(43 days)
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No
The summary describes a standard immunoturbidimetric assay for quantitative determination of a 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 assay used for quantitative determination of a substance in human serum to aid in the diagnosis of conditions, not to treat them.
Yes
The "Intended Use / Indications for Use" section states, "Measurement of Alpha-1-Antitrypsin aids in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver." and "FOR IN VITRO DIAGNOSTIC USE." This explicitly indicates its role in diagnosis.
No
The device is an in vitro diagnostic (IVD) assay, which is a reagent-based test performed in a laboratory setting. The description clearly indicates it's for the quantitative determination of Alpha-1-Antitrypsin in human serum using an immunoturbidimetric assay, which involves physical reagents and laboratory equipment, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "FOR IN VITRO DIAGNOSTIC USE." This is the key indicator that the device is intended for use in diagnosing conditions by testing samples taken from the human body, outside of the body (in vitro).
N/A
Intended Use / Indications for Use
The K-ASSAY Alpha-1 AT Assay is intended to be used for the quantitative determination of Alpha-1-Antitrypsin in human serum by immunoturbidimetric assay. Measurement of Alpha-1-Antitrypsin aids 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. FOR IN VITRO DIAGNOSTIC USE.
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/1 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 a stylized image of an eagle with three wavy lines representing its wings.
NOV 2 4 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Colin Getty Official Correspondent Kamiya Biomedical Company 910 Industry Drive Seattle, Washington 98188
Re: K993444 Trade Name: K-ASSAY Alpha-1 AT Regulatory Class: II Product Code: DEM Dated: October 6, 1999 Received: October 12, 1999
Dear Mr. Getty:
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 legally marketed predicate 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 requirements, 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 for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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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 Sutman
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
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: K-ASSAY Alpha-1 AT.
Indications for Use:
The K-ASSAY Alpha-1 AT Assay is intended to be used for the quantitative determination of Alpha-1-Antitrypsin in human serum by immunoturbidimetric assay. Measurement of Alpha-1-Antitrypsin aids 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. FOR IN VITRO DIAGNOSTIC USE.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K993444 |
| Prescription Use
| (Per 21 CFR 801.109) | ✓ | OR | Over-The-Counter Use |
|---|---|---|---|
| ------------------------------------------ | --- | ---- | ---------------------- |
Optional Format 1-2-96)