510(k) · Cleared
Recalled · Class II · 2016Elitech Clinical Systems Selectra Prom/Elical 2/Elitrol I and Elitrol II/Ast/Got 4+1 SL/Potassium, Sodium, Chloride...
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elitechgroup Vital Scientific BV · JGS Electrode, Ion Specific, Sodium
Cleared on Mar 24, 2011 as substantially equivalent to K052007 (Horiba Abx, 2005) and 4 other predicates after a 191-day review. Its family tree reaches back 5 generations to 1979. It has been recalled 4 times.
- Decided
- Mar 24, 2011
- Review
- 191 days
- Class
- Class II
- Product code
- JGS
- Recalls
- 4
- Predicates
- 5
Its longest line of descent runs back 5 generations to K781921 (1979). 24 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK781921 Bilirubin, Dingle Valve DPDBoehringer Mannheim Corp. · 1979
- 4 generations backK981632 Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin ReagentRoche Diagnostics/Boehringer Mannheim GmbH · 1998
- 3 generations backK063543 Cobas Integra Bilirubin Special and Roche/Hitachi Bilrubin Total…Roche Diagnostics Corp. · 2006
- 2 generations backK063744 Cobas Integra C 111Rochdiag · 2007
- 1 generation backK071211 Cobas C 111 AnalyzerRoche Diagnostics · 2007 · Recalled
- This deviceK102647 Elitech Clinical Systems Selectra Prom/Elical 2/Elitrol I and…Elitechgroup Vital Scientific BV · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K781921 | Bilirubin, Dingle Valve DPD | Boehringer Mannheim Corp. | 1979 | — |
| −4 | K981632 | Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin Reagent | Roche Diagnostics/Boehringer Mannheim GmbH | 1998 | — |
| −3 | K063543 | Cobas Integra Bilirubin Special and Roche/Hitachi Bilrubin Total, Models… | Roche Diagnostics Corp. | 2006 | — |
| −2 | K063744 | Cobas Integra C 111 | Rochdiag | 2007 | — |
| −1 | K071211 | Cobas C 111 Analyzer | Roche Diagnostics | 2007 | 3 |
| 0 (this device) | K102647 | Elitech Clinical Systems Selectra Prom/Elical 2/Elitrol I and Elitrol… | Elitechgroup Vital Scientific BV | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1981 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 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 JGS? 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 JGS device
- #1 K252475 ABL90 FLEX PLUS Systemscore 12.2 · 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? (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 |
|---|---|---|---|
| * | K052007 | Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module)Summary page 2…2 === Predicate device: Predicate Instrument or reagent 510(k) Number Product code~s HORIBA ABX PENTRA 400 K052007 JJE JIX (also CEM CGZ JGS) ROCHE cobas clii1 K07121 1 JGS CEM CGZ CI… | 2005 |
| * | K071211 | Cobas C 111 AnalyzerSummary page 2…roduct code~s HORIBA ABX PENTRA 400 K052007 JJE JIX (also CEM CGZ JGS) ROCHE cobas clii1 K07121 1 JGS CEM CGZ CIT CFR JJE DCN AEX PENTRA AST CP K060318 CIT JIX JJY… | 2007 |
| * | K060318 | Hepatic Enzymes on Abx Pentra 400 Clinical Chemistry AnalyzerSummary page 2…CEM CGZ JGS) ROCHE cobas clii1 K07121 1 JGS CEM CGZ CIT CFR JJE DCN AEX PENTRA AST CP K060318 CIT JIX JJY Roche Diagnostics Precinorn Universal and Precipath Universal K041227… | 2006 |
| * | K041227 | Modification to:Roche Diagnostics Precinorm Universal and Precipath Universal Control SeraSummary page 2…AEX PENTRA AST CP K060318 CIT JIX JJY Roche Diagnostics Precinorn Universal and Precipath Universal K041227 JJY Control Sera Roche Diagnostics Calibrator for K330 Automatic Systems (… | 2004 |
| * | K033501 | Modification to Calibrator for Automatic Systems (Cfas)Summary page 6…code 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 human… | 2003 |
| * | — | ISE Calibration kit Named without a submission number |
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 |
|---|---|---|---|---|
| Jul 12, 2016 | Class III | Z-2764-2019 | Software design | Software malfunction; The action being taken due to the device becoming inoperable due to software lockup. |
| Aug 11, 2014 | Class III | Z-0006-2015 | Process control | Some users of ENVOY 500 AST Reagent Kit, reference 55255, for Envoy 500 systems are observing that Quality Control (QC) fails before the product expiry is reached. |
| Jan 10, 2012 | Class II | Z-0158-2020 | Component design/selection | The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced. |
| Jan 10, 2012 | Class II | Z-0157-2020 | Component design/selection | The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 6 companies; a new generation was cleared every 3.6 years on median.
