510(k) · Cleared
ClearedIDS-iSYS Ostase BAP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immunodiagnostic Systems, Ltd. · CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Cleared on Sep 30, 2020 as substantially equivalent to K972666 (Hybritech, Inc., 1997) after a 217-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Sep 30, 2020
- Review
- 217 days
- Class
- Class II
- Product code
- CIN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K930810 (1994). No later device cites it as a predicate yet.
- Root · 3 generations backK930810 Tandem-R Ostase Immunoradiometric AssayHybritech, Inc. · 1994
- 2 generations backK961573 Tandem-R Ostase Immunoradiometric AssayHybritech, Inc. · 1996
- 1 generation backK972666 Tandem-MP Ostase Immunoenzymetric AssayHybritech, Inc. · 1997
- This deviceK200475 IDS-iSYS Ostase BAPImmunodiagnostic Systems, Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K930810 | Tandem-R Ostase Immunoradiometric Assay | Hybritech, Inc. | 1994 | — |
| −2 | K961573 | Tandem-R Ostase Immunoradiometric Assay | Hybritech, Inc. | 1996 | — |
| −1 | K972666 | Tandem-MP Ostase Immunoenzymetric Assay | Hybritech, Inc. | 1997 | — |
| 0 (this device) | K200475 | IDS-iSYS Ostase BAP | Immunodiagnostic Systems, Ltd. | 2020 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CIN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CIN device
- #1 K232904 Access Ostasescore 7.8 · 3 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K972666 | Tandem-MP Ostase Immunoenzymetric AssaySummary page 5…istribution intended for similar use. We claim equivalency to the currently marketed Tandem-MP Ostase Immunoenzymetric Assay (k972666), commercially known as Ostase® BAP EIA. Device Description The IDS-iSYS Ostase® BAP assay consists of one… | 1997 |
| † | K961573 | Tandem-R Ostase Immunoradiometric Assay | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All CIN devicesCIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · CIN
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CIN
Too few CIN 510(k)s in any year since 2007 to give a median.
Recalls per year · CIN
3in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CIN
1in 2012
MAUDE reports naming product code CIN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 3 | 2 |
| 2012 | 0 | — | 3 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The IDS-iSYS Ostase® BAP assay is an in vitro diagnostic device intended for the quantitative determination of bone-specific alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum on the IDS system. Results are to be used in conjunction with other clinical and laboratory data to aid the clinician in the management of postmenopausal osteoporosis and Paget’s disease.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K200475 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200475: IDS-iSYS Ostase BAP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200475
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026