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510(k) Data Aggregation
K Number
K151792Device Name
Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System
Manufacturer
Siemens Healthcare Diagnostics,Inc.
Date Cleared
2015-11-20
(142 days)
Product Code
JLW, JIT, JJE
Regulation Number
862.1690Why did this record match?
Applicant Name (Manufacturer) :
Siemens Healthcare Diagnostics,Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
Device Description
The Siemens Healthcare Diagnostics Trinidad Immunoassay (IM) system is a floor model, fully automated, microprocessor-controlled, integrated instrument system that utilizes chemiluminescent technology and uses pre-packaged reagent packs to measure a variety of analytes in human body fluids. It is controlled through a combination of custom and off-the-shelf software.
The Trinidad IM TSH assay reagent kit comes in two configurations (100 or 500 test kit) and each kit contains the following:
500 Test Kit:
- 5 ReadyPack primary reagent packs containing Trinidad IM TSH Lite Reagent, Solid Phase, and Ancillary Reagent
- 2 vials of lyophilized Trinidad IM TSH low calibrator
- 2 vials of lyophilized Trinidad IM TSH high calibrator
100 Test Kit:
- 1 ReadyPack primary reagent packs containing Trinidad IM TSH Lite Reagent, Solid Phase, and Ancillary Reagent
- 1 vial of lyophilized Trinidad IM TSH low calibrator
- 1 vial of lyophilized Trinidad IM TSH high calibrator
The ReadyPack consists of the following:
- Lite Reagent 6.0 mL/ reagent pack: The Lite Reagent contains bovine serum albumin (BSA) conjugated to murine monoclonal anti-TSH (~0.3 µg/mL) antibody labeled with acridinium ester, buffer, stabilizers (murine, bovine, caprine proteins), surfactant, and preservatives.
- Solid Phase Reagent 21.0 mL/ reagent pack: The Solid Phase reagent contains anti-fluorescein murine monoclonal antibody covalently linked to paramagnetic particles (~85 µg/mL), buffer, stabilizers (bovine, caprine proteins), surfactant, and preservatives.
- Ancillary Reagent 6.0 mL/ reagent pack: The Ancillary reagent contains FITC conjugated to murine monoclonal anti-TSH antibody (~3 µg/mL), buffer, stabilizers (murine, bovine, caprine proteins), surfactant, and preservatives.
The TSH Calibrator consists of the following:
- After reconstitution, low and high levels of thyroid stimulating hormone (TSH) in HEPES buffered equine serum with sodium azide (< 0.1%) and preservatives. The low and high calibrators are targeted at ~ 0.032 and 97.5 µIU/mL, respectively.
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