(143 days)
Not Found
No
The description details a mechanical and optical system for detecting blood clotting time based on physical properties (blood flow stopping). There is no mention of algorithms that learn from data or adapt their behavior, which are characteristic of AI/ML.
No.
The device is for diagnostic purposes, specifically for measuring the activated clotting time of blood to monitor the effectiveness of heparin, and does not provide therapy or treatment.
Yes
The device quantitatively determines the activated clotting time of whole blood, which is a measurement used to monitor the effectiveness of heparin during medical procedures. This measurement helps healthcare professionals diagnose and manage a patient's coagulation status, making it a diagnostic device.
No
The device description clearly outlines a system that includes physical components like a test cartridge, an instrument with a laser optical system, and mechanisms for heating and detecting blood flow. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of the activated clotting time of freshly drawn whole blood." This is a test performed on a biological sample (whole blood) outside of the body to provide information about a patient's health status (coagulation).
- Device Description: The description details how the device analyzes a blood sample using a reagent and detects a clot. This process is characteristic of an in vitro diagnostic test.
- Sample Type: The device uses "freshly drawn whole blood," which is a biological specimen.
- Purpose: The test monitors the effectiveness of heparin, which is a medical treatment. The results of the test are used to guide patient care by helping healthcare professionals control heparin dosage.
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening.
N/A
Intended Use / Indications for Use
The CoaguChek Pro ACT test is for the quantitative determination of the activated clotting time of freshly drawn whole blood, using the CoaguChek Pro System.
The CoaguChek Pro ACT test cartridge is for the quantitative determination of the activated clotting time of freshly drawn whole blood, using the CoaguChek Pro System. It is intended for health care professional use only.
Product codes (comma separated list FDA assigned to the subject device)
JBP
Device Description
The activated clotting time test is used to measure coagulation by activating the clotting pathway. The ACT test monitors the effectiveness of heparin during several types of medical procedures. Many procedures such as Percutaneous Transluminal Coronary Angioplasty (PTCA), cardiac catheterization, hemodialysis, and Extracorporeal Membrane Oxygenation (ECMO) require the administration of low to moderate heparin doses. Sensitivity to heparin can vary significantly from patient to patient, and lack of adequate control of the heparin dose can lead to either bleeding or thrombosis.
The ACT test is initiated by inserting a CoaguChek Pro ACT test cartridge into the instrument. The instrument reads a code on the test cartridge to determine test identity and lot number. The test cartridge contains a sample application well, a reagent chamber, and a reaction path. After the instrument heats the test cartridge, a drop of fresh, whole blood is placed on the test cartridge sample application well. Blood is drawn into the reagent chamber by capillary action, where it mixes with the reagent to initiate coagulation. The blood sample moves along the reaction path until a clot forms. The laser optical system detects the clot by monitoring blood flow; endpoint is reached when the blood stops moving. The time from sample application to clot detection is the activated clotting time. The displayed result is equivalent to the ACT result obtained from a commercially available system. Because each newly-manufactured lot is calibrated to an internal reference lot, any lot-to-lot variability between reagents is corrected electronically using information coded on the lot-specific code key.
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
health care professional use only.
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)
Comparison of performance Performance characteristics characteristic claims for the CoaguChek Pro ACT test and the Hemochron ACT test:
Mean Normal:
Hemochron ACT Test: 132 seconds (Celite, healthy participants)
CoaguChek Pro ACT Test: 112 seconds 1.0 INR
Verified Hematocrit Range:
Hemochron ACT Test: Not in product labeling
CoaguChek Pro ACT Test: 27 – 54%
Precision with liquid controls:
Hemochron ACT Test: Not in product labeling, our studies gave:
Control Mean CV
Between-Day
Level 1 125.45 sec 12.36%
Level 2 261.08 sec 6.15%
CoaguChek Pro ACT Test:
Control Mean CV
Between-Day
Level 1 115.06 sec 5.79%
Level 2 401.02 sec 10.34%
Precision with blood:
Hemochron ACT Test: Not in product labeling
CoaguChek Pro ACT Test: Using arterial whole blood, duplicate results gave CVs of 6% or better.
