LogoFDA 510(k) Search
K Number
K964299
Device Name
N-ASSAY TIA MULTI V-NL
Manufacturer
CRESTAT DIAGNOSTICS, INC.
Date Cleared
1997-07-14

(258 days)

Product Code
LKL
Regulation Number
866.5420
Type
Traditional
Panel
IM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The N-Assay TIA Alpha-l-Acid Glycoprotein Test Kit is intended for the quantification of human alpha-l-acid glycoprotein in human serum by immunoturbidimetric assay. Measurement of alpha 1acid glycoprotein may aid in the diagnosis of collagen ( connective tissue ) disorders, tuberculosis, infections, extensive malignancy and diabetes.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device (N-Assay TIA Alpha-1-Acid Glycoprotein Test Kit) and does not provide detailed information on acceptance criteria or the specific study details that would typically be found in a study report or clinical trial summary.

Therefore, most of the requested information cannot be extracted from the provided text.

However, based on the limited information, here's what can be stated:

  1. A table of acceptance criteria and the reported device performance: Not available in the provided text. The document is a regulatory clearance, not a performance report.

  2. Sample size used for the test set and the data provenance: Not available in the provided text.

  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in the provided text.

  4. Adjudication method: Not available in the provided text.

  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not available in the provided text. This type of study is more common for imaging diagnostics, whereas this device is a laboratory test kit.

  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is an "immunoturbidimetric assay" test kit, implying an automated or semi-automated process for quantification. Its performance would be evaluated in a standalone manner, but the details of such a study are not provided.

  7. The type of ground truth used: For an immunoturbidimetric assay, the "ground truth" for a performance study would typically be established against a reference method or another validated laboratory assay, measuring the actual concentration of alpha-1-acid glycoprotein. The document does not specify the method used to establish ground truth in any study.

  8. The sample size for the training set: Not applicable/not available. This device is a diagnostic test kit, not an AI/machine learning algorithm that typically requires a 'training set.'

  9. How the ground truth for the training set was established: Not applicable/not available.

§ 866.5420

Alpha -1-glycoproteins immunological test system.(a)
Identification. Analpha- 1-glycoproteins immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesalpha- 1-glycoproteins (a group of plasma proteins found in thealpha- 1 group when subjected to electrophoresis) in serum and other body fluids. Measurement of specificalpha- 1-glycoproteins may aid in the diagnosis of collagen (connective tissue) disorders, tuberculosis, infections, extensive malignancy, and diabetes.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.