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)
Optimized for regulatory review, auditing and printing
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 35
Devices cleared under the same product code (JHS) and FDA review panel - the closest regulatory comparables to K102706.
Creatine Kinase
K160570 · Roche Diagnostics Operations (Rdo) · May 2016
S40 CREATINE KINASE (CK)
K082226 · Alfa Wassermann Diagnostic Technologies, Inc. · Sep 2008
THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS
K062128 · Dade Behring, Inc. · Aug 2006
CARESIDE CKMB
K990434 · Careside, Inc. · Apr 1999
CARESIDE CK
K990439 · Careside, Inc. · Apr 1999
IMMULITE CK-MB, CATALOG # LKCP1 (100 TESTS), LKCP5 (500 TESTS)
K981495 · Diagnostic Products Corp. · Jun 1998