Accuracy:
Hemochron ACT Test: Not in product labeling
CoaguChek Pro ACT Test: Arterial Whole Blood: CoaguChek Pro vs. Hemochron: N=539 Y=0.953X + 5.3 R=0.883
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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
JAN 1 4 2000
510(k) Summary
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
|---|---|
| 1) Submitter name, address, contact | Roche Diagnostics Corporation |
| 9115 Hague Rd. | |
| P.O. Box 50457 | |
| Indianapolis, IN 46250-0457 | |
| (317) 845-2000 |
Contact Person: Luann Ochs
Date Prepared: August 23, 1999 |
| 2) Device name | Proprietary name: ACT Test and Controls for the CoaguChek Pro System
Common name: activated clotting time test
Classification name: activated whole blood clotting time test |
| 3) Predicate device | We claim substantial equivalence to the International Technidyne Corporation ACT Test and controls for the Hemochron Whole Blood Coagulation System, K832189, K913861, K960749. |
Continued on next page
510(k) Summary
.
1
| 4) Device
Description | The activated clotting time test is used to measure coagulation by activating
the clotting pathway. The ACT test monitors the effectiveness of heparin
during several types of medical procedures. Many procedures such as
Percutaneous Transluminal Coronary Angioplasty (PTCA), cardiac
catheterization, hemodialysis, and Extracorporeal Membrane Oxygenation
(ECMO) require the administration of low to moderate heparin doses.
Sensitivity to heparin can vary significantly from patient to patient, and lack
of adequate control of the heparin dose can lead to either bleeding or
thrombosis.
The ACT test is initiated by inserting a CoaguChek Pro ACT test cartridge
into the instrument. The instrument reads a code on the test cartridge to
determine test identity and lot number. The test cartridge contains a sample
application well, a reagent chamber, and a reaction path. After the instrument
heats the test cartridge, a drop of fresh, whole blood is placed on the test
cartridge sample application well. Blood is drawn into the reagent chamber
by capillary action, where it mixes with the reagent to initiate coagulation.
The blood sample moves along the reaction path until a clot forms. The laser
optical system detects the clot by monitoring blood flow; endpoint is reached
when the blood stops moving. The time from sample application to clot
detection is the activated clotting time. The displayed result is equivalent to
the ACT result obtained from a commercially available system. Because each
newly-manufactured lot is calibrated to an internal reference lot, any lot-to-lot
variability between reagents is corrected electronically using information
coded on the lot-specific code key. |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5) Intended use | The CoaguChek Pro ACT test is for the quantitative determination of the
activated clotting time of freshly drawn whole blood, using the CoaguChek
Pro System. |
| 6) Comparison
to predicate
device | The Roche Diagnostics ACT Test and controls for the CoaguChek Pro
System is substantially equivalent to other products in commercial
distribution intended for similar use. Most notably it is substantially
equivalent to the currently marketed ACT Test and controls for the
Hemochron Whole Blood Coagulation System. |
.
Continued on next page
.
