510(k) · Cleared
ClearedCatachem, Inc., Bile Acids Reagents and/or Bile Acids Test Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Catachem, Inc. · KWW Radioimmunoassay, Cholyglycine, Bile Acids
Cleared on Jan 19, 2007 after a 147-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jan 19, 2007
- Review
- 147 days
- Class
- Class II
- Product code
- KWW
- 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 KWW? 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 KWW devicesKWW Radioimmunoassay, Cholyglycine, Bile Acids: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · KWW
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · KWW
Too few KWW 510(k)s in any year since 2007 to give a median.
Recalls per year · KWW
No recall names KWW since 2007.
Adverse event reports per year · KWW
No MAUDE report names KWW since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Catachemn, Inc. Bile Acids assay is an In-Vitro diagnostic enzymatic assay for the
quantitative determination of total bile acids in human serum.
Measurement of bile acids in human serum, and increased reported levels are
representative of specific liver disease.
For In-Vitro diagnostic use only
Bile Acids Calibrator. (For In-Vitro diagnostic use only)
The bile acids assay contains a calibrator designed for the calibration of the Bile Acids
method.
Bile Acids Controls (For In-Vitro diagnostic use only)
The bile acids assay also contains control Level-I and control Level-II. These controls are
designed to monitor the performance of the Bile Acids assay.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K062503 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062503: Catachem, Inc., Bile Acids Reagents and/or Bile Acids Test Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062503
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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