510(k) · Cleared
ClearedELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elitechgroup · CIG Diazo Colorimetry, Bilirubin
Cleared on Jul 11, 2017 as substantially equivalent to K060325 (Horiba Abx, 2006) after a 60-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Jul 11, 2017
- Review
- 60 days
- Class
- Class II
- Product code
- CIG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K910593 (1991). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK910593 Roche Reagent for Direct BilirubinRoche Diagnostic Systems, Inc. · 1991
- 1 generation backK060325 Abx Pentra Bilirubin, Direct CP, Abx Pentra Bilirubin, Total CP, Abx…Horiba Abx · 2006
- This deviceK171401 ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical…Elitechgroup · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K910593 | Roche Reagent for Direct Bilirubin | Roche Diagnostic Systems, Inc. | 1991 | — |
| −1 | K060325 | Abx Pentra Bilirubin, Direct CP, Abx Pentra Bilirubin, Total CP, Abx Pentra… | Horiba Abx | 2006 | — |
| 0 (this device) | K171401 | ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems… | Elitechgroup | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 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 CIG? 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 CIG device
- #1 K251998 Atellica CH Diazo Total Bilirubin (D_TBil)score 11.8 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K060325 | Abx Pentra Bilirubin, Direct CP, Abx Pentra Bilirubin, Total CP, Abx Pentra Multical…Summary page 4…try, Bilirubin Clinical Chemistry 21 CFR 862.1110 5. Predicate Device: K060325 ABX Pentra Bilirubin, Total CP ABX Pentra Bilirub… | 2006 |
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?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 15.3 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K060325.
How does its category compare?
All CIG devicesCIG Diazo Colorimetry, Bilirubin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · CIG
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · CIG
64in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CIG
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CIG
52in 2025
MAUDE reports naming product code CIG, 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 | 1 | — | 0 | 2 |
| 2008 | 3 | 199 | 0 | 8 |
| 2009 | 2 | — | 3 | 3 |
| 2010 | 1 | — | 0 | 6 |
| 2011 | 2 | — | 0 | 38 |
| 2012 | 0 | — | 0 | 14 |
| 2013 | 5 | 64 | 3 | 8 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 7 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 11 |
| 2018 | 0 | — | 0 | 23 |
| 2019 | 1 | — | 1 | 25 |
| 2020 | 0 | — | 0 | 31 |
| 2021 | 0 | — | 0 | 22 |
| 2022 | 1 | — | 0 | 26 |
| 2023 | 2 | — | 0 | 34 |
| 2024 | 0 | — | 0 | 39 |
| 2025 | 0 | — | 0 | 52 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
ELITech Clinical Systems BILIRUBIN TOTAL 4+1 is intended for the quantitative in vitro diagnostic determination of total bilirubin in human serum and plasma on ELITech Clinical Systems Selectra Pro Series Analyzers. ELITech Clinical Systems BILIRUBIN DIRECT 4+1 is intended for the quantitative in vitro diagnostic determination of direct bilirubin in human serum and plasma on ELITech Clinical Systems Selectra Pro Series Analyzers. It is not intended for…
Read the full statement (116 words)
ELITech Clinical Systems BILIRUBIN TOTAL 4+1 is intended for the quantitative in vitro diagnostic determination of total bilirubin in human serum and plasma on ELITech Clinical Systems Selectra Pro Series Analyzers.
ELITech Clinical Systems BILIRUBIN DIRECT 4+1 is intended for the quantitative in vitro diagnostic determination of direct bilirubin in human serum and plasma on ELITech Clinical Systems Selectra Pro Series Analyzers.
It is not intended for use in Point of Care settings.
Measurements of the levels of bilirubin (direct or total), an organic compound formed during the normal and abnormal distruction of red blood cells, are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K171401 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171401: ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171401
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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