510(k) · Cleared
Recalled · Class II · 2022Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Cleared on Nov 20, 2015 as substantially equivalent to K041133 (Bayer Healthcare, LLC, 2004) and 1 other predicate after a 142-day review. Its family tree reaches back 4 generations to 1990. 4 later devices descend from it. It has been recalled 22 times.
- Decided
- Nov 20, 2015
- Review
- 142 days
- Class
- Class II
- Product code
- JLW
- Recalls
- 22
- Predicates
- 2
Its longest line of descent runs back 4 generations to K902336 (1990). 6 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK902336 Ciba Corning Acs:180 Automated ChemiluminescenceCiba Corning Diagnostics Corp. · 1990
- 3 generations backK971418 Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur…Chiron Diagnostics Corp. · 1997 · Recalled
- 2 generations backK032525 Bayer Advia Centaur Automated Chemiluminescence AnalyzerBayer Healthcare, LLC · 2003
- 1 generation backK041133 Modification to Bayer Advia Centaur Automated Chemiluminescence…Bayer Healthcare, LLC · 2004 · Recalled
- This deviceK151792 Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH…Siemens Healthcare Diagnostics, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK162698 MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay AnalyzerShenzhen New Industries Biomedical Engineering Co., Ltd. · 2017
- Descendant · 2 generations on · 0 of its ownK232587 MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence…Shenzhen New Industries Biomedical Engineering Co., Ltd. · 2024
- 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 4 of 4 · See all- K162698MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay AnalyzerShenzhen New Industries Biomedical Engineering Co., Ltd. · 2017 · cites it directly1descendant
- K232587MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzerShenzhen New Industries Biomedical Engineering Co., Ltd. · 2024 · 2 generations on0descendants
- 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 |
|---|---|---|---|---|---|
| −4 | K902336 | Ciba Corning Acs:180 Automated Chemiluminescence | Ciba Corning Diagnostics Corp. | 1990 | — |
| −3 | K971418 | Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur Analyzer | Chiron Diagnostics Corp. | 1997 | 4 |
| −2 | K032525 | Bayer Advia Centaur Automated Chemiluminescence Analyzer | Bayer Healthcare, LLC | 2003 | — |
| −1 | K041133 | Modification to Bayer Advia Centaur Automated Chemiluminescence Analyzer | Bayer Healthcare, LLC | 2004 | 8 |
| 0 (this device) | K151792 | Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH… | Siemens Healthcare Diagnostics, Inc. | 2015 | — |
| +1 | K162698 | MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2017 | — |
| +2 | K232587 | MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay… | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2024 | — |
| +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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 JLW? 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 JLW device
- #1 K251543 Atellica® IM TSH3-Ultra II (TSH3ULII)score 11.4 · 3 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 |
|---|---|---|---|
| * | K041133 | Modification to Bayer Advia Centaur Automated Chemiluminescence AnalyzerSummary page 4…ssification: Class II 3. Product Code: JIT – Calibrator, Secondary 4. Panel: Clinical Chemistry F. Predicate Devices: ADVIA® Centaur XP system cleared under 510(k) k041133. ADVIA® Centaur Thyroid Stimulating Hormone (TSH3 Ultra) Assay and Calibrators cleared under k150403. Siemens Healthcare Diagnos… | 2004 |
| * | K150403 | ADVIA Centaur TSH3-UltraSummary page 4…. Predicate Devices: ADVIA® Centaur XP system cleared under 510(k) k041133. ADVIA® Centaur Thyroid Stimulating Hormone (TSH3 Ultra) Assay and Calibrators cleared under k150403. Siemens Healthcare Diagnostics 1 Trinidad IM System and Trinidad IM TSH Premarket Notification 510(k) November 201… | 2015 |
What descends from it? (4)
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 |
|---|---|---|---|---|
| Apr 13, 2022 | Class II | Z-1252-2022 | Under Investigation by firm | Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results |
| Apr 13, 2022 | Class II | Z-1253-2022 | Under Investigation by firm | Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results |
| Sep 28, 2021 | Class II | Z-0125-2022 | Under Investigation by firm | Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea level. As a result, customers at these altitudes… |
| Sep 28, 2021 | Class II | Z-0124-2022 | Under Investigation by firm | Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea level. As a result, customers at these altitudes… |
| May 13, 2021 | Class II | Z-2027-2021 | 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 13, 2021 | Class II | Z-2028-2021 | 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… |
