3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM

• K Number: K981312
• Device Name: 3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
• Manufacturer: BAYER CORP.
• Date Cleared: 1998-06-05 ( 56 days)
• Product Code: JLW , JIS , JJX
• Regulation Number: 862.1690
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

This in vitro diagnostic method is intended to quantitatively measure thyroid stimulating hormone in human serum or plasma on the Bayer Immuno 1 System. Measurements of TSH, with a 3td Generation sensitivity of

Device Description

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AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:

Device: 3rd Generation TSH Method for the Bayer Immuno 1™ System

Intended Use: To quantitatively measure thyroid stimulating hormone (TSH) in human serum or plasma with 3rd generation sensitivity on the Bayer Immuno 1 System, for use in the diagnosis of thyroid or pituitary disorders.

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1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the performance benchmarks set against legally marketed predicate devices (Bayer Immuno 1 TSH Assay, (Chiron) Ciba-Corning ACS™ TSH-3 Assay, and (Roche) Boehringer-Mannheim Elecsys® TSH Assay). The specific acceptance criterion for sensitivity is explicitly stated in the "Indications For Use" as `

Regulation Number and Section

§ 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.