CJE · Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Clinical Chemistry · 21 CFR 862.1050 · Class 2
Overview
| Product Code | CJE |
|---|---|
| Device Name | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| Regulation | 21 CFR 862.1050 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 124)
Showing 20 most recent of 124 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251074 | Tru Liver Health Test Panel | Truvian Health | Dec 19, 2025 | SESE |
| K240468 | Alkaline Phosphatase | Abbott Laboratories Diagnostics Division | Oct 16, 2024 | SESE |
| K223317 | Alkaline Phosphatase2 | Abbott Ireland Diagnostics Division | Jul 21, 2023 | SESE |
| K191245 | Yumizen C1200 ALP, Yumizen C1200 Albumin | HORIBA ABX SAS | Aug 30, 2019 | SESE |
| K171971 | Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer | Lite-On Technology Corp. H.S.P.B. | Jan 25, 2018 | SESE |
| K171080 | ALP IFCC Gen.2 | Roche Diagnostics Operations (Rdo) | May 10, 2017 | SESE |
| K162275 | Randox RX Daytona Plus Alkaline Phosphatase (ALP) | Randox Laboratories Limited | Apr 21, 2017 | SESE |
| K131351 | ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT | Alfa Wassermann Diagnostic Technologies, LLC | Aug 15, 2013 | SESE |
| K130141 | S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE) | Hitachi Chemical Diagnostics, Inc. | Mar 22, 2013 | SESE |
| K113436 | ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT | Alfa Wassermann | Jul 12, 2012 | SESE |
| K113269 | ELITTECH CLINICAL SYSTEMS ALP IFCC SL | Elitechgroup | Dec 29, 2011 | SESE |
| K101090 | EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS | Medica Corp. | May 20, 2011 | SESE |
| K073191 | ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL | Thermofisher Scientific OY | Feb 28, 2008 | SESE |
| K060205 | GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER | Horiba Abx | Jul 21, 2006 | SESE |
| K033185 | COBAS INTEGRA ALP IFCC GEN.2 | Roche Diagnostics Corp. | Oct 14, 2003 | SESE |
| K023807 | MODIFICATION TO ALKP | Abbott Laboratories | Dec 26, 2002 | SESE |
| K013983 | WIENER LAB. ALP 405 | Wiener Laboratories Saic | Jan 28, 2002 | SESE |
| K012518 | TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113 | Thermo Dma, Inc. | Oct 9, 2001 | SESE |
| K011599 | ALKALINE PHOSPHATASE LIQUID REAGENT | Jas Diagnostics, Inc. | Jul 20, 2001 | SESE |
| K003093 | ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30 | Diagnostic Chemicals , Ltd. | Nov 27, 2000 | SESE |
Top Applicants
- Em Diagnostic Systems, Inc. — 10 clearances
- Abbott Laboratories — 5 clearances
- Harleco — 5 clearances
- J.T. Baker Chemical Co. — 4 clearances
- Sigma Diagnostics, Inc. — 4 clearances
