510(k) · Cleared
ClearedCalcium-Cresolphthalein, Glucose, Urea/Bun-UV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosystems S.A. · CHW Titrimetric With Edta And Indicator, Calcium
Cleared on Sep 9, 2020 after a 348-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Sep 9, 2020
- Review
- 348 days
- Class
- Class II
- Product code
- CHW
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CHW? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All CHW devicesCHW Titrimetric With Edta And Indicator, Calcium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · CHW
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · CHW
Too few CHW 510(k)s in any year since 2007 to give a median.
Recalls per year · CHW
No recall names CHW since 2007.
Adverse event reports per year · CHW
22in 2025
MAUDE reports naming product code CHW, 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 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 7 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 23 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
CALCIUM-CRESOLPHTHALEIN: Reagent for the measurement of calcium concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory. GLUCOSE: Reagent for the measurement…
Read the full statement (165 words)
CALCIUM-CRESOLPHTHALEIN: Reagent for the measurement of calcium concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.
GLUCOSE: Reagent for the measurement of glucose concentration in human serum and plasma. The obtained values are useful as an aid in the diagnosis and treatment of the diabetes mellitus. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.
UREA/BUN - UV: Reagent for the measurement of urea concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis of certain renal and metabolic diseases. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K192730 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192730: Calcium-Cresolphthalein, Glucose, Urea/Bun-UV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192730
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026