Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
FDA product code CIN · Class II (moderate risk) · 21 CFR 862.1050 · Clinical Chemistry
26510(k) clearances
0PMA approvals
7recalls
Manufacturers
- Helena Laboratories 5
- Hybritech, Inc. 3
- Beckman Coulter Inc. 2
- Metra Biosystems, Inc. 2
- Sigma Chemical Co. 2
- Beckman Instruments, Inc. 1
- Immunodiagnostic Systems , Ltd. 1
- Orion Diagnostica, Inc. 1
- Sebia 1
- Behring Diagnostics, Inc. 1
- Isolab, Inc. 1
- Ciba Corning Diagnostics Corp. 1
- Corning Medical & Scientific 1
- California Immuno Diagnostic, Inc. 1
- Bioware Products 1
- Electrophoresis Corp. of America 1
- Pfizer, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232904 | Access OstaseCIN · Traditional | Beckman Coulter | 04/15/2024SE |
| K200475 | IDS-iSYS Ostase BAPCIN · Traditional | Immunodiagnostic Systems , Ltd. | 09/30/2020SE |
| K043125 | Orion Diagnostica Uniq Pinp RiaCIN · Traditional | Orion Diagnostica, OY | 05/04/2005SE |
| K020625 | Spife 2000/3000 Alp 40, 20; Models 3345 and 3346CIN · Traditional | Helena Laboratories | 05/06/2002SE |
| K011113 | Hydragel Iso-Pal K20 (PN 3022); Hydragel 7 Iso-Pal (PN 4112); Hydragel 15 Iso-Pal (PN…CIN · Traditional | Sebia | 06/13/2001SE |
| K994278 | Access Ostase Immunoenzymetric AssayCIN · Traditional | Beckman Coulter, Inc. | 03/28/2000SE |
| K981373 | Alkphase-B Assay KitCIN · Traditional | Metra Biosystems, Inc. | 05/27/1998SE |
| K972666 | Tandem-Mp Ostase Immunoenzymetric AssayCIN · Traditional | Hybritech, Inc. | 09/11/1997SE |
| K964764 | Opus Bone AlpCIN · Traditional | Behring Diagnostics, Inc. | 01/24/1997SE |
| K961573 | Tandem-R Ostase Immunoradiometric AssayCIN · Traditional | Hybritech, Inc. | 08/19/1996SE |
| K952768 | Alkphase-B Assay KitCIN · Traditional | Metra Biosystems, Inc. | 08/24/1995SE |
| K934013 | Resolve Systems Alkaline Phosphatase Test KitCIN · Traditional | Isolab, Inc. | 04/26/1994SE |
| K930810 | Tandem-R Ostase Immunoradiometric AssayCIN · Traditional | Hybritech, Inc. | 01/11/1994SE |
| K921578 | Titan Gel Alkaline Phosphatase (HR)CIN · Traditional | Helena Laboratories | 09/23/1992SE |
| K912603 | Rep ALP-15, 8, & 4 KitsCIN · Traditional | Helena Laboratories | 07/30/1991SE |
| K890269 | Alkaline Phosphatase Isoenzyme ReagentsCIN · Traditional | Beckman Instruments, Inc. | 03/08/1989SE |
| K885341 | Titan Gel Alkaline Phosphatase (HR)CIN · Traditional | Helena Laboratories | 02/23/1989SE |
| K885024 | Alkaline Phosphatase Isoenzyme SystemCIN · Traditional | Ciba Corning Diagnostics Corp. | 02/17/1989SE |
| K870890 | Alkaline Phosphatase Indolyl Blue ReagentCIN · Traditional | Helena Laboratories | 06/01/1987SE |
| K830118 | Alkaline Phosphates Isoenzyme SubstrateCIN · Traditional | Corning Medical & Scientific | 02/25/1983SE |
| K823445 | Alkphor SystemCIN · Traditional | California Immuno Diagnostic, Inc. | 12/28/1982SE |
| K810144 | Alk-Phos Biopak GelCIN · Traditional | Bioware Products | 02/02/1981SE |
| K792548 | Alkaline Phosphatase MarkerCIN · Traditional | Electrophoresis Corp. of America | 01/29/1980SE |
| K771620 | Alkaline Phosphatase Isoenzy. Sub. SetCIN · Traditional | Pfizer, Inc. | 09/15/1977SE |
| K771225 | Ap Isotrol, #A 0140CIN · Traditional | Sigma Chemical Co. | 08/03/1977SE |
| K760862 | Procedure No. 710-EP for Alk.Phos.CIN · Traditional | Sigma Chemical Co. | 11/02/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1797-2018 Class II | MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline…There is a possibility of low volume and/or leaking standard bottles. | Diagnostic Hybrids, Inc. | 07/14/2016Terminated |
| Z-0044-2013 Class II | IDS-iSYS Intact PINP, Catalog Number IS-4000. Packaged in cardboard Box containing…It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with… | Immunodiagnostics Systems Ltd | 08/10/2012Terminated |
| Z-0041-2013 Class II | IDS-iSYS Ostase BAP (Bone Alkaline Phosphatase) Control Set, Catalog Number IS-2830.…It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with… | Immunodiagnostics Systems Ltd | 08/10/2012Terminated |
| Z-0040-2013 Class II | IDS-iSYS Ostase BAP (Bone Alkaline Phosphatase), Catalog Number IS-2800. Packaged in…It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with… | Immunodiagnostics Systems Ltd | 08/10/2012Terminated |
| Z-1240-2012 | Access Ostase Reagent, Part Number: 37300, subsequent product code: JIS. The Access…The recall was initiated because Beckman confirmed that the Access Ostase Calibrator and QC lots do not meet… | Beckman Coulter Inc. | 11/10/2011Terminated |
| Z-1238-2012 | Access Ostase Calibrators, Part Number: 37305, Subsequent Product Code: JIS. The Access…The recall was initiated because Beckman confirmed that the Access Ostase Calibrator and QC lots do not meet… | Beckman Coulter Inc. | 11/10/2011Terminated |
| Z-1195-2012 | ACCESS Ostase Part Number: 37300 Used for the quantitative measurement of bone alkaline…The Access Ostase reagent lot 021281 shows instability resulting in falsely high patient results. | Beckman Coulter Inc. | 06/22/2011Terminated |