510(k) · Cleared
ClearedS40 Clinical Analyzer, S Test Alb
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alfa Wassermann Diagnostic Technologies, Inc. · CIX Bromcresol Green Dye-Binding, Albumin
Cleared on Jul 14, 2008 as substantially equivalent to K931786 (Schiapparelli Biosystems, Inc., 1993) and 2 other predicates after a 347-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Jul 14, 2008
- Review
- 347 days
- Class
- Class II
- Product code
- CIX
- 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 deviceK072143 S40 Clinical Analyzer, S Test AlbAlfa 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) | K072143 | S40 Clinical Analyzer, S Test Alb | 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 CIX? 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 CIX device
- #1 K251157 Core Metabolicscore 10.9 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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…acturers for analyzer/reagent system predicates are: Devices: 1. ACE plus ISE/ Clinical Chemistry System ACE Albumin Reagent (K931786) 2. Olympus AU640 Clinical Chemistry Analyzer Albumin Reagent (K961274)… | 1993 |
| * | K961274 | Olympus AU600 Clinical Chemistry AnalyzerSummary page 1…ACE Albumin Reagent (K931786) 2. Olympus AU640 Clinical Chemistry Analyzer Albumin Reagent (K961274) 3. Piccolo® xpress Chemistry Analyzer Albumin Reagent (K942782) Device… | 1996 |
| * | K942782 | Piccolo (TM)Summary page 1…alyzer Albumin Reagent (K961274) 3. Piccolo® xpress Chemistry Analyzer Albumin Reagent (K942782) Device The S-Test albumin (ALB) reagent cartridge used with the S40 Clinical Description: Analyzer is intended… | 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 CIX devicesCIX Bromcresol Green Dye-Binding, Albumin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · CIX
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · CIX
168in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CIX
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CIX
4in 2025
MAUDE reports naming product code CIX, 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 | 1 | — | 0 | 1 |
| 2008 | 1 | — | 1 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 74 |
| 2011 | 3 | 168 | 0 | 8 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 1 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 1 | — | 0 | 2 |
| 2019 | 1 | — | 1 | 0 |
| 2020 | 0 | — | 1 | 1 |
| 2021 | 2 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The S-Test Albumin Reagent is intended for the quantitative determination of albumin concentration in serum or heparin plasma using the S40 Clinical Analyzer. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. 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/K072143 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072143: S40 Clinical Analyzer, S Test Alb.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072143
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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