2
| Topic | Comment |
|---|---|
| Intended Use | Both are intended for the measurement of |
| activated clotting time in whole blood | |
| samples. | |
| Closed System | Both systems use instrument, reagent |
| carriers, and controls that are intended to be | |
| used together. | |
| Sample types | Both systems require nonanticoagulated |
| whole blood samples, either venous or | |
| arterial. | |
| Professional use | Both systems are indicated for use by health |
| care professionals at the point of care, not | |
| for over-the-counter or prescription self- | |
| testing. |
The CoaguChek Pro ACT Test and Controls is similar to the Hemochron
ACT test and controls in the following items:
Similarities to predicate device
Continued on next page
Roche Diagnostics August 23, 1999
3
Differences from predicate device
The following table lists the major differences between the CoaguChek Pro ACT Test and Controls and the predicate Hemochron ACT Test and Controls device:
| Topic | Hemochron ACT | CoaguChek Pro ACT |
|---|---|---|
| Operating principal | Dislocation of a | |
| precision aligned | ||
| magnetic rod by fibrin | ||
| fibers in the forming | ||
| clot. | Blood is drawn into the | |
| reagent chamber by | ||
| capillary action, where | ||
| it mixes with the | ||
| reagent. The blood | ||
| sample moves along the | ||
| reaction path until a | ||
| clot forms. | ||
| Detection system | Clot formation detected | |
| by a magnetic sensor | A laser optical system | |
| detects the clot by | ||
| monitoring blood flow. | ||
| Reagent carriers | Test tube containing an | |
| activator | Rigid plastic cartridge | |
| containing the reagents | ||
| in a reagent well | ||
| Sample volume | 2 mL | 45 µL drop of blood |
| ACT based on | Intrinsic pathway | Extrinsic pathway |
| Activator | Kaolin, celite, or glass | Tissue factor + sulfatide |
| Initiation of ACT | Surface activation of | |
| Factor XI via Factor | ||
| XIIa | Tissue factor / Factor | |
| VIIa complex | ||
| Sample/reagent mixing | Mixed manually by | |
| agitating the test tube | ||
| for 10 seconds | Automatic mixing | |
| while blood is | ||
| traversing the reagent | ||
| well | ||
| Heparin range | Every level of heparin | |
| anticoagulation, from | ||
| prophylaxis to intensive | 0-3 U/mL | |
| Maximal test time | 1,500 seconds | 500 seconds |
| Sensitive to aprotinin | Yes (Celite ACT only) | No |
Continued on next page
4
The following chart shows a comparison of performance Performance characteristics characteristic claims for the CoaguChek Pro ACT test and the Hemochron ACT test.
| Claim | Hemochron ACT Test
(Predicate) | CoaguChek Pro
ACT Test |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Mean Normal | 132 seconds (Celite, healthy
participants) | 112 seconds
1.0 INR |
| Verified Hematocrit
Range | Not in product labeling | 27 – 54% |
| Precision with liquid
controls | Not in product labeling, our
studies gave:
Control Mean CV
Between-Day
Level 1 125.45 sec 12.36%
Level 2 261.08 sec 6.15% | Control Mean CV
Between-Day
Level 1 115.06 sec 5.79%
Level 2 401.02 sec 10.34% |
| Precision with blood | Not in product labeling | Using arterial whole blood,
duplicate results gave CVs of 6%
or better. |
| Accuracy | Not in product labeling | Arterial Whole Blood:
CoaguChek Pro vs. Hemochron:
N=539
Y=0.953X + 5.3
R=0.883 |
5
Image /page/5/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines, which are meant to represent the human form.
JAN 1 4 2000
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Luann Ochs Regulatory Program Manager Roche Diagnostics Corporation 9115 Hague Road Indianapolis, Indiana 46250-0457
Re: K992851
Trade Name: ACT Test and Controls for the CoaguChek® Pro System Regulatory Class: II Product Code: JBP Dated: December 2, 1999 Received: December 3, 1999
Dear Ms. Ochs:
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 (OS) 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.
6
Page 2
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 Autman
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
7
510(k) Number (if known): Device Name: ACT Test and Controls for the CoaguChek Pro System Indications for Use:
The CoaguChek Pro ACT test cartridge is for the quantitative determination of the activated clotting time of freshly drawn whole blood, using the CoaguChek Pro System. It is intended for health care professional use only.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Petu E. Madin
(Division Sign-Off)
Division of Clinical Laboratory Devices K992851
510(k) Number.
Prescription Use Y (Per 21 CFR 801.109)
:
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Roche Diagnostics August 23, 1999
CONFIDENTIAL
22