510(k) · Cleared
ClearedS40 Clinical Analyzer, S Test IP, S Test UA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alfa Wassermann Diagnostic Technologies, Inc. · CEO Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Cleared on Jun 24, 2008 as substantially equivalent to K931786 (Schiapparelli Biosystems, Inc., 1993) and 2 other predicates after a 327-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Jun 24, 2008
- Review
- 327 days
- Class
- Class I
- Product code
- CEO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K931786 (1993). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK931786 Ace Clinical Chemistry SystemSchiapparelli Biosystems, Inc. · 1993
- This deviceK072141 S40 Clinical Analyzer, S Test IP, S Test UAAlfa Wassermann Diagnostic Technologies, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931786 | Ace Clinical Chemistry System | Schiapparelli Biosystems, Inc. | 1993 | — |
| 0 (this device) | K072141 | S40 Clinical Analyzer, S Test IP, S Test UA | Alfa Wassermann Diagnostic Technologies, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 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 CEO? 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? (3)
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 |
|---|---|---|---|
| * | K931786 | Ace Clinical Chemistry SystemSummary page 1…urers for analyzer/reagent system predicates are: Devices: 11. ACE plus ISE/Clinical Chemistry System ACE Inorganic Phosphorous Reagent (K931786) ACE Uric Acid Reagent (K931786) 2. Olympus AU640 Clinical Chemistry Analyzer… | 1993 |
| * | K961274 | Olympus AU600 Clinical Chemistry AnalyzerSummary page 1…ACE Uric Acid Reagent (K931786) 2. Olympus AU640 Clinical Chemistry Analyzer Inorganic Phosphorous Reagent (K961274) Uric Acid Reagent (K961274) 3. Piccolo® xpress Chemistry Analyzer… | 1996 |
| * | K942782 | Piccolo (TM)Summary page 1…1274) Uric Acid Reagent (K961274) 3. Piccolo® xpress Chemistry Analyzer Inorganic Phosphorous Reagent (K942782) Uric Acid Reagent (K942782) Device The S-Test inorganic phosphorus (IP) reagent cartridge, used… | 1995 |
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?
- 2 of the 3 ancestors have a recall of any class.
- 21 other devices also cite its predicate K931786.
How does its category compare?
All CEO devicesCEO Phosphomolybdate (Colorimetric), Inorganic Phosphorus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · CEO
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · CEO
Too few CEO 510(k)s in any year since 2007 to give a median.
Recalls per year · CEO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CEO
8in 2025
MAUDE reports naming product code CEO, 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 | — | 1 | 13 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 41 |
| 2011 | 1 | — | 0 | 19 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 3 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 1 | 8 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The S-Test Inorganic Phosphorous Reagent is intended for the quantitative determination of inorganic phosphorous concentration in serum or heparin plasma using the S40 Clinical Analyzer. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance. This test is intended for use in clinical laboratories or physician office laboratories. For in…
Read the full statement (145 words)
The S-Test Inorganic Phosphorous Reagent is intended for the quantitative determination of inorganic phosphorous concentration in serum or heparin plasma using the S40 Clinical Analyzer. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The S-Test Uric Acid Reagent is intended for the quantitative determination of uric acid concentration in serum or heparin plasma using the S40 Clinical Analyzer. 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072141 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072141: S40 Clinical Analyzer, S Test IP, S Test UA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072141
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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