510(k) · Cleared
ClearedDri-Stat Acid Phosphatase Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · CKB Acid Phosphatase, Naphthyl Phosphate
Cleared on Apr 26, 2006 as substantially equivalent to K821674 (Smithkline Diagnostics, Inc., 1982) after a 120-day review. Its family tree reaches back 1 generation to 1982.
- Decided
- Apr 26, 2006
- Review
- 120 days
- Class
- Class II
- Product code
- CKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K821674 (1982). No later device cites it as a predicate yet.
- Root · 1 generation backK821674 Spinchem Acid Phosphatase ReagentSmithkline Diagnostics, Inc. · 1982
- This deviceK053612 Dri-Stat Acid Phosphatase ReagentBeckman Coulter, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K821674 | Spinchem Acid Phosphatase Reagent | Smithkline Diagnostics, Inc. | 1982 | — |
| 0 (this device) | K053612 | Dri-Stat Acid Phosphatase Reagent | Beckman Coulter, Inc. | 2006 | — |
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? (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 |
|---|---|---|---|
| * | K821674 | Spinchem Acid Phosphatase ReagentSummary page 1…cket Number Dri-STAT® Reagent Dri-STAT® Reagent Beckman K821674 ACP on Synchron ACP On Cobas Coulter, Inc.* Systems Fara *Beck… | 1982 |
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?
- Its one ancestor has no recall.
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?
Dri-STAT' Reagent ACP is intended for use in the in vitro diagnostic determination of total acid phosphatase and non-prostatic acid phosphatase in human serum as a User Defined Reagent (UDR) application on SYNCHRON® Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053612 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053612: Dri-Stat Acid Phosphatase Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053612
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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