510(k) · Cleared
ClearedElitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL Reagents
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seppim S.A.S. · CEO Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Cleared on May 6, 2011 as substantially equivalent to K033501 (Roche Diagnostics Corp., 2003) and 5 other predicates after a 463-day review. Its family tree reaches back 5 generations to 1984.
- Decided
- May 6, 2011
- Review
- 463 days
- Class
- Class I
- Product code
- CEO
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 5 generations to K842280 (1984). 32 ancestors in all, the oldest K801242 (1980). No later device cites it as a predicate yet.
- Root · 5 generations backK842280 TDX DigitoxinAbbott Laboratories · 1984
- 4 generations backK972250 Roche Cobas Integra Reagent Cassettes & Ancillary ReagentsRoche Diagnostic Systems, Inc. · 1997 · Recalled
- 3 generations backK980996 Cobas Integra Carbon Dioxide (CO2-S), Cobas Integra Glucose HK…Roche Diagnostic Systems, Inc. · 1998
- 2 generations backK031879 Cobas Integra Carbon Dioxide AssayRoche Diagnostics Corp. · 2003
- 1 generation backK060205 General Chemistries on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx · 2006 · Recalled
- This deviceK100263 Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV…Seppim S.A.S. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K842280 | TDX Digitoxin | Abbott Laboratories | 1984 | — |
| −4 | K972250 | Roche Cobas Integra Reagent Cassettes & Ancillary Reagents | Roche Diagnostic Systems, Inc. | 1997 | 1 |
| −3 | K980996 | Cobas Integra Carbon Dioxide (CO2-S), Cobas Integra Glucose HK Liquid (Glulf) | Roche Diagnostic Systems, Inc. | 1998 | — |
| −2 | K031879 | Cobas Integra Carbon Dioxide Assay | Roche Diagnostics Corp. | 2003 | — |
| −1 | K060205 | General Chemistries on Abx Pentra 400 Clinical Chemistry Analyzer | Horiba Abx | 2006 | 2 |
| 0 (this device) | K100263 | Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL Reagents | Seppim S.A.S. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 4 | 0 |
| 1999 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 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 CEO? 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? (6)
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 |
|---|---|---|---|
| * | K033501 | Modification to Calibrator for Automatic Systems (Cfas)Summary page 1…JIX- Calibrator, multi-analyte mixture Predicate device Roche Diagnostics Calibrator for Automated Systems (C.t~a.s) (K033501) Device description ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on human… | 2003 |
| * | K060205 | General Chemistries on Abx Pentra 400 Clinical Chemistry AnalyzerSummary page 3…Urea nitrogen test system (Sec.862.1770) Product code COO - Urease And Glutamic Dehydrogenase, Urea Nitrogen Predicate device ABX PENTRA UREA CP (K060205, K070146) Device description The device for this submission is available as kit only. It consists of 2 reagents:… | 2006 |
| * | K070146 | Abx Pentra Glucose HK CP, Urea CP, Uric Acid CPSummary page 3…ogen test system (Sec.862.1770) Product code COO - Urease And Glutamic Dehydrogenase, Urea Nitrogen Predicate device ABX PENTRA UREA CP (K060205, K070146) Device description The device for this submission is available as kit only. It consists of 2 reagents:… | 2007 |
| * | K070249 | Abx Pentra 400, Calcium CP, Creatinine CP, Phosphorus CP, Amylase CP, Urine Control L/HSummary page 7…tem (Sec.862.1 580) Product code CEO - Phosphomolybdate (colorimetric), inorganic phosphorus Predicate device ABX PENTRA PHOSPHORUS CP (K060205, K070249) Device description The device for this submission is available as kit only. It consists of 1 reagent R.… | 2007 |
| * | K081276 | Abx Pentra Glucose HK CP, Abx Pentra Uric Acid CP, Abx Pentra Urine Control L/HSummary page 10…Uric acid test system (Sec.862.1775) Product code KNK - Acid; Uric, Uricase (colorimetric) Predicate device ABX PENTRA Uric acid CP (K060205, K08 1276) Device description The device for this submission isavailable as kit only. It consists of 1reagent R.… | 2008 |
| * | K041227 | Modification to:Roche Diagnostics Precinorm Universal and Precipath Universal Control SeraSummary page 14…and unassayed). (21 CFR 862.1660) Product code JJX- Multi-analyte controls - all kinds Predicate device Roche Diagnostics Precinorm U (K041227) Roche Diagnostics Precipath U(K041 227) 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 27 years and passes through 5 companies; a new generation was cleared every 4.8 years on median.
- 5 of the 32 ancestors have a recall of any class.
- 16 other devices also cite its predicate K033501.
How does its category compare?
All CEO devicesCEO Phosphomolybdate (Colorimetric), Inorganic Phosphorus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · CEO
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · CEO
Too few CEO 510(k)s in any year since 2007 to give a median.
Recalls per year · CEO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CEO
8in 2025
MAUDE reports naming product code CEO, 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 | 0 | — | 1 | 13 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 41 |
| 2011 | 1 | — | 0 | 19 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 3 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 1 | 8 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
ELiTech Clinical Systems PHOSPHORUS reagent is for the quantitative in vitro diagnostic determination of inorganic phosphorus in human serum and plasma on the Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin 0 imbalance. ELiTech Clinical Systems…
Read the full statement (310 words)
ELiTech Clinical Systems PHOSPHORUS reagent is for the quantitative in vitro diagnostic determination of inorganic phosphorus in human serum and plasma on the Vital Scientific Selectra/Flexor analyzers.
It is not intended for use in Point of Care settings.
Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin 0 imbalance.
ELiTech Clinical Systems URIC ACID MONO SL reagent is for the quantitative in vitro diagnostic determination of uric acid in human serum and plasma on the Vital Scientific Selectra/Flexor analyzers.
It is not intended for use in Point of Care settings.
Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
ELiTech Clinical Systems UREA UV SL reagent is for the quantitative in vitro diagnostic determination of urea nitrogen in human serum and plasma on the Vital Scientific Selectra/Flexor analyzers.
It is not intended for use in Point of Care settings.
Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.
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 the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer.
ELiTech Clinical Systems ELITROL I is a multi-para metric control serum for in vitro diagnostic use in accuracy control of quantitative ELiTech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer.
ELiTech Clinical Systems ELITROL II is a multi-parametric control serum for in vitro diagnostic use in accuracy control of quantitative ELiTech Clinical Systems methods on the Vital Scientific Selectra Junior analyzer and the Vital Scientific Flexor Junior analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100263 · printed Nov 3, 2026
Cite this page
510(k) Report. “K100263: Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL Reagents.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K100263
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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