CIN · Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Clinical Chemistry · 21 CFR 862.1050 · Class 2
Overview
| Product Code | CIN |
|---|---|
| Device Name | Electrophoretic Separation, Alkaline Phosphatase 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.
Cleared Devices (26)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K232904 | Access Ostase | Beckman Coulter | Apr 15, 2024 | SESE |
| K200475 | IDS-iSYS Ostase BAP | Immunodiagnostic Systems , Ltd. | Sep 30, 2020 | SESE |
| K043125 | ORION DIAGNOSTICA UNIQ PINP RIA | Orion Diagnostica, OY | May 4, 2005 | SESE |
| K020625 | SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346 | Helena Laboratories | May 6, 2002 | SESE |
| K011113 | HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132) | Sebia | Jun 13, 2001 | SESE |
| K994278 | ACCESS OSTASE IMMUNOENZYMETRIC ASSAY | Beckman Coulter, Inc. | Mar 28, 2000 | SESE |
| K981373 | ALKPHASE-B ASSAY KIT | Metra Biosystems, Inc. | May 27, 1998 | SESE |
| K972666 | TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY | Hybritech, Inc. | Sep 11, 1997 | SESE |
| K964764 | OPUS BONE ALP | Behring Diagnostics, Inc. | Jan 24, 1997 | SESE |
| K961573 | TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY | Hybritech, Inc. | Aug 19, 1996 | SESE |
| K952768 | ALKPHASE-B ASSAY KIT | Metra Biosystems, Inc. | Aug 24, 1995 | SESE |
| K934013 | RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT | Isolab, Inc. | Apr 26, 1994 | SESE |
| K930810 | TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY | Hybritech, Inc. | Jan 11, 1994 | SESE |
| K921578 | TITAN GEL ALKALINE PHOSPHATASE (HR) | Helena Laboratories | Sep 23, 1992 | SESE |
| K912603 | REP ALP-15, 8, & 4 KITS | Helena Laboratories | Jul 30, 1991 | SESE |
| K890269 | ALKALINE PHOSPHATASE ISOENZYME REAGENTS | Beckman Instruments, Inc. | Mar 8, 1989 | SESE |
| K885341 | TITAN GEL ALKALINE PHOSPHATASE (HR) | Helena Laboratories | Feb 23, 1989 | SESE |
| K885024 | ALKALINE PHOSPHATASE ISOENZYME SYSTEM | Ciba Corning Diagnostics Corp. | Feb 17, 1989 | SESE |
| K870890 | ALKALINE PHOSPHATASE INDOLYL BLUE REAGENT | Helena Laboratories | Jun 1, 1987 | SESE |
| K830118 | ALKALINE PHOSPHATES ISOENZYME SUBSTRATE | Corning Medical & Scientific | Feb 25, 1983 | SESE |
| K823445 | ALKPHOR SYSTEM | California Immuno Diagnostic, Inc. | Dec 28, 1982 | SESE |
| K810144 | ALK-PHOS BIOPAK GEL | Bioware Products | Feb 2, 1981 | SESE |
| K792548 | ALKALINE PHOSPHATASE MARKER | Electrophoresis Corp. of America | Jan 29, 1980 | SESE |
| K771620 | ALKALINE PHOSPHATASE ISOENZY. SUB. SET | Pfizer, Inc. | Sep 15, 1977 | SESE |
| K771225 | AP ISOTROL, #A 0140 | Sigma Chemical Co. | Aug 3, 1977 | SESE |
| K760862 | PROCEDURE NO. 710-EP FOR ALK.PHOS. | Sigma Chemical Co. | Nov 2, 1976 | SESE |
Top Applicants
- Helena Laboratories — 5 clearances
- Hybritech, Inc. — 3 clearances
- Sigma Chemical Co. — 2 clearances
- Metra Biosystems, Inc. — 2 clearances
- Sebia — 1 clearance
