(27 days)
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No
The summary describes a fluorescence immunoassay analyzer and test kits, with no mention of AI, ML, or related concepts like image processing or algorithms that would typically indicate AI/ML functionality.
No
The device is an analyzer used to measure specific substances in the body (myoglobin, CK, CK-MB, and Tnl), which aids in diagnosis rather than directly treating a condition.
Yes
The device is described as an "Immunoassay Analyzer" used for the "rapid measurement of myoglobin, CK, CK-MB, and Tnl," which are biomarkers used in medical diagnosis.
No
The device description explicitly states it is a "fluorescence Immunoassay Analyzer," which is a hardware device, not software only.
Yes, this device 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.
- Device Description: The device is a "fluorescence Immunoassay Analyzer for use with the Alpha Dx Panel Test Kits." Immunoassays are a common method used in IVD testing to detect and quantify specific substances in biological samples.
- Context: The name "Cardiac Panel Test Kit" strongly suggests that the test is performed on biological samples to provide information about a patient's cardiac health.
Therefore, based on the provided information, the Alpha Dx Cardiac Panel Test Kit and its associated analyzer are clearly intended for in vitro diagnostic use.
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 is a fluorescence Immunoassay Analyzer for use with the Alpha Dx Panel Test Kits for the rapid measurement of myoglobin, CK, CK-MB, and Tnl.
Product codes
JHX, MMI, DDR, KHO
Device Description
The Alpha Dx Cardiac Panel Test Kit is intended for use with the Alpha Dx Analyzer. The analyzer is a fluorescence Immunoassay Analyzer for use with the Alpha Dx Panel Test Kits for the rapid measurement of myoglobin, CK, CK-MB, and Tnl.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized eagle with three overlapping wing shapes, symbolizing service to the nation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
First Medical, Inc. c/o Mr. Greg Holland Regulatory Consultant Regulatory Specialists 3722 Sausalito Avenue Irvine, CA 92606
K013118 Re: Trade/Device Name: Alpha Dx System Regulation Number: 21 CFR 862.1215; 21 CFR 862.1215; 21 CFR 866.5680; 21 CFR.862.2560 Regulation Name: Fluorometric method, CPK or Isoenzymes; Immunoassay, Troponin subunit; Myglobin, Antigen, Antisera, Control; Fluorometer for clinical use Regulatory Class: Class II; Class II; Class II; Class I Product Code: JHX; MMI; DDR; KHO Dated: September 11, 2001 Received: September 18, 2001
OCT 1 5 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 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/cdrh/dsma/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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Special 510(k): Device Modification - First Medical Inc.
Page 1
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 Dx Analyzer. The analyzer is a fluorescence Immunoassay Analyzer for use with the Alpha Dx Panel Test Kits for the rapid measurement of myoglobin, CK, CK-MB, and Tnl.
(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 | K013118 |
|---|---|
| --------------- | --------- |
| Prescription Use
(Per 21 CFR 801.109) | OR | Over-The-Counter Use
(Optional Format 1-2-96) |
| ------------------------------------------ | ---- | -------------------------------------------------- |
|---|