Cleared Traditional

K070971 - MODIFICATION TO SENTINEL CLIN CHEM CAL

K070971 is the FDA 510(k) clearance for MODIFICATION TO SENTINEL CLIN CHEM CAL by Sentinel Ch. Srl. It is a Class 2 Chemistry device (product code JIX) cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K070971 · Sentinel Ch. Srl · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
47d
Days
Class 2
Risk

K070971 is an FDA 510(k) clearance for the MODIFICATION TO SENTINEL CLIN CHEM CAL. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Sentinel Ch. Srl (Milan, IT). The FDA issued a Cleared decision on May 23, 2007 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 Sentinel Ch. Srl devices

Submission Details

510(k) Number K070971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2007
Decision Date May 23, 2007
Days to Decision 47 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
41d faster than avg
Panel avg: 88d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIX Calibrator, Multi-analyte Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIX Calibrator, Multi-analyte Mixture

All 202
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K070971.
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160
K080607 · Roche Diagnostics Corp. · May 2008
DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H
K072435 · Dade Behring, Inc. · Oct 2007
VITROS CHEMISTRY PRODUCTS CI-SLIDES, CALIBRATOR KIT 2, MODEL(S) 844-5207, 166-2659
K071801 · Ortho-Clinical Diagnostics, Inc. · Jul 2007
MULTI-ANALYTE CHEMISTRY CALIBRATOR
K070207 · Pointe Scientific, Inc., · Apr 2007
DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H
K063508 · Dade Behring, Inc. · Jan 2007
DIMENSION VISTA RF FLEX REAGENT CARTRIDGE
K062035 · Dade Behring, Inc. · Oct 2006