510(k) · Cleared
Recalled · Class II · 2025Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · JGS Electrode, Ion Specific, Sodium
Cleared on Dec 11, 2015 as substantially equivalent to K990346 (Bayer Corp., 1999) and 1 other predicate after a 164-day review. Its family tree reaches back 1 generation to 1999. 3 later devices descend from it. It has been recalled 12 times.
- Decided
- Dec 11, 2015
- Review
- 164 days
- Class
- Class II
- Product code
- JGS
- Recalls
- 12
- Predicates
- 2
Its longest line of descent runs back 1 generation to K990346 (1999). 2 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK990346 Bayer Advia 1650 Chemistry SystemBayer Corp. · 1999 · Recalled
- This deviceK151767 Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI)…Siemens Healthcare Diagnostics, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK222438 A-LYTE® Integrated Multisensor (IMT Na K Cl)Siemens Healthcare Diagnostics, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK222116 Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone…Siemens Healthcare Diagnostics, Inc. · 2023 · Recalled
- Descendant · cites it directly · 0 of its ownK161954 Atellica Solution, Atellica A-LYTE Integrated Multisensor…Siemens Healthcare Diagnostics · 2017 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K222438A-LYTE® Integrated Multisensor (IMT Na K Cl)Siemens Healthcare Diagnostics, Inc. · 2023 · cites it directly0descendants
- K222116Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL)…Siemens Healthcare Diagnostics, Inc. · 2023 · cites it directly0descendants
- K161954Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH…Siemens Healthcare Diagnostics · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K990346 | Bayer Advia 1650 Chemistry System | Bayer Corp. | 1999 | 14 |
| 0 (this device) | K151767 | Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT… | Siemens Healthcare Diagnostics, Inc. | 2015 | — |
| +1 | K222438 | A-LYTE® Integrated Multisensor (IMT Na K Cl) | Siemens Healthcare Diagnostics, Inc. | 2023 | — |
| +1 | K222116 | Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra… | Siemens Healthcare Diagnostics, Inc. | 2023 | 1 |
| +1 | K161954 | Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica… | Siemens Healthcare Diagnostics | 2017 | 8 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2023 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K990346 | Bayer Advia 1650 Chemistry SystemSummary page 6…Product Predicate Device number Class Regulation Code Trinidad CH Siemens ADVIA® K990346 I 862.2160 JJE System 1800 Chemistry* ADVIA® Sodium TD-LYTE… | 1999 |
| * | K132664 | Advia Chemistry Albumin BCP Reagent (Albp), Advia Chemistry Albumin BCP CalibratorSummary page 6…ADVIA® Chemistry Standard B + Salt ISE Urine Standard Bridge Trinidad CH ADVIA® Chemistry Albumin BCP Albumin BCP Assay K132664 II 862.1035 CJW Reagent (Alb_P) (ALBP) Trinidad CH ADVIA® Chemistry Albumin BCP Albumin B… | 2013 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 22, 2025 | Class II | Z-2027-2025 | Under Investigation by firm | Contamination of the diluent by sodium hypochlorite (NaOCl) which may impact calibrator, quality control (QC), and patient results for all assays except for sodium, potassium, and chloride. |
| Dec 15, 2023 | Class II | Z-1003-2024 | Under Investigation by firm | Potential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH Immunoglobulin M_2 (IgM_2) reagent. |
| Nov 18, 2021 | Class II | Z-0449-2022 | Software design | (1)Software (SW) versions V1.25.1 and lower may result in TDef (Test Definition) Parameters for Open Channel Assays reverting to Default Value would shift test results by the magnitude of the implemented Assay Correlation factor; (2) On… |
| May 13, 2021 | Class II | Z-2026-2021 | Component design/selection | Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and leaking over time. The leaking is a risk in valves subject… |
| May 4, 2021 | Class II | Z-1870-2021 | Device Design | Photometer Lamp May Reach Saturation Without Flagging Results, may generate erroneously elevated or depressed patient results |
| Dec 2, 2020 | Class II | Z-0861-2021 | Under Investigation by firm | Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results |
| Feb 27, 2020 | Class II | Z-1797-2020 | Under Investigation by firm | Editing an assay Test Definition and switching to another assay s Test Definition screen without saving the changes using the save button on the screen, may corrupt the settings of the assay s test definition, and Auto-Rerun or… |
| Oct 11, 2019 | Class II | Z-0862-2020 | Under Investigation by firm | On the Atellica CH 930 Analyzer, when scanning barcodes at the module console for Integrated Multisensor Technology (IMT) system fluids (Standard A (Std A) and Standard B (Std B)) for Sodium (Na), Potassium (K), and Chloride (Cl), the… |
| Sep 23, 2019 | Class II | Z-0581-2020 | Software design | Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher. |
| Jul 30, 2019 | Class II | Z-0148-2020 | Software design | Atellica CH 930 Analyzer - Erroneous Indices for Hemolysis and Lipemia in Software versions 1.19.2 and below |
| Sep 26, 2018 | Class II | Z-0782-2019 | Software design | Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica IM 1300 Analyzer Atellica IM 1600 Analyzer;Atellica CH 930 Analyzer; Atellica Sample Handler Prime |
| Jun 29, 2018 | Class II | Z-0194-2019 | Software design | Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks and Ancillary Packs when more than one (1) lot of specific… |
The 5 latest of 12 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All JGS devicesJGS Electrode, Ion Specific, Sodium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Trinidad CH System is an automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. The system’s chemical and immunochemical assay applications utilize photometric and ion selective electrode technology for clinical use. The TD-LYTE Integrated Multisensor (Na, K, Cl) is intended for in vitro diagnostic use in the quantitative determination of sodium, potassium and chloride (Na, K, Cl) in human serum…
Read the full statement (297 words)
The Trinidad CH System is an automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. The system’s chemical and immunochemical assay applications utilize photometric and ion selective electrode technology for clinical use.
The TD-LYTE Integrated Multisensor (Na, K, Cl) is intended for in vitro diagnostic use in the quantitative determination of sodium, potassium and chloride (Na, K, Cl) in human serum, plasma and urine using the Trinidad CH System. Measurements of sodium obtained by this device 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. Measurements of potassium obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The TD-LYTE IMT Standard A is intended for the calibration of Na, K, and Cl on the Trinidad CH System.
The TD-LYTE IMT Standard B + Salt Bridge is intended for the calibration of Na, K, and Cl on the Trinidad CH System.
The Albumin BCP Reagent (Alb_P) is intended for in vitro diagnostic use in the quantitative measurement of albumin in human serum or plasma on the Trinidad CH System. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.
The Albumin BCP calibrator is for in vitro diagnostic use in the calibration of the Trinidad CH Albumin BCP Assay (AOE_P) on the Trinidad CH System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151767 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151767: Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151767
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