(37 days)
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No
The document describes a standard in vitro diagnostic test and reagent cartridge, with no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is described as an "in vitro diagnostic device" used for the quantitative measurement of Thyroid Stimulating Hormone (TSH) and for manual dilution of samples. Its purpose is for diagnosis and monitoring of thyroid disease, not for treating or curing a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurements of TSH are used in the diagnosis and monitoring of thyroid disease." Additionally, the "Device Description" identifies the product as an "in vitro diagnostic device."
No
The device description explicitly states it is an in vitro diagnostic device consisting of prepackaged reagents in a plastic cartridge and a liquid diluent, indicating it is a hardware-based diagnostic kit, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: Explicitly states "The TSHL method is an in vitro diagnostic test..." and "The TSH Sample Diluent is an in vitro diagnostic product...". It also describes the purpose of the test as being for the "quantitative measurement of Thyroid Stimulating Hormone (TSH, thyrotropin) in human serum and plasma" and that these measurements are "used in the diagnosis and monitoring of thyroid disease." This clearly indicates the device is intended for use on biological samples outside of the body for diagnostic purposes.
- Device Description: Describes the "Dimension® TSHL Flex® reagent cartridge is an in vitro diagnostic device...".
The document repeatedly uses the term "in vitro diagnostic" and describes the device's function as analyzing biological samples (serum and plasma) to aid in the diagnosis and monitoring of a disease (thyroid disease). This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TSHL method is an in vitro diagnostic test intended for the quantitative measurement of Thyroid Stimulating Hormone (TSH, thyrotropin) in human serum and plasma on the Dimension® EXLTM with LM system. Measurements of TSH are used in the diagnosis and monitoring of thyroid disease.
The TSH Sample Diluent is an in vitro diagnostic product for manual dilution of samples with elevated TSH results processed on the Dimension Vista® and Dimension® EXL™ with LM Systems.
Product codes (comma separated list FDA assigned to the subject device)
JLW
Device Description
The Dimension® TSHL Flex® reagent cartridge is an in vitro diagnostic device that consists of prepackaged reagents in a plastic eight-well cartridge for use on the Dimension® EXL™ with LM system.
The TSH Sample Diluent is a liquid, bovine serum albumin based product with preservatives.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method comparison studies were conducted on the Dimension® TSHL Flex® vs. the Dimension® Vista TSH Flex® reagent cartridge using two hundred-and-ten (210) serum samples. The data was analyzed using least squares linear regression. The Dimension® TSHL Flex® demonstrated excellent correlation to the predicate device as evidenced by a correlation coefficient = 0.997.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation coefficient = 0.997
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 862.1690 Thyroid stimulating hormone test system.
(a)
Identification. A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.(b)
Classification. Class II.
0
MAY 2 3 2008
510(k) Summary of Safety and Effectiveness Dimension® TSHL Flex® reagent cartridge and TSH Sample Diluent
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: