510(k) · Cleared
ClearedAce CK Reagent,Ace Bun/Urea Reagent,Ace Uric Acid Reagent,Ace Creatinine Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alfa Wassermann Diagnostic Technologies, Inc. · CDN Urease, Photometric, Urea Nitrogen
Cleared on Aug 10, 2012 as substantially equivalent to K930104 (Schiapparelli Biosystems, Inc., 1993) after a 268-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Aug 10, 2012
- Review
- 268 days
- Class
- Class II
- Product code
- CDN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K930104 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK930104 Ace Clinical Chemistry SystemSchiapparelli Biosystems, Inc. · 1993 · Recalled
- This deviceK113389 Ace CK Reagent,Ace Bun/Urea Reagent,Ace Uric Acid Reagent,Ace…Alfa Wassermann Diagnostic Technologies, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930104 | Ace Clinical Chemistry System | Schiapparelli Biosystems, Inc. | 1993 | 1 |
| 0 (this device) | K113389 | Ace CK Reagent,Ace Bun/Urea Reagent,Ace Uric Acid Reagent,Ace Creatinine Reagent | Alfa Wassermann Diagnostic Technologies, Inc. | 2012 | — |
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 CDN? 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 |
|---|---|---|---|
| * | K930104 | Ace Clinical Chemistry SystemSummary page 2…em predicate: Devices: Alfa Wassermann ACE Clinical Chemistry System. Calibrators. Chemistry Controls, plus 12 ACE Reagents (K930 104) Device The ACE Axcel Clinical Chemistry System consists of two major Descriptions: components,… | 1993 |
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 a recall.
- 6 other devices also cite its predicate K930104.
How does its category compare?
All CDN devicesCDN Urease, Photometric, Urea Nitrogen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · CDN
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · CDN
Too few CDN 510(k)s in any year since 2007 to give a median.
Recalls per year · CDN
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CDN
2in 2015
MAUDE reports naming product code CDN, 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 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 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 ACE BUN/Urea Reagent is intended for the quantitative determination of blood urea nitrogen (BUN) concentration in serum using the ACE Axcel Clinical Chemistry System. BUN measurements are used in the diagnosis and treatment of certain renal and metabolic diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. The ACE Creatinine Reagent is intended for the quantitative…
Read the full statement (267 words)
The ACE BUN/Urea Reagent is intended for the quantitative determination of blood urea nitrogen (BUN) concentration in serum using the ACE Axcel Clinical Chemistry System. BUN measurements are used in the diagnosis and treatment of certain renal and metabolic diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE Creatinine Reagent is intended for the quantitative determination of creatinine concentration in serum using the ACE Mxcel Clinical Chemistry System. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE Uric Acid Reagent is intended for the quantitative determination of uric acid concentration in serum using the ACE Axcel Clinical Chemistry System. Uric acid measurements are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions and of patients receiving cytotoxic drugs. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE CK Reagent is intended for the quantitative determination of creatine kinase activity in serum using the ACE Axel Clinical Chemistry System. Measurement of creatine kinase is used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113389 · printed Nov 4, 2026
Cite this page
510(k) Report. “K113389: Ace CK Reagent,Ace Bun/Urea Reagent,Ace Uric Acid Reagent,Ace Creatinine Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K113389
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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