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K Number
K990993
Device Name
BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003
Manufacturer
BIOCHECK, INC.
Date Cleared
1999-06-22

(90 days)

Product Code
JLW
Regulation Number
862.1690
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The BioCheck S-TSH EIA is intended for the quantitative determination of thyrotropin, of thyroid stimulating hormone (TSH) in human serum. The assay is useful in the diagnosis of thyroid or pituitary disorders.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) summary for the Biocheck Sensitive Thyroid Stimulating Hormone (S-TSH) Enzyme Immunoassay Test Kit. It details the regulatory clearance for the device but does not contain the acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than presenting performance data against predefined acceptance criteria for a new study.

§ 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.