(258 days)
The CoaguChek S System is used for the quantitative determination of prothrombin time (PT) in fresh capillary or venous whole blood by professional health care providers.
The CoaguChek S System is used for the quantitative determination of prothrombin time (PT) in fresh capillary or venous whole blood by professional health care providers.
Blood coagulation is one of the body's protective responses. Blood clots (thrombi) form as a direct response to vessel injury, preventing excessive loss of blood. Certain disease conditions require oral anticoagulants, sometimes known as blood thinners. Warfarin, sometimes known as Coumadin ®, is a commonly used anticoagulant. People on warfarin must be carefully monitored to ensure the anticoagulant level is maintained in the therapeutic range. One method for monitoring the anticoagulant level is by using the one-stage Prothrombin Time (PT) Test. The CoaguChek Test Strip uses a modified version of this method.
The test strip, used as directed with the CoaguChek S monitor, will accurately measure blood PT values. After placing a drop of fresh whole blood on the test strip, the blood is drawn into the reaction chamber and mixed with reagents that cause coagulation to begin. In the test strip, tiny iron particles are mixed with the sample. Alternating magnetic fields cause the iron particles to move within the sample. The endpoint is reached when the blood clot stops the iron particles from moving. The PT result is then displayed by the monitor.
The provided 510(k) summary focuses on demonstrating substantial equivalence of the CoaguChek S System to its predicate device, the CoaguChek System (K930454). The study presented primarily involves a comparison of performance characteristics rather than establishing specific acceptance criteria and then proving the device meets them with a standalone study. However, we can infer acceptance criteria based on the comparison to the predicate.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" for the new device in a typical pass/fail format. Instead, it compares the performance of the CoaguChek S System to the predicate CoaguChek System. The implicit acceptance criteria are that the new device's performance should be comparable to or within acceptable limits of the predicate. We will present the performance characteristics as a comparison.
| Performance Characteristic | Implicit Acceptance Criteria (Comparable to Predicate) | CoaguChek S System Performance |
|---|---|---|
| Strip Related Claims (Same as Predicate) | ||
| Factor Sensitivity | Factors II, V, VII, and X | Factors II, V, VII, and X |
| Hematocrit Range | 32% - 52% | 32% - 52% |
| Reportable Range | 0.6 - 8.0 INR | 0.6 - 8.0 INR |
| Reagent Stability | 20 months | 20 months |
| Device Performance Claims | ||
| Precision (Between-Day Control Mean CV) | Level 1: 12.6 sec 3.7% CV (Predicate) | Level 1: 14.9 sec 4.4% CV |
| Level 2: 23.2 sec 4.1% CV (Predicate) | Level 2: 20.6 sec 5.2% CV | |
| Precision (Blood Sample) | Capillary: 17.2 sec 2.2% CV (Predicate) | Capillary: 19.4 sec 2.2% CV |
| Venous: 17.6 sec 1.9% CV (Predicate) | Venous: 19.3 sec 2.7% CV | |
| Accuracy (Venous Whole Blood vs. MLA 700/1600) | Y=0.859x + 1.3, R=0.985 (Predicate) | Y=0.935x + 0.004, R=0.904 |
Study Proving Acceptance:
The study presented is a comparative performance study between the CoaguChek S System and its predicate, the CoaguChek System.
2. Sample Size Used for the Test Set and Data Provenance:
- For Accuracy (Venous Whole Blood):
- Test Set Size: N=219
- Data Provenance: Not explicitly stated, but based on the nature of medical device testing for FDA submission, it would typically be prospective clinical or laboratory data collected in a controlled environment. The country of origin is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable in the context of this submission. The "ground truth" for the accuracy study is established by a reference laboratory method (MLA 700/1600), not by human expert consensus or adjudication.
4. Adjudication Method for the Test Set:
- Not applicable. The ground truth is established by a reference laboratory instrument (MLA 700/1600), so no human adjudication process is described or appears relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. This device is an automated diagnostic coagulation system, not an imaging device requiring human reader interpretation or assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:
- Yes, the performance characteristics provided (precision and accuracy) are standalone performance metrics for the CoaguChek S System (algorithm/device only). The accuracy is measured by comparing the device's results to a reference method (MLA 700/1600), quantifying the device's direct measurement capability.
