(258 days)
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No
The summary describes an immunoturbidimetric assay for quantifying a specific protein in serum, which is a standard laboratory technique and does not mention any AI or ML components.
No
The device aids in diagnosis by quantifying a substance in serum, but it does not directly treat or alleviate a disease or condition.
Yes
The "Intended Use / Indications for Use" section states that the measurement "may aid in the diagnosis of collagen (connective tissue) disorders, tuberculosis, infections, extensive malignancy and diabetes."
No
The device is described as a "Test Kit" and an "immunoturbidimetric assay," which are typically hardware-based laboratory tests involving reagents and equipment, not software alone.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "quantification of human alpha-l-acid glycoprotein in human serum by immunoturbidimetric assay." This involves testing a biological sample (human serum) outside of the body to obtain diagnostic information.
- Diagnostic Purpose: The intended use also states that the measurement "may aid in the diagnosis of collagen ( connective tissue ) disorders, tuberculosis, infections, extensive malignancy and diabetes." This explicitly links the test results to aiding in the diagnosis of various medical conditions.
These are key characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
LKL
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
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
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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
2
Page of
K964299 510(k) Number (il known):
Ocvice Name: N-Assay TIA Alpha 1 Acid Glycoprotein Test Kit
Indications For 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.
(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 __
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