| Dec 2, 2020 | Class II | Z-0862-2021 | Under Investigation by firm | Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results |
| Dec 2, 2020 | Class II | Z-0863-2021 | Under Investigation by firm | Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results |
| Oct 26, 2020 | Class II | Z-0473-2021 | Under Investigation by firm | Test Definition scanning may reset custom settings to defaults causing falsely low or high results. When a 2D Master Curve and TDef barcode for a new kit lot of reagent is scanned and the TDef version is a newer version than the version… |
| Oct 26, 2020 | Class II | Z-0474-2021 | Under Investigation by firm | Test Definition scanning may reset custom settings to defaults. When a 2D Master Curve and TDef barcode for a new kit lot of reagent is scanned and the TDef version is a newer version than the version that is currently on the system, some… |
| May 7, 2020 | Class II | Z-2404-2020 | Employee error | Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and IM1600 analyzers. |
| May 7, 2020 | Class II | Z-2405-2020 | Employee error | Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and Atellica IM1600 analyzers. |
| Aug 15, 2019 | Class II | Z-0205-2020 | Under Investigation by firm | Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2 |
| Aug 15, 2019 | Class II | Z-0204-2020 | Under Investigation by firm | Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2 |
| Mar 7, 2019 | Class II | Z-1300-2019 | Under Investigation by firm | There were multiple issues identified in the system software which required an update. |
| Mar 7, 2019 | Class II | Z-1299-2019 | Under Investigation by firm | There were multiple issues identified in the system software which required an update. |
| Sep 26, 2018 | Class II | Z-0780-2019 | 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 |
| Sep 26, 2018 | Class II | Z-0781-2019 | 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-0193-2019 | 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… |
| Jun 29, 2018 | Class II | Z-0192-2019 | 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… |
| Feb 26, 2018 | Class II | Z-1586-2018 | Software design | When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers |
| Feb 26, 2018 | Class II | Z-1588-2018 | Software design | When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers |
The 5 latest of 22 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 7.1 years on median.
- 4 of the 6 ancestors have a recall of any class.
- Of its descendants, K162698 (Shenzhen New Industries Biomedical Engineering Co., Ltd., 2017) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K041133.
How does its category compare?
All JLW devicesJLW Radioimmunoassay, Thyroid-Stimulating Hormone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · JLW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JLW
194in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JLW
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JLW
103in 2025
MAUDE reports naming product code JLW, 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 | 19 |
| 2008 | 5 | 143 | 0 | 10 |
| 2009 | 2 | — | 0 | 41 |
| 2010 | 1 | — | 1 | 34 |
| 2011 | 0 | — | 1 | 167 |
| 2012 | 1 | — | 3 | 144 |
| 2013 | 1 | — | 0 | 168 |
| 2014 | 1 | — | 0 | 155 |
| 2015 | 3 | 142 | 0 | 203 |
| 2016 | 3 | 238 | 1 | 183 |
| 2017 | 4 | 194 | 0 | 235 |
| 2018 | 0 | — | 4 | 249 |
| 2019 | 1 | — | 1 | 216 |
| 2020 | 0 | — | 2 | 145 |
| 2021 | 0 | — | 0 | 146 |
| 2022 | 1 | — | 0 | 137 |
| 2023 | 1 | — | 0 | 162 |
| 2024 | 2 | — | 2 | 169 |
| 2025 | 1 | — | 2 | 103 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Trinidad Immunoassay (IM) system is an automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. The Trinidad IM system’s assay applications utilize chemiluminescent technology for clinical use. The Trinidad IM Thyroid Stimulating Hormone (TSH) assay is for in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in human serum and plasma (EDTA and lithium…
Read the full statement (108 words)
The Trinidad Immunoassay (IM) system is an automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. The Trinidad IM system’s assay applications utilize chemiluminescent technology for clinical use.
The Trinidad IM Thyroid Stimulating Hormone (TSH) assay is for in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in human serum and plasma (EDTA and lithium heparin) using the Trinidad IM system. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
The Trinidad IM TSH Calibrators are for in vitro diagnostic use in calibrating the Trinidad IM system TSH assay.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K151792 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151792: Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151792
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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