (Milan, IT). The FDA issued a Cleared decision on August 19, 2011 after a review of 333 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all SENTINEL CH. SpA devices

FDA 510(k) Submission Details - K102706

510(k) Number K102706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2010
Decision Date August 19, 2011
Days to Decision 333 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
245d slower than avg
Panel avg: 88d · This submission: 333d
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 26
Devices cleared under the same product code (JHS) and FDA review panel - the closest regulatory comparables to K102706.
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
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
KINASE ISOENZYME
K943024 · Dupont Medical Products · Aug 1994