Cleared Traditional

K073191 - ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL

K073191 is an FDA 510(k) clearance for ALKALINE PHOSPHATASE (IFCC) PLUS, manufactured by Thermofisher Scientific OY. The device is a Class 2 Chemistry device with product code CJE cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K073191 · Thermofisher Scientific OY · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
107d
Days
Class 2
Risk

K073191 is an FDA 510(k) clearance for the ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Thermofisher Scientific OY (Vantaa, FI). The FDA issued a Cleared decision on February 28, 2008 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1050 - 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. Standard predicate reliance. 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 Thermofisher Scientific OY devices

FDA 510(k) Submission Details - K073191

510(k) Number K073191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2007
Decision Date February 28, 2008
Days to Decision 107 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
19d slower than avg
Panel avg: 88d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CJE Device Classification - Class 2, Special Controls

Product Code CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1050
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 - CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

All 112
Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K073191.
S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE)
K130141 · Hitachi Chemical Diagnostics, Inc. · Mar 2013
ELITTECH CLINICAL SYSTEMS ALP IFCC SL
K113269 · Elitechgroup · Dec 2011
EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS
K101090 · Medica Corp. · May 2011
GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
K060205 · Horiba Abx · Jul 2006
COBAS INTEGRA ALP IFCC GEN.2
K033185 · Roche Diagnostics Corp. · Oct 2003
MODIFICATION TO ALKP
K023807 · Abbott Laboratories · Dec 2002