← Product Code [DDR](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDR) · K981012 # AIA-PACK MYOGLOBIN ASSAY (K981012) _Tosoh Medics, Inc. · DDR · May 28, 1998 · Immunology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDR/K981012 ## Device Facts - **Applicant:** Tosoh Medics, Inc. - **Product Code:** [DDR](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDR.md) - **Decision Date:** May 28, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.5680 - **Device Class:** Class 2 - **Review Panel:** Immunology ## Indications for Use AIA-PACK Myoglobin is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of myoglobin in human serum and plasma on specific TOSOH AIA System analyzers. Measurements obtained by this device aid in the diagnosis and monitoring of cardiac disease. ## Device Story AIA-PACK Myoglobin is an in vitro diagnostic assay used on TOSOH AIA System analyzers. It quantitatively measures myoglobin levels in human serum and plasma samples. The device is intended for use in clinical laboratory settings by trained laboratory personnel. Results are provided to clinicians to assist in the diagnosis and monitoring of cardiac disease, such as myocardial infarction. The assay provides objective data that informs clinical decision-making regarding cardiac patient management. ## Technological Characteristics In vitro diagnostic assay for quantitative measurement of myoglobin; designed for use on TOSOH AIA System analyzers; utilizes serum and plasma samples. ## Regulatory Identification A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease. ## 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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings outstretched, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 MAY 2 8 1998 Lori Robinson Manager, Quality Assurance Tosoh Medics, Inc. 373 D Vintage Park Drive, Suite D Foster City, California 94404 Re : K981012 AIA-PACK Myoglobin Assay Regulatory Class: II Product Code: DDR Dated: March 17, 1998 Received: March 19, 1998 Dear Ms. Robinson: 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 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰੇ 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 In addition, FDA may publish further announcements action. 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. {1}------------------------------------------------ Page 2 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Steven Gutman Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health Enclosure {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for Tosoh Medics, Inc. The logo consists of a stylized four-leaf clover shape with a square in the center, along with the text "TOSOH MEDICS, INC." to the right of the clover. Below the clover is the text "TOSOH", and a horizontal line is placed below the text "TOSOH MEDICS, INC." ## PREMARKET NOTIFICATION ## INDICATION FOR USE STATEMENT ## AIA-PACK Myoglobin Assay AIA-PACK Myoglobin is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of myoglobin in human serum and plasma on specific TOSOH AIA System analyzers. Measurements obtained by this device aid in the diagnosis and monitoring of cardiac disease. (Division Sign-Off) Division of Clinical Laboratory vice 510(k) Number 12981012 Prescription use ✓ --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDR/K981012](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDR/K981012) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com