(32 days)
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No
The provided 510(k) summary does not contain any mention of AI, ML, image processing, or any other indicators typically associated with AI/ML technology in medical devices. The description focuses on a quantitative prothrombin time (PT) testing system.
No
The device is intended for quantitative prothrombin time (PT) testing, which is a diagnostic function to monitor blood coagulation. It does not provide treatment or therapy.
Yes
The device is intended for quantitative prothrombin time (PT) testing, which is a diagnostic measurement used to assess blood clotting ability.
No
The summary describes a "CoaguChek System" which is explicitly stated to perform quantitative prothrombin time (PT) testing in fresh capillary or venous whole blood. This process inherently requires a physical device (likely a meter and test strips) to interact with the blood sample and perform the measurement. The summary does not mention any software-only components or functions.
Yes, based on the provided information, the CoaguChek System is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "quantitative prothrombin time (PT) testing in fresh capillary or venous whole blood". This involves testing a biological sample (blood) outside of the body to obtain diagnostic information.
- Nature of the Test: Prothrombin time (PT) testing is a standard laboratory test used to assess blood clotting ability, which is a diagnostic measure.
The definition of an IVD generally includes devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The CoaguChek System fits this description perfectly.
N/A
Intended Use / Indications for Use
The CoaguChek System for professional use is intended for quantitative prothrombin time (PT) testing in fresh capillary or venous whole blood by professional health care providers. The CoaguChek System for Patient Self Testing is intended for the quantitative prothrombin time (PT) testing in fresh capillary blood by selected and suitably trained patients or their caregivers on the prescription of the treating physician.
Product codes
JPA
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
Professional health care providers; selected and suitably trained patients or their caregivers on the prescription of the treating physician.
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
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§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
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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 features a stylized eagle with three curved lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN - 9 1998
Mr. Richard Naples Director, Regulatory Affairs Boehringer Mannheim 9115 Haque Road 46250 Indianapolis, Indiana
RE : K974569 Trade Name: CoaguChek System (Professional Use) and CoaguChek PST (Patient Self Testing) Requlatory Class: II Product Code: JPA Dated: December 5, 1997 Received: December 8, 1997
Dear Mr. Naples:
We have reviewed your Section 510(k) notification of intent to market the CoaguChek System (Professional Use) and the CoaguChek PST (Patient Self Testing) devices under a single 510(k) number as referenced above and we have determined that these two devices are 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). Please note that the consolidation of these two devices under a single 510(k) number, K974569, does not change the fact that there are two separate and different intended uses for these devices, one for professional use and one for home use by prescription, and two different sets of quality control recommendations for the two devices. You may, therefore, market the devices, subject to the general controls The general controls provisions of provisions of the Act. the Act include requirements for annual registration, listing ... of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
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Page 2 - Mr. Richard Naples
If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 devices 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.
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), these devices 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 devices as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
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Page 3 - Mr. Naples
If you desire specific advice for your devices 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 devices, 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 Autman
Steven I. Gutman, MD,MBA 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): K974569
Device Names: CoaguChek System for Professional Use and the CoaguChek System for Patient Self Testing
Indications For Use:
The CoaguChek System for professional use is intended for quantitative prothrombin time (PT) testing in fresh capillary or venous whole blood by professional health care providers. The CoaguChek System for Patient Self Testing is intended for the quantitative prothrombin time (PT) testing in fresh capillary blood by selected and suitably trained patients or their caregivers on the prescription of the treating physician.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Steven Autman
(Division Sign-Off) Division of Clinical Laboratory Devi NG745 510(k) Number.
Prescription Use X (Per 21 CFR 801.109) OR
Over-The-Counter Use