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 Jan 11, 1994 after a 328-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jan 11, 1994
- Review
- 328 days
- Class
- Class II
- Product code
- CIN
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK930810 Tandem-R Ostase Immunoradiometric AssayHybritech, Inc. · 1994
- Descendant · cites it directly · 4 of its ownK961573 Tandem-R Ostase Immunoradiometric AssayHybritech, Inc. · 1996
- Descendant · 2 generations on · 1 of its ownK994278 Access Ostase Immunoenzymetric AssayBeckman Coulter, Inc. · 2000 · Recalled
- Descendant · 2 generations on · 1 of its ownK972666 Tandem-MP Ostase Immunoenzymetric AssayHybritech, Inc. · 1997
- Descendant · 3 generations on · 0 of its ownK232904 Access OstaseBeckman Coulter · 2024
- Descendant · 3 generations on · 0 of its ownK200475 IDS-iSYS Ostase BAPImmunodiagnostic Systems, Ltd. · 2020
Most influential descendants
Showing 5 of 5 · See all- K961573Tandem-R Ostase Immunoradiometric AssayHybritech, Inc. · 1996 · cites it directly4descendants
- K994278Access Ostase Immunoenzymetric AssayBeckman Coulter, Inc. · 2000 · 2 generations on1descendant
- K972666Tandem-MP Ostase Immunoenzymetric AssayHybritech, Inc. · 1997 · 2 generations on1descendant
- K232904Access OstaseBeckman Coulter · 2024 · 3 generations on0descendants
- K200475IDS-iSYS Ostase BAPImmunodiagnostic Systems, Ltd. · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K930810 | Tandem-R Ostase Immunoradiometric Assay | Hybritech, Inc. | 1994 | — |
| +1 | K961573 | Tandem-R Ostase Immunoradiometric Assay | Hybritech, Inc. | 1996 | — |
| +2 | K994278 | Access Ostase Immunoenzymetric Assay | Beckman Coulter, Inc. | 2000 | 6 |
| +2 | K972666 | Tandem-MP Ostase Immunoenzymetric Assay | Hybritech, Inc. | 1997 | — |
| +3 | K232904 | Access Ostase | Beckman Coulter | 2024 | — |
| +3 | K200475 | IDS-iSYS Ostase BAP | Immunodiagnostic Systems, Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K961573 | Tandem-R Ostase Immunoradiometric Assay | 1996 | 4 |
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?
- Of its descendants, K961573 (Hybritech, Inc., 1996) has gone furthest, with 4 descendants 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 | — |
https://510kreport.com/device/K930810 · printed Nov 6, 2026
Cite this page
510(k) Report. “K930810: Tandem-R Ostase Immunoradiometric Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K930810
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026