(274 days)
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No
The summary describes a test strip for quantitative screening of ketones, which is a chemical assay and does not mention any computational or algorithmic processing indicative of AI/ML.
No
The device is an in vitro diagnostic (IVD) quantitative screening tool for ketones, used for diagnostic purposes rather than for treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section states that the device is "intended for the in vitro diagnostic quantitative screening for Ketones".
No
The device is described as a "Test Strip," which is a physical component used for in vitro diagnostic testing. This indicates it is a hardware device, not software-only.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" explicitly states that the device is "intended for the in vitro diagnostic quantitative screening for Ketones in whole blood, serum and plasma". The term "in vitro diagnostic" is a direct indicator.
- Sample Type: The device analyzes "whole blood, serum and plasma," which are biological samples typically used in in vitro diagnostic testing.
- Purpose: The purpose is to "screen for ketosis and Diabetic Ketoacidosis," which are medical conditions diagnosed through laboratory testing.
The definition of an IVD is a medical device that is used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening. This device clearly fits that description.
N/A
Intended Use / Indications for Use
The MTM Bio Scamer K Test Strip is intended for the in vitro digginatic quantitative screenin a for Ketones in whole blood, servin and plasme in physicians' office laboratories and at bedside in aeute and convalescent care facilities to screen for ketosis and Diabetic Ketoandesis
Product codes
JMK
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
physicians' office laboratories and at bedside in aeute and convalescent care facilities
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): 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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 862.1380 Hydroxybutyric dehydrogenase test system.
(a)
Identification. A hydroxybutyric dehydrogenase test system is a device intended to measure the activity of the enzyme alpha-hydroxybutric dehydrogenase (HBD) in plasma or serum. HBD measurements are used in the diagnosis and treatment of myocardial infarction, renal damage (such as rejection of transplants), certain hematological diseases (such as acute leukemias and megaloblastic anemias) and, to a lesser degree, liver disease.(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 the limitations in § 862.9.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design.
FEB 26 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Margo Enright Polymer Technology Systems, Inc. 7736 Zionsville Road Indianapolis, Indiana 46268
Re: K981865
Trade Name: MTM BioScanner K Test Strips Regulatory Class: I Product Code: JMK Dated: January 4, 1999 Received: January 6, 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 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 Gutman
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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510(k) Number (if known): Device Name: MTm Bio Scanner K Test Strips Indications For Use:
The MTM Bio Scamer K Test Strip is intended for the in vitro digginatic quantitative screenin a for Ketones in whole blood, servin and plasme in physicians' office laboratories and at bedside in aeute and convalescent care facilities to screen for ketosis and Diabetic Ketoandesis
Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K981865
(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)
OR
Over-The-Counter Use
(Optional Format 1-2-96)