# K151792: Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Nov 20, 2015 after 142 days
- Product code: JLW (Radioimmunoassay, Thyroid-Stimulating Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1690
- Recalls of this device: 22 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K902336 (1990). 6 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041133: Modification to Bayer Advia Centaur Automated Chemiluminescence Analyzer, Bayer Healthcare, LLC (2004) Summary page 4.
- K150403: ADVIA Centaur TSH3-Ultra, Siemens Healthcare Diagnostics, Inc. (2015) Summary page 4.

## Most influential descendants
- K162698: MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer (2017), 1 descendant of its own
- K232587: MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer (2024), 0 descendants of its own
- K222116: Atellica® CI Analyzer,  Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP) (2023), 0 descendants of its own
- K161954: Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc) (2017), 0 descendants of its own

## Recalls of this device
- Apr 13, 2022 · Class II · Z-1252-2022: 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: 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: 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 
- Sep 28, 2021 · Class II · Z-0124-2022: 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 
- May 13, 2021 · Class II · Z-2027-2021: 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. T
- May 13, 2021 · Class II · Z-2028-2021: 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. T
- Dec 2, 2020 · Class II · Z-0862-2021: 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: 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: 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
- Oct 26, 2020 · Class II · Z-0474-2021: 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
- May 7, 2020 · Class II · Z-2404-2020: 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: 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: 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: 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: There were multiple issues identified in the system software which required an update.
- Mar 7, 2019 · Class II · Z-1299-2019: There were multiple issues identified in the system software which required an update.
- Sep 26, 2018 · Class II · Z-0780-2019: 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: 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: 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 
- Jun 29, 2018 · Class II · Z-0192-2019: 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 
- Feb 26, 2018 · Class II · Z-1586-2018: 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: When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers

## Indications for use
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.

Source page: https://510kreport.com/device/K151792
Methodology: https://510kreport.com/methodology