510(k) · Cleared
ClearedTotal Bile Acids Assay, Model DZ042A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diazyme Laboratories · KWW Radioimmunoassay, Cholyglycine, Bile Acids
Cleared on Dec 7, 2005 as substantially equivalent to K872296 (Sigma Diagnostics, Inc., 1987) after a 163-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- Dec 7, 2005
- Review
- 163 days
- Class
- Class II
- Product code
- KWW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K872296 (1987). No later device cites it as a predicate yet.
- Root · 1 generation backK872296 Bile Acids ReagentSigma Diagnostics, Inc. · 1987
- This deviceK051714 Total Bile Acids Assay, Model DZ042ADiazyme Laboratories · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K872296 | Bile Acids Reagent | Sigma Diagnostics, Inc. | 1987 | — |
| 0 (this device) | K051714 | Total Bile Acids Assay, Model DZ042A | Diazyme Laboratories | 2005 | — |
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 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? (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 |
|---|---|---|---|
| * | K872296 | Bile Acids ReagentSummary page 1…ycine, Bile acids Device Class: II Predicate Device: The legally marketed device to which we are claiming equivalence [807.92(a)(3)]: Bile Acids Reagent (K872296) manufactured by Trinity Biotech, USA, 1930 Innerbelt Business Center Drive, St. Louis, MO, 63114. Description of the device Th… | 1987 |
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.
How does its category compare?
All KWW devicesKWW Radioimmunoassay, Cholyglycine, Bile Acids: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Total Bile Acids Assay is intended for the in vitro quantitative determination of
total bile acids (TBA) in human serum samples. Total bile acids are metabolized
in the liver and serve as a marker for normal and abnormal liver function. Serum
total bile acids are increased in patients with liver disease.
Total Bile Acids Assay contains a bile acid calibrator. The calibrator is design to
be used with the assay for the quantitative determination of TBA in serum.
Total Bile Acids Assay has control design to be used with the assay for the
quantitative determination of TBA in serum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051714 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051714: Total Bile Acids Assay, Model DZ042A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051714
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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