(86 days)
Not Found
Not Found
No
The summary describes an in-vitro diagnostic test strip and analyzer for cholesterol, 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 test strip intended for quantifying cholesterol to assist in screening for elevated cholesterol as a risk factor, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "The MTM BioScanner C Test Strip is intended for the in-vitro diagnostic quantitation of total Cholesterol in human whole blood".
No
The device is an in-vitro diagnostic test strip, which is a physical component used with a separate hardware device (MTM BioScanner 1000). It is not solely software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: The statement explicitly says "intended for the in-vitro diagnostic quantitation of total Cholesterol in human whole blood". The term "in-vitro diagnostic" is the key indicator.
- Device Description: While the description is "Not Found", the intended use clearly defines its function as an in-vitro test.
- Input Imaging Modality: "Not Applicable (in-vitro diagnostic test strip)" further reinforces that it's an IVD.
- Anatomical Site: "Not Applicable (in-vitro diagnostic test strip using whole blood)" also points to it being an IVD, as it's analyzing a sample outside the body.
The core function of analyzing a biological sample (whole blood) outside the body to diagnose or provide information about a medical condition (elevated cholesterol as a risk factor) is the definition of 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 human whole blood when used with the MTM BioScanner 1000. This System is intended to be used to assist the healthcare professional in screening for elevated cholesterol as a risk factor in coronary artery disease.
Product codes
CHH
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professional
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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/2 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a human figure embracing another person.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Jul 22 1998
Margo Enright Polymer Technology Systems, Inc. 7736 Zionsville Road Indianapolis, Indiana
Re : K981493 Trade Name: MTM Bioscanner C Test Strips Model Number BSA 200, BSA 210, BSA 220 Requlatory Class: I Product Code: CHH Dated: June 12, 1998 Received: June 15, 1998
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 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, listinq 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 Requlations.
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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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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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Page _ of/
| 510(k) Number (if known): | K981493 |
|---|---|
| Device Name: | MTM Bioscanner C |
Test Steps## Indications For Use:
The MTM BioScanner C Test Strip is intended for the in-vitro diagnostic quantitation of total Cholesterol in human whole blood when used with the MTM BioScanner 1000. This System is intended to be used to assist the healthcare professional in screening for elevated cholesterol as a risk factor in coronary artery disease.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bivision Sign Off)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K981495
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use_
(Optional Format 1-2-96)