510(k) · Cleared
Recalled · Class II · 2013Elitech Clinical Systems Calcium Arsenazo; Elitech Clinical Systems Albumin; Elitech Clinical Systems Elical 2; Elitech
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elitechgroup · CIX Bromcresol Green Dye-Binding, Albumin
Cleared on Jun 21, 2011 as substantially equivalent to K921625 (Pointe Scientific, Inc.,, 1992) and 3 other predicates after an 88-day review. Its family tree reaches back 4 generations to 1979. It has been recalled once.
- Decided
- Jun 21, 2011
- Review
- 88 days
- Class
- Class II
- Product code
- CIX
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 4 generations to K781921 (1979). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK781921 Bilirubin, Dingle Valve DPDBoehringer Mannheim Corp. · 1979
- 3 generations backK981632 Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin ReagentRoche Diagnostics/Boehringer Mannheim GmbH · 1998
- 2 generations backK063543 Cobas Integra Bilirubin Special and Roche/Hitachi Bilrubin Total…Roche Diagnostics Corp. · 2006
- 1 generation backK063744 Cobas Integra C 111Rochdiag · 2007
- This deviceK110830 Elitech Clinical Systems Calcium Arsenazo; Elitech Clinical Systems…Elitechgroup · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K781921 | Bilirubin, Dingle Valve DPD | Boehringer Mannheim Corp. | 1979 | — |
| −3 | K981632 | Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin Reagent | Roche Diagnostics/Boehringer Mannheim GmbH | 1998 | — |
| −2 | K063543 | Cobas Integra Bilirubin Special and Roche/Hitachi Bilrubin Total, Models… | Roche Diagnostics Corp. | 2006 | — |
| −1 | K063744 | Cobas Integra C 111 | Rochdiag | 2007 | — |
| 0 (this device) | K110830 | Elitech Clinical Systems Calcium Arsenazo; Elitech Clinical Systems Albumin… | Elitechgroup | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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 CIX? 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 CIX device
- #1 K251157 Core Metabolicscore 10.9 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K921625 | Calcium-Arsenazo Iii Reagent SetSummary page 1…CJY- Azo Dye, Calcium Predicate device Stanbio Calcium LiquiColoro (Arsenazo I11) (K921625) Device description The device for this submission is available as kit only. It consists of 1… | 1992 |
| * | K063744 | Cobas Integra C 111Summary page 3…c.862.1035) Product code CIX - Bromcresol green dye-binding, Albumin Predicate device Roche Diagnostics Albumin Gen.2 (K063744) Device description The device for this submission is available as kit only. It consists of 1… | 2007 |
| * | K033501 | Modification to Calibrator for Automatic Systems (Cfas)Summary page 6…SEPPIM S.A.S. Zone industrielle 61500 SEES France 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 7…(assayed and unassayed). (21 OFA 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 4, 2013 | Class II | Z-0178-2014 | Device Design | Calcium Arsenazo Reagent, reference CALA-0250, is recalled due to complaint of plasma specimens report high results than serum. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 5 companies; a new generation was cleared every 8.5 years on median.
- 1 of the 11 ancestors has a recall of any class.
How does its category compare?
All CIX devicesCIX Bromcresol Green Dye-Binding, Albumin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · CIX
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · CIX
168in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CIX
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CIX
4in 2025
MAUDE reports naming product code CIX, 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 | 1 |
| 2008 | 1 | — | 1 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 74 |
| 2011 | 3 | 168 | 0 | 8 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 1 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 1 | — | 0 | 2 |
| 2019 | 1 | — | 1 | 0 |
| 2020 | 0 | — | 1 | 1 |
| 2021 | 2 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
ELiTech Clinical Systems CALCIUM ARSENAZO is intended for the quantitative in vitro diagnostic determination of total calcium in human serum and plasma on ELiTech Clinical Systems Selectra analyzers. It is not intended for use in Point of Care settings. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). ELiTech…
Read the full statement (182 words)
ELiTech Clinical Systems CALCIUM ARSENAZO is intended for the quantitative in vitro diagnostic determination of total calcium in human serum and plasma on ELiTech Clinical Systems Selectra analyzers.
It is not intended for use in Point of Care settings.
Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
ELiTech Clinical Systems ALBUMIN is intended for the quantitative in vitro diagnostic determination of albumin in human serum and plasma on ELiTech Clinical Systems Selectra analyzers.
It is not intended for use in Point of Care settings.
Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
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 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/K110830 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110830: Elitech Clinical Systems Calcium Arsenazo; Elitech Clinical Systems Albumin; Elitech Clinical Systems Elical 2; Elitech.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110830
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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