510(k) · Cleared
Recalled · Class II · 2016Access Ostase Immunoenzymetric Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Cleared on Mar 28, 2000 as substantially equivalent to K961573 (Hybritech, Inc., 1996) after a 99-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it. It has been recalled 6 times.
- Decided
- Mar 28, 2000
- Review
- 99 days
- Class
- Class II
- Product code
- CIN
- Recalls
- 6
- Predicates
- 1
Its longest line of descent runs back 2 generations to K930810 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK930810 Tandem-R Ostase Immunoradiometric AssayHybritech, Inc. · 1994
- 1 generation backK961573 Tandem-R Ostase Immunoradiometric AssayHybritech, Inc. · 1996
- This deviceK994278 Access Ostase Immunoenzymetric AssayBeckman Coulter, Inc. · 2000
- Descendant · cites it directly · 0 of its ownK232904 Access OstaseBeckman Coulter · 2024
Most influential descendants
Showing 1 of 1 · See all- K232904Access OstaseBeckman Coulter · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930810 | Tandem-R Ostase Immunoradiometric Assay | Hybritech, Inc. | 1994 | — |
| −1 | K961573 | Tandem-R Ostase Immunoradiometric Assay | Hybritech, Inc. | 1996 | — |
| 0 (this device) | K994278 | Access Ostase Immunoenzymetric Assay | Beckman Coulter, Inc. | 2000 | — |
| +1 | K232904 | Access Ostase | Beckman Coulter | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K961573 | Tandem-R Ostase Immunoradiometric AssaySummary page 1…test system. PREDICATE DEVICE Beckman Coulter Predicate Predicate Company Docket Product Number Access® Ostase® Tandem®-R Assay Ostase® Assay Beckman Coulter, Inc. K961573 5.0 DESCRIPTION OF THE DEVICE The Access Ostase Assay is a paramagnetic particle, chemiluminescent immunoassay for use with t… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232904 | Access Ostase | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 24, 2016 | Class II | Z-0407-2017 | Under Investigation by firm | Beckman Coulter has determined that the Access Ostase Calibrator and Access Ostase QC lots do not meet their expiration date claims within the 10% criteria. |
| Oct 24, 2016 | Class II | Z-0408-2017 | Under Investigation by firm | Beckman Coulter has determined that the Access Ostase Calibrator and Access Ostase QC lots do not meet their expiration date claims within the 10% criteria. |
| Nov 10, 2011 | Not classified | Z-1238-2012 | Process design | The recall was initiated because Beckman confirmed that the Access Ostase Calibrator and QC lots do not meet expiration date claims. The Access Ostase Reagent Kit lots identified were quality control tested and released using Access… |
| Nov 10, 2011 | Not classified | Z-1240-2012 | Process design | The recall was initiated because Beckman confirmed that the Access Ostase Calibrator and QC lots do not meet expiration date claims. The Access Ostase Reagent Kit lots identified were quality control tested and released using Access… |
| Jun 22, 2011 | Not classified | Z-1195-2012 | Process design | The Access Ostase reagent lot 021281 shows instability resulting in falsely high patient results. |
| May 10, 2011 | Not classified | Z-2605-2011 | Package design/selection | The recall was initiated because Beckman Coulter has confirmed that Access Ostase Calibrator and QC vials from the affected lots have shown an increased rate of fracturing and may leak the contents in the box during shipment to customers.… |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K232904 (Beckman Coulter, 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K961573.
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?
Beckman Coulter, Inc's Access Ostase Assay is a paramagnetic particle,
chemiluminescent immunoassay for use with the Access Immunoassay System
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994278 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994278: Access Ostase Immunoenzymetric Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994278
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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