Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
The Electrophoretic Separation, Alkaline Phosphatase Isoenzymes test system (product code CIN) is an in-vitro diagnostic device used in clinical chemistry to separate and quantify alkaline phosphatase isoenzymes in serum using electrophoretic techniques, providing information about the tissue of origin of elevated alkaline phosphatase activity for liver, bone, and other disease states. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1050 in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.
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Basic Information
- Product Code
- CIN
- Device Class
- FDA class 2
- Regulation Number
- 862.1050
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 26 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K232904 | Access Ostase | Apr 15, 2024 | Substantially Equivalent | Beckman Coulter |
| K200475 | IDS-iSYS Ostase BAP | Sep 30, 2020 | Substantially Equivalent | Immunodiagnostic Systems , Ltd. |
| K043125 | ORION DIAGNOSTICA UNIQ PINP RIA | May 04, 2005 | Substantially Equivalent | Orion Diagnostica, OY |
| K020625 | SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346 | May 06, 2002 | Substantially Equivalent | Helena Laboratories |
| K011113 | HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132) | Jun 13, 2001 | Substantially Equivalent | Sebia |
| K994278 | ACCESS OSTASE IMMUNOENZYMETRIC ASSAY | Mar 28, 2000 | Substantially Equivalent | Beckman Coulter, Inc. |
| K981373 | ALKPHASE-B ASSAY KIT | May 27, 1998 | Substantially Equivalent | Metra Biosystems, Inc. |
| K972666 | TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY | Sep 11, 1997 | Substantially Equivalent | Hybritech, Inc. |
| K964764 | OPUS BONE ALP | Jan 24, 1997 | Substantially Equivalent | Behring Diagnostics, Inc. |
| K961573 | TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY | Aug 19, 1996 | Substantially Equivalent | Hybritech, Inc. |
| K952768 | ALKPHASE-B ASSAY KIT | Aug 24, 1995 | Substantially Equivalent | Metra Biosystems, Inc. |
| K934013 | RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT | Apr 26, 1994 | Substantially Equivalent | Isolab, Inc. |
| K930810 | TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY | Jan 11, 1994 | Substantially Equivalent | Hybritech, Inc. |
| K921578 | TITAN GEL ALKALINE PHOSPHATASE (HR) | Sep 23, 1992 | Substantially Equivalent | Helena Laboratories |
| K912603 | REP ALP-15, 8, & 4 KITS | Jul 30, 1991 | Substantially Equivalent | Helena Laboratories |
| K890269 | ALKALINE PHOSPHATASE ISOENZYME REAGENTS | Mar 08, 1989 | Substantially Equivalent | Beckman Instruments, Inc. |
| K885341 | TITAN GEL ALKALINE PHOSPHATASE (HR) | Feb 23, 1989 | Substantially Equivalent | Helena Laboratories |
| K885024 | ALKALINE PHOSPHATASE ISOENZYME SYSTEM | Feb 17, 1989 | Substantially Equivalent | Ciba Corning Diagnostics Corp. |
| K870890 | ALKALINE PHOSPHATASE INDOLYL BLUE REAGENT | Jun 01, 1987 | Substantially Equivalent | Helena Laboratories |
| K830118 | ALKALINE PHOSPHATES ISOENZYME SUBSTRATE | Feb 25, 1983 | Substantially Equivalent | Corning Medical & Scientific |
| K823445 | ALKPHOR SYSTEM | Dec 28, 1982 | Substantially Equivalent | California Immuno Diagnostic, Inc. |
| K810144 | ALK-PHOS BIOPAK GEL | Feb 02, 1981 | Substantially Equivalent | Bioware Products |
| K792548 | ALKALINE PHOSPHATASE MARKER | Jan 29, 1980 | Substantially Equivalent | Electrophoresis Corp. of America |
| K771620 | ALKALINE PHOSPHATASE ISOENZY. SUB. SET | Sep 15, 1977 | Substantially Equivalent | Pfizer, Inc. |
| K771225 | AP ISOTROL, #A 0140 | Aug 03, 1977 | Substantially Equivalent | Sigma Chemical Co. |
| K760862 | PROCEDURE NO. 710-EP FOR ALK.PHOS. | Nov 02, 1976 | Substantially Equivalent | Sigma Chemical Co. |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.