510(k) · Cleared
ClearedAccess Ostase
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter · CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Cleared on Apr 15, 2024 as substantially equivalent to K994278 (Beckman Coulter, Inc., 2000) after a 210-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Apr 15, 2024
- Review
- 210 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 backK994278 Access Ostase Immunoenzymetric AssayBeckman Coulter, Inc. · 2000 · Recalled
- This deviceK232904 Access OstaseBeckman Coulter · 2024
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 | K994278 | Access Ostase Immunoenzymetric Assay | Beckman Coulter, Inc. | 2000 | 6 |
| 0 (this device) | K232904 | Access Ostase | Beckman Coulter | 2024 | — |
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 K200475 IDS-iSYS Ostase BAPscore 0.7 · 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 |
|---|---|---|---|
| * | K994278 | Access Ostase Immunoenzymetric AssaySummary page 4…kaline phosphatase or isoenzymes test system. Classification Regulation: [21 CFR 862.1050] Product Code: CIN Predicate Device Device Name: Access Ostase 510(k) Numbers: k994278 Device Description The Access Ostase assay is a one-step sandwich immunoenzymatic assay. The Access Ostase assay consists of th… | 2000 |
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 30 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
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. 2024, 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 Access Ostase assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access Immunoassay Systems for the quantitative measurement of bone alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum and plasma. This device is intended to be used as an aid in the management of postmenopausal osteoporosis and Paget's disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232904 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232904: Access Ostase.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232904
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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