(206 days)
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No
The summary describes a standard immunoturbidimetric assay for quantifying a specific protein, with no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is an in vitro diagnostic test kit used for quantification of alpha-1-antitrypsin to aid in diagnosis, not to treat a condition.
Yes
The device is described as aiding in the "diagnosis of several conditions" and "alpha-l-antitrypsin deficiency".
No
The device is described as a "Test Kit" and an "immunoturbidimetric assay," which strongly implies the use of physical reagents and laboratory equipment, not just software. The description focuses on the biological measurement process rather than software functionality.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantification of human alpha-l-antitrypsin in human serum by immunoturbidimetric assay." This involves testing a sample taken from the human body (serum) outside the body (in vitro) to provide diagnostic information.
- Diagnostic Purpose: The intended use also states that the measurement "aids in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver" and that "alpha-l-antitrypsin deficiency has been associated with pulmonary emphysema." This clearly indicates a diagnostic purpose.
- Sample Type: The device uses human serum, which is a biological sample taken from a patient.
- Testing Method: Immunoturbidimetric assay is a common laboratory technique performed in vitro.
All these factors align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The N-Assay TIA Alpha-l-Antitrypsin Test Kit is intended for the quantification of human alpha-l-antitrypsin in human serum by immunoturbidimetric assay. The measurement of of alpha-lantitrypsin aids in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition. alpha-l-antitrypsin deficiency has been associated with pulmonary emphysema.
Product codes
DEM
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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§ 866.5130
Alpha -1-antitrypsin immunological test system.(a)
Identification. Analpha -1-antitrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha -1-antitrypsin (a plasma protein) in serum, other body fluids, and tissues. The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition,alpha -1-antitrypsin deficiency has been associated with pulmonary emphysema.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.
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 : K965100/S2 Trade Name: N-Assay TIA Alpha-1-Antitrypsin Test Kit Regulatory Class: II Product Code: DEM Dated: June 14, 1997 Received: June 17, 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 requlatory 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 for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.
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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 requlation (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 Putman
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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510(k) Number (il known): K965100
Ocvice Name: N-Assay TIA Alpha-l-Antitrypsin Test Kit
Indications I-or Use:
The N-Assay TIA Alpha-l-Antitrypsin Test Kit is intended for the quantification of human alpha-l-antitrypsin in human serum by immunoturbidimetric assay. The measurement of of alpha-lantitrypsin aids in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition. alpha-l-antitrypsin deficiency has been associated with pulmonary emphysema.
Peter E. Merlin
(Division Sign-Off)
Division of Clinical Laboratory Devices 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CORH, Office of Device Evaluation (ODE)