CHEMWELL, ALSO KNOWN AS PROJECT 2900

• K Number: K013420
• Device Name: CHEMWELL, ALSO KNOWN AS PROJECT 2900
• Manufacturer: AWARENESS TECHNOLOGY, INC.
• Date Cleared: 2002-07-19 ( 277 days)
• Product Code: JLW , CDP , KLT
• Regulation Number: 862.1690
• Type: Abbreviated
• Panel: CH
• Reference & Predicate Devices: N/A

Intended Use

ChemWell will be used by laboratory technologists to obtain blood chemistry information from patient serum samples. The following quantitative UBI ELISA kits are included in this 510(k): thyroid stimulating hormone (TSH), total triiodothyronine (T3) and total thyroxine (T4). The measurement of these hormones is used for the diagnosis of thyroid disorders.

Device Description

ChemWell, also known as project 2900, used for United Biotech. Inc. (UBI) kits.

AI/ML Overview

This is an FDA Premarket Notification (510(k)) decision letter. It states that the device, 'ChemWell, also know as project 2900, used for United Biotech, Inc. (UBI) kits', is substantially equivalent to a predicate device. This letter does not include acceptance criteria or a study proving the device meets acceptance criteria. It mentions the indications for use, but no performance data. Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details.

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.