- 6 of the 24 ancestors have a recall of any class.
- 8 other devices also cite its predicate K052007.
How does its category compare?
All JGS devicesJGS Electrode, Ion Specific, Sodium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · JGS
3in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JGS
347in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JGS
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JGS
64in 2025
MAUDE reports naming product code JGS, 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 | — | 7 | 33 |
| 2008 | 2 | — | 1 | 3 |
| 2009 | 2 | — | 0 | 57 |
| 2010 | 1 | — | 1 | 361 |
| 2011 | 3 | 191 | 1 | 912 |
| 2012 | 1 | — | 2 | 412 |
| 2013 | 2 | — | 5 | 510 |
| 2014 | 1 | — | 0 | 251 |
| 2015 | 1 | — | 1 | 158 |
| 2016 | 4 | 198 | 0 | 84 |
| 2017 | 1 | — | 0 | 292 |
| 2018 | 3 | 180 | 0 | 158 |
| 2019 | 3 | 58 | 5 | 105 |
| 2020 | 2 | — | 1 | 89 |
| 2021 | 0 | — | 1 | 91 |
| 2022 | 1 | — | 0 | 60 |
| 2023 | 3 | 347 | 4 | 98 |
| 2024 | 0 | — | 0 | 96 |
| 2025 | 0 | — | 0 | 64 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The ELITech Clinical system Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been applied to spectrophotometric and electrochemical techniques. The system has two core modules: one consisting of a spectrophotometric system for measurement of analytes using spectrophotometric techniques, such as end point, rate and turbidimetric assays. The…
Read the full statement (411 words)
The ELITech Clinical system Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been applied to spectrophotometric and electrochemical techniques. The system has two core modules: one consisting of a spectrophotometric system for measurement of analytes using spectrophotometric techniques, such as end point, rate and turbidimetric assays. The second module is an electrometer used for measurement of electrolytes.
For in vitro diagnostic use only.
ELiTech Clinical Systems AST/GOT 4+1 SL is a reagent for the quantitative in vitro diagnostic determination of the activity of the enzyme Aspartate Amino Transferase (AST) in human serum and plasma on ELiTech Clinical Systems Selectra ProM analyzer. Aspartate Amino Transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
ISE Sodium Electrode
The sodium electrode for the ELiTech Clinical Systems Selectra ProM is intended for the quantitative determination of sodium in serum and plasma. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion or other diseases involving electrolyte imbalance.
SE Potassium Electrode
The potassium electrode for the ELITech Clinical Systems Selectra ProM is intended for the quantitative determination of potassium in serum and plasma. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
ISE Chloride Electrode
The Chloride electrode for the ELiTech Clinical Systems Selectra ProM is intended for the quantitative determination of chloride in serum and plasma. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
ELITech Clinical Systems ELITROL I & ELITROL 11 are multiparametric control sera for in vitro diagnostic use in accuracy and precision of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra ProM analyzer equipped with ISE module.
ELiTech Clinical Systems ISE Calibrators are used for the calibration of sodium (Na+), potassium (K+), and chloride (Cl-) on ELiTech Clinical Systems Selectra ProM analyzer equipped with ISE module.
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 ELiTech Clinical Systems Selectra ProM analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102647 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102647: Elitech Clinical Systems Selectra Prom/Elical 2/Elitrol I and Elitrol II/Ast/Got 4+1 SL/Potassium, Sodium, Chloride....” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102647
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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