← Product Code [LBR](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LBR) · K990247 # MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470 (K990247) _Polymer Technology Systems, Inc. · LBR · May 28, 1999 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LBR/K990247 ## Device Facts - **Applicant:** Polymer Technology Systems, Inc. - **Product Code:** [LBR](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LBR.md) - **Decision Date:** May 28, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1475 - **Device Class:** Class 1 - **Review Panel:** Clinical Chemistry ## Intended Use The MTM BioScanner HDL Test Strip is intended for the in-vitro-diagnostic quantitation of HDL Cholesterol in whole blood when used with the MTM BioScanner 1000. This system is intended to be used to assist the healthcare professional in screening for decreased levels of HDL Cholesterol as a risk factor in coronary artery disease. ## Device Story The MTM BioScanner HDL Test Strips are used with the MTM BioScanner 1000 system to measure HDL cholesterol levels in whole blood samples. The system is designed for use by healthcare professionals in clinical settings to screen for low HDL cholesterol, which serves as a risk factor for coronary artery disease. The device provides quantitative results to assist clinicians in assessing patient cardiovascular risk profiles. ## Technological Characteristics In-vitro diagnostic test strip for quantitative HDL cholesterol measurement in whole blood; designed for use with the MTM BioScanner 1000 system. ## Regulatory Identification A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. ## Related Devices - [K993377](/device/K993377.md) — MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC) · Polymer Technology Systems, Inc. · Jan 13, 2000 - [K981493](/device/K981493.md) — MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220 · Polymer Technology Systems, Inc. · Jul 22, 1998 - [K990688](/device/K990688.md) — MTM BIOSCANNER C TEST STRIPS · Polymer Technology Systems, Inc. · Jun 24, 1999 - [K984303](/device/K984303.md) — VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT · Ortho-Clinical Diagnostics, Inc. · Jan 28, 1999 - [K980650](/device/K980650.md) — REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL · Helena Laboratories · May 1, 1998 ## Submission Summary (Full Text) {0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines connecting them. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 MAY 2 8 1999 Ms. Margo Enright Polymer Technology Systems, Inc. 7736 Zionsville Road Indianapolis, IN 46268 Re : K990247 Trade Name: MTM BioScanner HDL Test Strips Requlatory Class: I Product Code: LBR Dated: April 07, 1999 Received: April 08, 1999 Dear Ms. Enright: 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 leqally 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). 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. this response to your premarket notification Please note: 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/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 {2}------------------------------------------------ ## Center for Devices and Radiological Health Page 510(k) Number (if known): Device Name: _MTM BioScanner HDL Test Strips_ Indications for Use: The MTM BioScanner HDL Test Strip is intended for the in-vitro-diagnostic quantitation of HDL Cholesterol in whole blood when used with the MTM BioScanner 1000. This system is intended to be used to assist the healthcare professional in screening for decreased levels of HDL Cholesterol as a risk factor in coronary artery disease. ## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurence of CDRH, Office of Device Evaulation (ODE) (Optional Format 3-10-98) (Posted July 1, 1998) : / : " --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LBR/K990247](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LBR/K990247) **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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