(119 days)
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No
The summary describes a test strip and scanner for cholesterol measurement, with no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is an in-vitro diagnostic device used for screening cholesterol levels, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is described as being for "in-vitro-diagnostic quantitation of total Cholesterol" and is intended to "assist the healthcare professional and the consumer in screening for elevated cholesterol as a risk factor in coronary artery disease," which are diagnostic purposes.
No
The device is described as a "Test Strip" and is used with a "BioScanner 1000," indicating it is a hardware-based system for in-vitro diagnostic testing, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is intended for the "in-vitro-diagnostic quantitation of total Cholesterol in whole blood". The term "in-vitro-diagnostic" is the key indicator.
- Sample Type: The device analyzes "whole blood", which is a biological sample taken from the body, a common characteristic of IVDs.
- Purpose: The purpose is to "assist the healthcare professional and the consumer in screening for elevated cholesterol as a risk factor in coronary artery disease," which is a diagnostic purpose.
Therefore, based on the provided information, the MTM BioScanner C Test Strip is clearly an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MTM BioScanner C Test Strip is intended for the in-vitro-diagnostic quantitation of total Cholesterol in whole blood when used with the MTM BioScanner 1000. This system is intended to assist the healthcare professional and the consumer in screening for elevated cholesterol as a risk factor in coronary artery disease.
Product codes
CHH
Device Description
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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
healthcare professional and the consumer
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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§ 862.1175 Cholesterol (total) test system.
(a)
Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
JUN 2 4 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. James M. Connolly President Polymer Technology Systems, Inc. 7736 Zionsville Road Indianapolis, Indiana 46268
K990688 Re:
Trade Name: MTM BioScanner C Test Strips Regulatory Class: I reserved Product Code: CHH Dated: February 22, 1999 Received: February 25, 1999
Dear Mr. Connolly:
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 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). 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 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 action. In addition, FDA may publish further announcements 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.
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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 Toutman
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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Page_of_of_
510(k) Number (if known): K 190688
Device Name:_ MTM BioScanner C Test Strins
Indications For Use:
The MTM BioScanner C Test Strip is intended for the in-vitro-diagnostic quantitation of total Cholesterol in whole blood when used with the MTM BioScanner 1000. This system is intended to assist the healthcare professional and the consumer in screening for elevated cholesterol as a risk factor in coronary artery disease.
Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices 79 0688 ﻟﻠ 510(k) Number _
:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use √
(Optional Format 1-2-96)