7. The Type of Ground Truth Used:
- The ground truth for the accuracy study (the primary performance evaluation) was established by a reference laboratory instrument/method, specifically the MLA 700/1600 for Prothrombin Time.
8. The Sample Size for the Training Set:
- The document does not explicitly mention a "training set" or its sample size. For an IVD device like this, the development process would involve internal validation and optimization, but specific training set sizes for an algorithm (in the sense of AI/ML) are not detailed here, as the device relies on a chemical-mechanical principle ("dancing particle") rather than a complex AI model requiring extensive training data.
9. How the Ground Truth for the Training Set Was Established:
- As a training set is not explicitly mentioned, the method for establishing its ground truth is also not detailed. Device development typically involves rigorous in-house testing and validation against established reference methods or known controls, which serve as the "ground truth" during development and calibration, but these are not formally presented as a "training set" in this 510(k) summary.
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SEP - 6 2000
510(k) Summary
.
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. |
|---|---|
| 1) Submittername, address,contact | Roche Diagnostics Corporation9115 Hague Rd.P.O. Box 50457Indianapolis, IN 46250-0457(317) 845-2000 |
| Contact Person: Jennifer TribbettDate Prepared: December 23, 1999 | |
| 2) Device name | Proprietary name: CoaguChek ® S SystemCommon name: prothrombin time testClassification name: Prothrombin time test |
| 3) Predicatedevice | We claim substantial equivalence to the Roche Diagnostics CorporationCoaguChek System, K930454. |
| 4) DeviceDescription | The CoaguChek S System is used for the quantitative determination ofprothrombin time (PT) in fresh capillary or venous whole blood byprofessional health care providers. |
| Blood coagulation is one of the body's protective responses. Blood clots(thrombi) form as a direct response to vessel injury, preventing excessive lossof blood. Certain disease conditions require oral anticoagulants, sometimesknown as blood thinners. Warfarin, sometimes known as Coumadin ®, is acommonly used anticoagulant. People on warfarin must be carefullymonitored to ensure the anticoagulant level is maintained in the therapeuticrange. One method for monitoring the anticoagulant level is by using theone-stage Prothrombin Time (PT) Test. The CoaguChek Test Strip uses amodified version of this method. | |
| The test strip, used as directed with the CoaguChek S monitor, will accuratelymeasure blood PT values. After placing a drop of fresh whole blood on thetest strip, the blood is drawn into the reaction chamber and mixed withreagents that cause coagulation to begin. In the test strip, tiny iron particlesare mixed with the sample. Alternating magnetic fields cause the ironparticles to move within the sample. The endpoint is reached when the bloodclot stops the iron particles from moving. The PT result is then displayed bythe monitor. | |
| 5) Intended use | The CoaguChek S System is used for the quantitative determination ofprothrombin time (PT) in fresh capillary or venous whole blood byprofessional health care providers. |
| 6) Comparisonto predicatedevice | The Roche Diagnostics CoaguChek S System is substantially equivalent toother products in commercial distribution intended for similar use. Mostnotably, it is substantially equivalent to the currently marketed RocheDiagnostics CoaguChek System (K930454). |
| Continued on next page |
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Similaritics to predicate device
The CoaguChek S System is similar to the predicate CoaguChek System in the following items:
| Topic | Comment |
|---|---|
| Intended Use | Both are intended for quantitative prothrombin time(PT) testing in fresh capillary or venous whole blood. |
| Principle of Operation | Both systems utilize the same “dancing particle”principle of operation. The PT test strip containsreagents and iron particles. Blood mixes with thesereagents and particles on the test strip. At the sametime, the monitor starts a timer. The iron particlesmove in response to an oscillating magnetic field.When the blood clots, the particles stop moving. The monitor stops the timer and displays the result. |
| Closed System | Both systems use instrument, reagent strips, andcontrols that are provided by Roche and are intendedto be used together. |
| PT Test Strips andControls | Both systems use the same PT test strips, liquidcontrols and electronic quality controls. |
| Quality controlprocedure | The recommended liquid and electronic qualitycontrol frequency is the same for both systems. |
| Specimen collectionand preparationinstructions | These instructions are the same for both systems. |
| Calibration of results | Both systems are traceable to the WHO referencemethod. |
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Differences from predicate device
The following table lists the major differences between the CoaguChek S System and the predicate CoaguChek System.
