510(k) · Cleared
ClearedS-Test CA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alfa Wassermann Diagnostic Technologies, Inc. · CJY Azo Dye, Calcium
Cleared on Jun 24, 2008 as substantially equivalent to K931786 (Schiapparelli Biosystems, Inc., 1993) and 2 other predicates after a 307-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Jun 24, 2008
- Review
- 307 days
- Class
- Class II
- Product code
- CJY
- 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 deviceK072356 S-Test CAAlfa 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) | K072356 | S-Test CA | Alfa Wassermann Diagnostic Technologies, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 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 CJY? 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 CJY device
- #1 K244042 Calcium2score 9.4 · 3 generations · no Class I recall
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…Manufacturers for analyzer/reagent system predicates are: Devices: I1. ACE plus ISE/Clinical Chemistry System ACE Calcium Reagent (K931786) 2. Ortho Clinical Diagnostics Fusion Clinical Chemistry Analyzer Calcium Reagent (… | 1993 |
| * | K946090 | Kodak Ektacchem 950IRC AnalyzerSummary page 1…ACE Calcium Reagent (K931786) 2. Ortho Clinical Diagnostics Fusion Clinical Chemistry Analyzer Calcium Reagent (K946090) 3. Piccolos xpress Chemistry Analyzer Calcium Reagent (K942782) Device T… | 1995 |
| * | K942782 | Piccolo (TM)Summary page 1…Chemistry Analyzer Calcium Reagent (K946090) 3. Piccolos xpress Chemistry Analyzer Calcium Reagent (K942782) Device The S-Test Calcium (CA) reagent cartridge, used with the S40 Clinical Description: Analyzer, is intended for… | 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 CJY devicesCJY Azo Dye, Calcium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · CJY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CJY
Too few CJY 510(k)s in any year since 2007 to give a median.
Recalls per year · CJY
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CJY
59in 2025
MAUDE reports naming product code CJY, 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 | 2 | — | 0 | 3 |
| 2008 | 2 | — | 0 | 4 |
| 2009 | 1 | — | 0 | 8 |
| 2010 | 0 | — | 0 | 10 |
| 2011 | 0 | — | 0 | 9 |
| 2012 | 1 | — | 0 | 5 |
| 2013 | 1 | — | 4 | 8 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 1 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 26 |
| 2018 | 1 | — | 2 | 21 |
| 2019 | 1 | — | 0 | 29 |
| 2020 | 0 | — | 0 | 33 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 1 | 17 |
| 2023 | 0 | — | 0 | 29 |
| 2024 | 0 | — | 0 | 34 |
| 2025 | 1 | — | 0 | 59 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The S-Test Calcium Reagent is intended for the quantitative determination of calcium concentration in serum or heparin plasma using the S40 Clinical Analyzer. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease, and tetany (intermittent muscular contractions or spasms). 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/K072356 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072356: S-Test CA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072356
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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