510(k) · Cleared
ClearedS40 Creatine Kinase (CK)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alfa Wassermann Diagnostic Technologies, Inc. · JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes
Cleared on Sep 18, 2008 as substantially equivalent to K931786 (Schiapparelli Biosystems, Inc., 1993) after a 42-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Sep 18, 2008
- Review
- 42 days
- Class
- Class II
- Product code
- JHS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K931786 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK931786 Ace Clinical Chemistry SystemSchiapparelli Biosystems, Inc. · 1993
- This deviceK082226 S40 Creatine Kinase (CK)Alfa 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) | K082226 | S40 Creatine Kinase (CK) | Alfa Wassermann Diagnostic Technologies, Inc. | 2008 | — |
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 JHS? 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 |
|---|---|---|---|
| * | K931786 | Ace Clinical Chemistry SystemSummary page 1…or analyzer/reagent system predicate is: Device: Alfa Wassermnann ACE plus ISE/Clinical Chemistry System ACE Creatine Kinase Reagent (k93 1786) Device The S-Test Creatine Kinase (CK) reagent cartridge, used with the S40 Clinical Description: Analyzer,… | 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 no recall.
- 21 other devices also cite its predicate K931786.
How does its category compare?
All JHS devicesJHS Differential Rate Kinetic Method, Cpk Or Isoenzymes: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · JHS
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JHS
Too few JHS 510(k)s in any year since 2007 to give a median.
Recalls per year · JHS
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JHS
10in 2025
MAUDE reports naming product code JHS, 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 | 1 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 11 |
| 2010 | 0 | — | 0 | 26 |
| 2011 | 1 | — | 0 | 18 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 2 | 2 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 5 | 6 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 1 | 13 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 14 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The S-Test Creatine Kinase Reagent is intended for the quantitative determination of Creatine Kinase activity in serum or heparin plasma using the S40 Clinical Analyzer. Measurements of creatine phosphokinase activity are 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/K082226 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082226: S40 Creatine Kinase (CK).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082226
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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