LogoFDA 510(k) Search
K Number
K980574
Device Name
AURAFLEX TSH-3 200 TEST PACK MODEL NUMBER 80600, AURAFLEX TSH-3 CALIBRATOR PACK MODEL NUMBER NUMBER 80601 AURAFLEX DIL0
Manufacturer
ALFA BIOTECH (UK) LTD.
Date Cleared
1998-03-24

(35 days)

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

AuraFlex TSH-3 is a "third generation" fluorescent enzyme immunoassay for the quantitative determination of thyroid stimulating hormone (TSH) in human serum or plasma using the AuraFlex system.

Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

Device Description

AuraFlex TSH-3 is a "third generation" fluorescent enzyme immunoassay for the quantitative determination of thyroid stimulating hormone (TSH) in human serum or plasma using the AuraFlex system.

AI/ML Overview

This document is an FDA 510(k) clearance letter for the AuraFlex® TSH-3 device, which is a fluorescent enzyme immunoassay for the quantitative determination of thyroid stimulating hormone (TSH). The letter indicates that the device has been found substantially equivalent to predicate devices. However, the provided text does not contain the acceptance criteria, details of a study that proves the device meets those criteria, or any of the specific information requested in points 1-9 of your prompt.

The document primarily focuses on:

  • The FDA's decision of substantial equivalence (K980574).
  • Regulatory classifications (Class II, Product Codes JLW, JIS).
  • Applicable general and special controls provisions of the Federal Food, Drug, and Cosmetic Act.
  • Instructions for the manufacturer regarding CLIA complexity, labeling, promotion, and other responsibilities.
  • The intended use of the device ("third generation" fluorescent enzyme immunoassay for quantitative determination of TSH in human serum or plasma using the AuraFlex system to diagnose thyroid or pituitary disorders).

Therefore, based solely on the provided text, I cannot answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods. This information would typically be detailed in the 510(k) submission itself or a separate study report, which is not part of this letter.

§ 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.