MODIFICATION TO ALPHA DX SYSTEM

K013118 · First Medical, Inc. · JHX · Oct 15, 2001 · Clinical Chemistry

Device Facts

• Record ID: K013118
• Device Name: MODIFICATION TO ALPHA DX SYSTEM
• Applicant: First Medical, Inc.
• Product Code: JHX · Clinical Chemistry
• Decision Date: Oct 15, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended 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.

Device Story

Alpha Dx System is a fluorescence immunoassay analyzer designed for rapid, point-of-care or clinical laboratory measurement of cardiac markers: myoglobin, CK, CK-MB, and Tnl. The system utilizes Alpha Dx Panel Test Kits as input samples. The analyzer performs fluorescence-based detection to quantify these specific cardiac analytes. Results are provided to healthcare professionals to assist in the assessment of cardiac status. The device facilitates rapid diagnostic decision-making, potentially improving patient management in acute cardiac scenarios.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on 510(k) regulatory review.

Technological Characteristics

Fluorescence immunoassay analyzer; utilizes specific test kits for myoglobin, CK, CK-MB, and Tnl measurement. Class II device under 21 CFR 862.1215, 862.1215, 866.5680; Class I under 21 CFR 862.2560.

Indications for Use

Indicated for the rapid measurement of myoglobin, CK, CK-MB, and Tnl in clinical settings using the Alpha Dx Analyzer and associated test kits. Intended for prescription use.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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.

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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 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)

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Division of Clinical Laboratory Devices

| 510(k) Number | K013118 |
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| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use<br>(Optional Format 1-2-96) |
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