N-ASSAY TIA MULTI V-NL by CRESTAT DIAGNOSTICS, INC.

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:

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.
Sample size used for the test set and the data provenance: Not available in the provided text.
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.
Adjudication method: Not available in the provided text.
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.
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.
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.
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.'
How the ground truth for the training set was established: Not applicable/not available.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is left-aligned. The text is black against a white background, providing high contrast and readability.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Crestat Diagnostics, Inc. c/o Ms. Mary Rees Official Correspondent 374 Goodhill Road Weston, Connecticut 06883

JUL 1 4 1997

Re: K964299/53 Trade Name: N-Assay TIA Alpha-1-Acid Glycoprotein Test Kit Requlatory Class: I Product Code: LKL Dated: June 10, 1997 Received: June 13, 1997

Dear Ms. Rees:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act 2------------------------------------------------------------------------c - --ﮧ ﻣﺴﮧ 2 ﺳ ﻧﮯ ﻣ ﻧﮯ ۔ ۔ ﻣﺴﮧ

(Optional Format 1-2-96)

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.

This letter will allow you to begin marketing your device as described ------in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page of

K964299 510(k) Number (il known):

Ocvice Name: N-Assay TIA Alpha 1 Acid Glycoprotein Test Kit

Indications For Use:

(PLEASE OO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

EM
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number __

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use __
(Optional Format 1-2-96)

Regulation Number and Section

§ 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.