| Topic | CoaguChek System(Predicate) | CoaguChek S System |
|---|---|---|
| MonitorDisplay | Information is stated in textformat. | Information is stated in iconformat. |
| For example: "Apply Sample"is displayed to instruct the userto apply a blood sample. | For example: A picture of atest strip and a drop of blood isdisplayed to instruct the user toapply a blood sample. | |
| Size | 8.8 x 5.5 x 2.2 inches223.5 x 139.7 x 55.9 millimeters | 6.82 x 4.90 x 1.75 inches173.2 x 124.5 x 44.5 millimeters |
| Weight | 1.5 lbs. or 0.68 kilograms(Including Batteries) | 1.0 lbs. or 0.454 kilograms(Including Batteries) |
| Memory | 30 test results with time & date | 60 test results with time & date |
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Strip related performance characteristics
.
Since the PT test strip utilized by the new CoaguChek S system and the Smeet the PT tool strip anness is the same, certain claims related directly to the production of impacted by the introduction of a new monitor. The following strip are not impacted by tte those strip related claims that will remain the same regardless of the monitor type used.
| Claim | CoaguChek System(Predicate) | CoaguChek S System |
|---|---|---|
| FactorSensitivity | Factors II, V, VII, and X | Factors II, V, VII, and X |
| HematocritRange | 32% - 52% | 32% - 52% |
| ReportableRange | 0.6 - 8.0 INR | 0.6 - 8.0 INR |
| ReagentStability | 20 months | 20 months |
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Performance characteristics
The following chart shows a comparison of performance characteristic claims for the CoaguChek S System and the CoaguChek System.
| Claim | CoaguChek System (Predicate) | CoaguChek S System |
|---|---|---|
| Precision with controls | Between-DayControl Mean CV | Between-DayControl Mean CV |
| Level 1 12.6 sec 3.7% CV | Level 1 14.9 sec 4.4% CV | |
| Level 2 23.2 sec 4.1% CV | Level 2 20.6 sec 5.2% CV | |
| Precision with blood | Capillary17.2 sec 2.2% CV | Capillary19.4 sec 2.2% CV |
| Venous17.6 sec 1.9% CV | Venous19.3 sec 2.7% CV | |
| Accuracy | Venous Whole Blood:CoaguChek vs. MLA700 | Venous Whole Blood:CoaguChek S vs. MLA 700/1600 |
| N=81Y=0.859x + 1.3R=0.985 | N=219Y=0.935x + 0.004R=0.904 |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 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" arranged around the perimeter. Inside the circle is a stylized graphic of an abstract human figure, represented by three curved lines that suggest a person in motion or reaching upwards.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Jennifer Tribbett Regulatory Affairs Specialist Roche Diagnostics Corporation 9115 Hague Road PO Box 50457 Indianapolis, Indiana 46250-0457
SEP 6 2000
K994349 Re: Trade Name: CoaguChek S System Regulatory Class: II Product Code: JPA Dated: June 7, 2000 Received: June 8, 2000
Dear Ms. Tribbett:
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 above und we nave assno as a loss and marketed predicate devices marketed in interstate commerce surved in the energians, to renactment date of the Medical Device Amendments, or to devices that provisions in the provisions with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Costions of the Act. The general controls provisions of the Act include requirements for annual provisions of the Frea - Preces, 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 (1 remarker ripproval), in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good A subbaniancers 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 mspotions, are a courage 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
This letter will allow you to begin marketing your device as described in your 510(k) premarket I inis letter will anow you to object maxantial equivalence of your device to a legally marketed noutication. The I Dr I mailig ssification 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 CFF) Part 801 and If you desire specific acrise is. Jagnostic devices), please contact the Office of Compliance at additionally 607.10 for mi ville diagnestions on the promotion and advertising of your device, (201) 594-4568. Truditionally, repliance 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 mioritiation on your rosponsibility free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrl/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
Enclosure
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K994349 510(k) Number (if known):
Device Name: CoaguChek S System
Indications for Use:
The CoaguChek S System is used for the quantitative determination of prothrombin time (PT) in fresh capillary or venous whole blood by professional health care providers.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter E. Makris
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Prescription Use
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Over-The-Counter Use
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24
994349
§ 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.