510(k) · Cleared
ClearedElitech Clinical Systems Bilirubin Total 4+1, Elitech Clinical Systems Elical 2, Elitech Clinical Systmes Elitrol I & II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elitechgroup · CIG Diazo Colorimetry, Bilirubin
Cleared on Oct 7, 2011 as substantially equivalent to K060325 (Horiba Abx, 2006) and 2 other predicates after a 200-day review. Its family tree reaches back 3 generations to 1981.
- Decided
- Oct 7, 2011
- Review
- 200 days
- Class
- Class II
- Product code
- CIG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K811832 (1981). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK811832 Precinorm U & Precipath U Human SerumBoehringer Mannheim Corp. · 1981
- 2 generations backK992900 Precinorm Universal and Precipath Universal Control SeraRoche Diagnostics Corp. · 1999
- 1 generation backK041227 Modification to:Roche Diagnostics Precinorm Universal and Precipath…Roche Diagnostics Corp. · 2004
- This deviceK110780 Elitech Clinical Systems Bilirubin Total 4+1, Elitech Clinical…Elitechgroup · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K811832 | Precinorm U & Precipath U Human Serum | Boehringer Mannheim Corp. | 1981 | — |
| −2 | K992900 | Precinorm Universal and Precipath Universal Control Sera | Roche Diagnostics Corp. | 1999 | — |
| −1 | K041227 | Modification to:Roche Diagnostics Precinorm Universal and Precipath Universal… | Roche Diagnostics Corp. | 2004 | — |
| 0 (this device) | K110780 | Elitech Clinical Systems Bilirubin Total 4+1, Elitech Clinical Systems Elical… | Elitechgroup | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 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? (3)
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…r Direct) test System (Sec.862.1 110) Product code CIG - Diazo, Colorimetry, Bilirubin Predicate device ABX PENTRA BILIRUBIN, DIRECT CP (K060325) Device description The device for this submission isavailable as kit only. It consists of 2… | 2006 |
| * | K033501 | Modification to Calibrator for Automatic Systems (Cfas)Summary page 6…JIX- Calibrator, multi-analyte mixture Predicate device Roche Diagnostics Calibrator for Automated Systems (C.f.a.s) (K033501) Device description ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on… | 2003 |
| * | K041227 | Modification to:Roche Diagnostics Precinorm Universal and Precipath Universal Control SeraSummary page 8…(21 CFR 862.1660) Product code JJY- Multi-analyte controls - all kinds Predicate device Roche Diagnostics Precinorm U (K041227) Roche Diagnostics Precipath U (K041227) Device description ELITech Clinical Systems ELITROL… | 2004 |
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 30 years and passes through 3 companies; a new generation was cleared every 7.4 years on median.
- None of the 8 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. 2011, 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 analyzers. It is not intended for use in Point of Care settings. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis and treatment of liver, hemolytic…
Read the full statement (222 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 analyzers.
It is not intended for use in Point of Care settings.
Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder blockage.
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 analyzers.
It is not intended for use in Point of Care settings.
Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder blockage.
ELiTech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on ELiTech Clinical Systems Selectra analyzers.
ELiTech Clinical Systems ELITROL I & ELITROL 11 are multi-parametric control sera for in vitro diagnostic use in the quality control of quantitative ELITech Clinical Systems methods on ELiTech Clinical Systems Selectra analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110780 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110780: Elitech Clinical Systems Bilirubin Total 4+1, Elitech Clinical Systems Elical 2, Elitech Clinical Systmes Elitrol I & II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110780
Report an extraction error
Are you the manufacturer?
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