(143 days)
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.
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.
Here's a summary of the acceptance criteria and the study details for the ACT Test and Controls for the CoaguChek Pro System, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied vs. Predicate) | Reported Device Performance (CoaguChek Pro ACT Test) |
|---|---|---|
| Mean Normal | Similar to Predicate (132 seconds) | 112 seconds |
| Verified Hematocrit Range | Not in predicate labeling | 27 – 54% |
| Precision with Liquid Controls | Similar to Predicate | Level 1: Mean 115.06 sec, CV 5.79% |
| Level 2: Mean 401.02 sec, CV 10.34% | ||
| Precision with Blood | Not in predicate labeling | Using arterial whole blood, duplicate results gave CVs of 6% or better. |
| Accuracy | Not in predicate labeling | Arterial Whole Blood: |
| N=539 | ||
| Y = 0.953X + 5.3 | ||
| R = 0.883 (where Y is CoaguChek Pro and X is Hemochron) | ||
| Heparin Range | Predicate has "Every level of heparin anticoagulation, from prophylaxis to intensive" | 0-3 U/mL (a specified range, which is a difference from the predicate) |
| Maximal Test Time | Predicate is 1,500 seconds | 500 seconds (a difference from the predicate) |
Note: The document implies acceptance criteria by comparing the performance characteristics to a predicate device. Specific numerical "acceptance criteria" are not explicitly stated for each characteristic in the way they might be in a formal test plan. Instead, the comparison to the existing predicate device's performance (or lack thereof, for new metrics) serves as the basis for substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Accuracy: N=539 (for arterial whole blood comparison against the Hemochron).
- Precision with Blood: Not explicitly stated as a number of samples, but mentions "duplicate results."
- Precision with Liquid Controls: Not explicitly stated, implied to be sufficient for calculating Mean and CV for two levels.
- Data Provenance: Not explicitly stated but clinical studies are generally considered prospective or a mix. The document does not specify country of origin for the data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This device is an in-vitro diagnostic (IVD) based on measuring a physiological parameter (activated clotting time). The "ground truth" is established by the reading from a predicate device (Hemochron ACT Test) or by the inherent measurement of the physical phenomenon of clotting.
- Therefore, the concept of "experts establishing ground truth" in the same way it would apply to image interpretation (e.g., radiologists) does not directly apply here. The accuracy study compares the device's reading to that of a reference method (the predicate device).
4. Adjudication Method for the Test Set
- Not applicable as this is a quantitative measurement device compared against a predicate device, not an interpretation where multiple human experts would adjudicate a finding.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for diagnostic aids where human interpretation is involved.
- The study performed was a direct comparison of the device's quantitative output against a predicate device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, the study presented for "Accuracy" and "Precision" reflects the standalone performance of the CoaguChek Pro ACT Test system (instrument and cartridge). The device automatically detects the clot and reports the time, without human intervention in the measurement process itself, although a human initiates the test and reads the result.
7. The Type of Ground Truth Used
- Comparative Ground Truth: The primary "ground truth" for the accuracy study was the measurement obtained from the predicate device, the Hemochron ACT Test. The study aimed to show substantial equivalence through correlation.
- For precision, the "ground truth" is the reproducibility of the device's own measurements.
8. The Sample Size for the Training Set
- The document does not specify a separate "training set" size. For IVD devices like this, the development likely involves various stages of internal testing and calibration. The data presented here is for validation (test set).
9. How the Ground Truth for the Training Set Was Established
- Not described in the provided 510(k) summary. For devices of this nature, the "ground truth" for training (e.g., calibrating the device or developing the algorithm for clot detection) would typically involve using known samples or primary reference methods to ensure accurate and precise measurement of the activated clotting time.
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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 Corporation9115 Hague Rd.P.O. Box 50457Indianapolis, IN 46250-0457(317) 845-2000Contact Person: Luann OchsDate Prepared: August 23, 1999 |
| 2) Device name | Proprietary name: ACT Test and Controls for the CoaguChek Pro SystemCommon name: activated clotting time testClassification 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
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| 4) DeviceDescription | The activated clotting time test is used to measure coagulation by activatingthe clotting pathway. The ACT test monitors the effectiveness of heparinduring several types of medical procedures. Many procedures such asPercutaneous Transluminal Coronary Angioplasty (PTCA), cardiaccatheterization, 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 lackof adequate control of the heparin dose can lead to either bleeding orthrombosis.The ACT test is initiated by inserting a CoaguChek Pro ACT test cartridgeinto the instrument. The instrument reads a code on the test cartridge todetermine test identity and lot number. The test cartridge contains a sampleapplication well, a reagent chamber, and a reaction path. After the instrumentheats the test cartridge, a drop of fresh, whole blood is placed on the testcartridge sample application well. Blood is drawn into the reagent chamberby capillary action, where it mixes with the reagent to initiate coagulation.The blood sample moves along the reaction path until a clot forms. The laseroptical system detects the clot by monitoring blood flow; endpoint is reachedwhen the blood stops moving. The time from sample application to clotdetection is the activated clotting time. The displayed result is equivalent tothe ACT result obtained from a commercially available system. Because eachnewly-manufactured lot is calibrated to an internal reference lot, any lot-to-lotvariability between reagents is corrected electronically using informationcoded on the lot-specific code key. |
|---|---|
| 5) Intended use | The CoaguChek Pro ACT test is for the quantitative determination of theactivated clotting time of freshly drawn whole blood, using the CoaguChekPro System. |
| 6) Comparisonto predicatedevice | The Roche Diagnostics ACT Test and controls for the CoaguChek ProSystem is substantially equivalent to other products in commercialdistribution intended for similar use. Most notably it is substantiallyequivalent to the currently marketed ACT Test and controls for theHemochron Whole Blood Coagulation System. |
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| Topic | Comment |
|---|---|
| Intended Use | Both are intended for the measurement ofactivated clotting time in whole bloodsamples. |
| Closed System | Both systems use instrument, reagentcarriers, and controls that are intended to beused together. |
| Sample types | Both systems require nonanticoagulatedwhole blood samples, either venous orarterial. |
| Professional use | Both systems are indicated for use by healthcare professionals at the point of care, notfor 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
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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 aprecision alignedmagnetic rod by fibrinfibers in the formingclot. | Blood is drawn into thereagent chamber bycapillary action, whereit mixes with thereagent. The bloodsample moves along thereaction path until aclot forms. |
| Detection system | Clot formation detectedby a magnetic sensor | A laser optical systemdetects the clot bymonitoring blood flow. |
| Reagent carriers | Test tube containing anactivator | Rigid plastic cartridgecontaining the reagentsin 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 ofFactor XI via FactorXIIa | Tissue factor / FactorVIIa complex |
| Sample/reagent mixing | Mixed manually byagitating the test tubefor 10 seconds | Automatic mixingwhile blood istraversing the reagentwell |
| Heparin range | Every level of heparinanticoagulation, fromprophylaxis to intensive | 0-3 U/mL |
| Maximal test time | 1,500 seconds | 500 seconds |
| Sensitive to aprotinin | Yes (Celite ACT only) | No |
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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 ProACT Test |
|---|---|---|
| Mean Normal | 132 seconds (Celite, healthyparticipants) | 112 seconds1.0 INR |
| Verified HematocritRange | Not in product labeling | 27 – 54% |
| Precision with liquidcontrols | Not in product labeling, ourstudies gave:Control Mean CVBetween-DayLevel 1 125.45 sec 12.36%Level 2 261.08 sec 6.15% | Control Mean CVBetween-DayLevel 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=539Y=0.953X + 5.3R=0.883 |
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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.
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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
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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
§ 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).