510(k) · Cleared
ClearedTandem-R Ostase Immunoradiometric Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hybritech, Inc. · CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Cleared on Aug 19, 1996 as substantially equivalent to K930810 (Hybritech, Inc., 1994) after a 118-day review. Its family tree reaches back 1 generation to 1994. 4 later devices descend from it.
- Decided
- Aug 19, 1996
- Review
- 118 days
- Class
- Class II
- Product code
- CIN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K930810 (1994). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK930810 Tandem-R Ostase Immunoradiometric AssayHybritech, Inc. · 1994
- This deviceK961573 Tandem-R Ostase Immunoradiometric AssayHybritech, Inc. · 1996
- Descendant · cites it directly · 1 of its ownK994278 Access Ostase Immunoenzymetric AssayBeckman Coulter, Inc. · 2000 · Recalled
- Descendant · cites it directly · 1 of its ownK972666 Tandem-MP Ostase Immunoenzymetric AssayHybritech, Inc. · 1997
- Descendant · 2 generations on · 0 of its ownK232904 Access OstaseBeckman Coulter · 2024
- Descendant · 2 generations on · 0 of its ownK200475 IDS-iSYS Ostase BAPImmunodiagnostic Systems, Ltd. · 2020
Most influential descendants
Showing 4 of 4 · See all- K994278Access Ostase Immunoenzymetric AssayBeckman Coulter, Inc. · 2000 · cites it directly1descendant
- K972666Tandem-MP Ostase Immunoenzymetric AssayHybritech, Inc. · 1997 · cites it directly1descendant
- K232904Access OstaseBeckman Coulter · 2024 · 2 generations on0descendants
- K200475IDS-iSYS Ostase BAPImmunodiagnostic Systems, Ltd. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930810 | Tandem-R Ostase Immunoradiometric Assay | Hybritech, Inc. | 1994 | — |
| 0 (this device) | K961573 | Tandem-R Ostase Immunoradiometric Assay | Hybritech, Inc. | 1996 | — |
| +1 | K994278 | Access Ostase Immunoenzymetric Assay | Beckman Coulter, Inc. | 2000 | 6 |
| +1 | K972666 | Tandem-MP Ostase Immunoenzymetric Assay | Hybritech, Inc. | 1997 | — |
| +2 | K232904 | Access Ostase | Beckman Coulter | 2024 | — |
| +2 | K200475 | IDS-iSYS Ostase BAP | Immunodiagnostic Systems, Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
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
- #2 Held for the reportin the report
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 |
|---|---|---|---|
| * | K930810 | Tandem-R Ostase Immunoradiometric AssaySummary page 2…f osteoblastic activity, in human serum is substantially equivalent to the Tandem-R 195 Ostase assay that was cleared by FDA in a previous submission (#K930810). This premarket notification includes clinical data demonstrating that the Tandem-R Ostase assay provides the clinician with in… | 1994 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K994278 (Beckman Coulter, Inc., 2000) has gone furthest, with 1 descendant of its own.
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.
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?
Tandem-R Ostase, as an indicator of osteoblastic activity which is intended to be used as an aid 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/K961573 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961573: Tandem-R Ostase Immunoradiometric Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961573
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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