Cleared Abbreviated

K012518 - TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113

K012518 is an FDA 510(k) clearance for TRACE SCIENTIFIC ALKALINE PHOSPHATASE, manufactured by Thermo Dma, Inc.. The device is a Class 2 Chemistry device with product code CJE cleared through the Abbreviated 510(k) pathway after a 64-day FDA review.

K012518 · Thermo Dma, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
64d
Days
Class 2
Risk

K012518 is an FDA 510(k) clearance for the TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Thermo Dma, Inc. (Arlington, US). The FDA issued a Cleared decision on October 9, 2001 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1050 - the FDA in vitro diagnostics and chemistry framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Thermo Dma, Inc. devices

FDA 510(k) Submission Details - K012518

510(k) Number K012518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2001
Decision Date October 09, 2001
Days to Decision 64 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 88d · This submission: 64d
Pathway characteristics
Standards-based clearance path.

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 116
Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K012518.
COBAS INTEGRA ALP IFCC GEN.2
K033185 · Roche Diagnostics Corp. · Oct 2003
MODIFICATION TO ALKP
K023807 · Abbott Laboratories · Dec 2002
WIENER LAB. ALP 405
K013983 · Wiener Laboratories Saic · Jan 2002
ALKALINE PHOSPHATASE LIQUID REAGENT
K011599 · Jas Diagnostics, Inc. · Jul 2001
ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30
K003093 · Diagnostic Chemicals , Ltd. · Nov 2000
ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H
K000067 · Teco Diagnostics · Jan 2000