510(k) · Cleared
ClearedAcid Phosphatase Assay for the Advia 1650
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Diagnostics Corp. · CKB Acid Phosphatase, Naphthyl Phosphate
Cleared on Jan 7, 2003 after a 50-day review. The FDA summary names no predicate by number. 6 later devices descend from it.
- Decided
- Jan 7, 2003
- Review
- 50 days
- Class
- Class II
- Product code
- CKB
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK023840 Acid Phosphatase Assay for the Advia 1650Bayer Diagnostics Corp. · 2003
- Descendant · cites it directly · 3 of its ownK030801 Bayer Advia 1650 Special Chemistry ControlBayer Healthcare, LLC · 2003
- Descendant · 2 generations on · 1 of its ownK033379 Bayer Special Chemistry ControlsBayer Diagnostics Corp. · 2003
- Descendant · cites it directly · 1 of its ownK030804 Bayer Advia 1650 Special Chemistry CalibratorBayer Healthcare, LLC · 2003
- Descendant · 3 generations on · 0 of its ownK061137 Advia Ims Cpsa ControlBayer Healthcare, LLC · 2006
- Descendant · 2 generations on · 0 of its ownK033380 Bayer Special Chemistry CalibratorsBayer Diagnostics Corp. · 2003
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K030801Bayer Advia 1650 Special Chemistry ControlBayer Healthcare, LLC · 2003 · cites it directly3descendants
- K033379Bayer Special Chemistry ControlsBayer Diagnostics Corp. · 2003 · 2 generations on1descendant
- K030804Bayer Advia 1650 Special Chemistry CalibratorBayer Healthcare, LLC · 2003 · cites it directly1descendant
- K061137Advia Ims Cpsa ControlBayer Healthcare, LLC · 2006 · 3 generations on0descendants
- K033380Bayer Special Chemistry CalibratorsBayer Diagnostics Corp. · 2003 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023840 | Acid Phosphatase Assay for the Advia 1650 | Bayer Diagnostics Corp. | 2003 | — |
| +1 | K030801 | Bayer Advia 1650 Special Chemistry Control | Bayer Healthcare, LLC | 2003 | — |
| +2 | K033379 | Bayer Special Chemistry Controls | Bayer Diagnostics Corp. | 2003 | — |
| +1 | K030804 | Bayer Advia 1650 Special Chemistry Calibrator | Bayer Healthcare, LLC | 2003 | — |
| +3 | K061137 | Advia Ims Cpsa Control | Bayer Healthcare, LLC | 2006 | — |
| +2 | K033380 | Bayer Special Chemistry Calibrators | Bayer Diagnostics Corp. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 5 | 0 |
| 2006 | 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 CKB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (6)
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?
- Of its descendants, K030801 (Bayer Healthcare, LLC, 2003) has gone furthest, with 3 descendants of its own.
How does its category compare?
All CKB devicesCKB Acid Phosphatase, Naphthyl Phosphate: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CKB
FDA has decided no CKB device since 2007.
Median 510(k) review, days · CKB
Too few CKB 510(k)s in any year since 2007 to give a median.
Recalls per year · CKB
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CKB
2in 2021
MAUDE reports naming product code CKB, 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 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 1 | 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 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Buyer ADVIA 1650 Acid Phosphatase assay is an in vitro diagnostic devke
intended to quantitatively measure total and non-prostatic acid phosphatase
concentration in human serum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023840 · printed Nov 5, 2026
Cite this page
510(k) Report. “K023840: Acid Phosphatase Assay for the Advia 1650.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K023840
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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