OPTICOAT T3 EIA KIT

• K Number: K981824
• Device Name: OPTICOAT T3 EIA KIT
• Manufacturer: BIOTECX LABORATORIES, INC.
• Date Cleared: 1998-12-22 ( 214 days)
• Product Code: CDP
• Regulation Number: 862.1710
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A

Intended Use

A total triiodothyronine test system is a device intended to measure the hormone triiodothyronine in serum. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.

Device Description

Not Found

AI/ML Overview

This document is an FDA 510(k) clearance letter for the OptiCoat™ T3 EIA Kit, dated December 22, 1998. It primarily addresses the regulatory approval of the device and does not contain detailed information about the acceptance criteria or the specific study that proves the device meets those criteria.

Therefore, I cannot provide the requested information based on the provided text. The document confirms that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its market clearance, but it does not include the performance data of the device itself.

Regulation Number and Section

§ 862.1710 Total triiodothyronine test system.

(a)
Identification. A total triiodothyronine test system is a device intended to measure the hormone triiodothyronine in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.(b)
Classification. Class II. This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.