(118 days)
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No
The summary describes a standard blood coagulation test system and does not mention any AI or ML terms or functionalities.
No
The device is used to monitor heparin anticoagulation, which is a diagnostic function, not a therapeutic one. It provides information about the patient's clotting time but does not directly treat or alleviate a medical condition.
Yes
The device is described as performing a "whole blood coagulation assay," which is a test to monitor a physiological process (heparin anticoagulation). Monitoring a physiological process to assess a patient's condition or response to treatment falls under the definition of a diagnostic device.
No
The description explicitly states "ActalykeR Mini™ Activated Clotting Time (ACT) Test System is used to perform the activated clotting time test". This implies a physical system (hardware) is involved in performing the test, not just software.
Yes, based on the provided information, the ActalykeR Mini™ Activated Clotting Time (ACT) Test System is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "whole blood coagulation assay" used to "monitor heparin anticoagulation." This involves testing a biological sample (whole blood) outside of the body to provide information about a patient's physiological state (coagulation).
- Nature of the Test: The ACT test is a laboratory test performed on a blood sample.
- Environment of Use: While it's intended for a "near-patient or patient-care environment," this doesn't preclude it from being an IVD. Many IVDs are designed for point-of-care use.
The definition of an IVD generally includes devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The ActalykeR Mini™ fits this description by analyzing a blood sample to monitor heparin levels, which is a form of patient monitoring.
N/A
Intended Use / Indications for Use
ActalykeR Mini™ Activated Clotting Time (ACT) Test System is used to perform the activated clotting time test, a whole blood coagulation assay commonly used to monitor heparin anticoagulation during various medical and surgical procedures. This unit is intended for professional use in a healthcare and home-care environment.
Product codes
JBP
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 use in a healthcare and home-care environment.
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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§ 864.7140 Activated whole blood clotting time tests.
(a)
Identification. An activated whole blood clotting time tests is a device, used to monitor heparin therapy for the treatment of venous thrombosis or pulmonary embolism by measuring the coagulation time of whole blood.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
A
JAN 1 0 2002
Ms. Pat Franks Assistant Director, Regulatory Affairs Helena Laboratories 1530 Lindbergh Drive P.O. Box 752 Beaumont, TX 77704-0752
K013078 Re:
ﺘ
Trade/Device Name: Actalyke Mini Regulation Number: 21 CFR 864.7140 Regulation Name: Activated whole blood clotting time tests Regulatory Class: Class II Product Code: JBP Dated: December 3, 2001 Received: December 5, 2001
Dear Ms. Franks:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 910(t) presidentially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to regars mannent date of the Medical Device American be of to commerce prior to May 26, 1776, the excerdance with the provisions of the Federal Food, Drug, devices that have been reculasinou in accessor al of a premarket approval application (PMA). and Cosmelle Act (Act) market the device, subject to the general controls provisions of the Act. The You may, dierelore, market the act include requirements for annual registration, listing of general controls provisions of wactice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (soo as on of the Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations an be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may be found in ano Obas neements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dr S issuates or or device complies with other requirements of the Act that I DA has made a acterimations administered by other Federal agencies. You must of any I edelal statutes and regulations and limited to: registration and listing (21 Compry with an the Act 3 requirements, news 801); good manufacturing practice requirements as set CFK Fatt 607); adomig (21 OFR Part 820); and if applicable, the electronic forth in the quality by sellions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) premarket I his lotten in and of your your 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 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at additionally 00711 o difficularly, for questions on the promotion and advertising of your device, (301) 59 nt ot the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/odrh/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
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Enclosure
2
of Page
510(k) Number (if known): K0/3078
Actalyke Mini Device Name:
Indications for Use:
ActalykeR Mini™ Activated Clotting Time (ACT) Test System is used to perform the activated clotting time test, a whole blood to periorm the accivated oreser. Sommitor heparin anticoagulation coagulation assay commonly and surgical procedures. This unit is during various mearcar and barger-care environment.
Josephine Buatista
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number- Kol3078
(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)
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