IDS-iSYS Ostase BAP
FDA 510(k) K200475 · Immunodiagnostic Systems , Ltd.
510(k) numberK200475
Submission
- Device name
- IDS-iSYS Ostase BAP
- Applicant
- Immunodiagnostic Systems , Ltd.
Boldon, GB - Received
- February 26, 2020
- Decision date
- September 30, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CIN – Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1050
- Specialty
- Clinical Chemistry
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|---|---|---|---|
| K232904 | Access OstaseCIN · Traditional | Beckman Coulter | 04/15/2024SE |
| 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 |
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| K252728 | IDS-iSYS Total TestosteroneCDZ · Traditional | 04/15/2026SE |
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| K223867 | Ids Acth IICKG · Traditional | 08/18/2023SE |
| K202136 | IDS CortisolCGR · Traditional | 04/13/2021SE |
| K190121 | Ids SHBGCDZ · Traditional | 06/17/2019SE |
| K161158 | IDS-iSYS Intact PTHNCEW · Traditional | 01/31/2017SE |
| K161831 | IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control SetMRG · Traditional | 11/15/2016SE |
| K161082 | IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration VerifiersJJX · Traditional | 05/17/2016SE |
| K142351 | 25-Hydroxy Vitamin Ds EIAMRG · Traditional | 08/25/2015SE |
| K142994 | IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone…CJM · Traditional | 04/21/2015SE |
Questions and answers
When was IDS-iSYS Ostase BAP cleared by the FDA?
IDS-iSYS Ostase BAP (K200475) received a 510(k) decision of Substantially Equivalent on September 30, 2020, 217 days after the submission was received.
What is the product code of K200475?
The FDA product code is CIN – Electrophoretic Separation, Alkaline Phosphatase Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.