(12 days)
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No
The summary describes a fluorescence immunoassay analyzer and test kits for measuring cardiac markers. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is described as a "fluorescence Immunoassay Analyzer for the rapid measurement of myoglobin, CK, CK-MB, and Tnl," which indicates it is a diagnostic tool, not a therapeutic one.
Yes
The device is explicitly stated to measure biomarkers (myoglobin, CK, CK-MB, and TnI) which are used to diagnose cardiac conditions. This fits the definition of a diagnostic device.
No
The device is described as a "Test Kit" and is intended for use with an "Analyzer," both of which are hardware components. The summary does not mention any software-only functionality.
Yes, based on the provided information, the Alpha Dx Cardiac Panel Test Kit is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the kit is for the "rapid measurement of myoglobin, CK, CK-MB, and Tnl." These are biomarkers measured in biological samples (likely blood or serum) to aid in the diagnosis or assessment of cardiac conditions. This aligns with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Method: The method described is "fluorescence Immunoassay Analyzer," which is a common technique used in in vitro diagnostics to detect and quantify specific substances in biological samples.
The fact that it's a "Test Kit" used with an "Analyzer" further supports its role in performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The Alpha Dx Cardiac Panel Test Kit is intended for use with the Alpha DX Analyzer. The analyzer uses Test Kits for the rapid measurement of myoglobin, CK, CK-MB, and Tnl.
Product codes
MMI, JHX, DDR
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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§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
First Medical, Inc. c/o Mr. Greg Holland Regulatory Consultant 3722 Avenue Sausalito Irvine, CA 92606
Re:
DEC 1 82001
K014024 Trade/Device Name: Alpha DX System Regulation Numbers: 21 CFR 862.1215; 21 CFR 866.5680 Regulation Names: Creatine phosphokinase/creatine kinase or isoenzymes test system; Myoglobin immunological test system Regulatory Class: Class II; Class II; Class II Product Code: MMI; JHX; DDR Dated: December 3, 2001 Received: December 6, 2001
Dear Mr. Holland:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Autman
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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Indications for Use Statement
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Alpha Dx System
Indications For Use:
The Alpha Dx Cardiac Panel Test Kit is intended for use with the Alpha The Alpha DX Gardiao Fansi a fluorescence Immunoassay Analyzer for DX Analyzer. The analy 2011 Test Kits for the rapid measurement of myoglobin, CK, CK-MB, and Tnl.
Howard Rust for Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K014024
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use (Optional Format 1-2-96)
REGULATORY SPECIALISTS, INC.