← Product Code [MMI](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MMI) · K014024 # MODIFICATION TO ALPHA DX SYSTEM (K014024) _First Medical, Inc. · MMI · Dec 18, 2001 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MMI/K014024 ## Device Facts - **Applicant:** First Medical, Inc. - **Product Code:** [MMI](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MMI.md) - **Decision Date:** Dec 18, 2001 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 862.1215 - **Device Class:** Class 2 - **Review Panel:** Clinical Chemistry ## 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. ## Device Story Alpha DX System is a fluorescence immunoassay analyzer designed for rapid measurement of cardiac markers: myoglobin, CK, CK-MB, and Tnl. Device utilizes test kits for sample analysis; provides quantitative or qualitative results to clinicians. Used in clinical laboratory settings to assist in cardiac event assessment. System processes biological samples via fluorescence detection; output aids healthcare providers in diagnostic decision-making for patients presenting with potential cardiac symptoms. ## 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 and 866.5680. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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. {1}------------------------------------------------ Page 2 - 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 {2}------------------------------------------------ ## 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. --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MMI/K014024](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MMI/K014024) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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