(258 days)
No
The description details a mechanical method for detecting coagulation (movement of iron particles stopping) and does not mention any computational or learning-based algorithms.
No
The device is used for the quantitative determination of prothrombin time (PT) in fresh capillary or venous whole blood. This is a diagnostic function, not a therapeutic one. It monitors a patient's anticoagulant level, but does not administer therapy or directly treat a condition.
Yes
The device quantitatively determines prothrombin time (PT) in blood, which is a measurement used in the diagnosis and monitoring of bleeding disorders or the effectiveness of anticoagulant therapy.
No
The device description explicitly mentions a "CoaguChek S monitor" and "test strip" which are hardware components used in conjunction with the software to perform the PT test. The mechanism of action involves physical movement of iron particles and detection of coagulation, which is a hardware-dependent process.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "quantitative determination of prothrombin time (PT) in fresh capillary or venous whole blood". This involves testing a biological sample (blood) in vitro (outside the body) to obtain diagnostic information (PT values).
- Device Description: The description details how the device analyzes a blood sample using reagents and a physical process (monitoring iron particle movement) to determine a clinical parameter (PT). This is a hallmark of an in vitro diagnostic test.
- Performance Studies: The performance studies describe accuracy and precision when testing blood samples, further confirming its function as a diagnostic tool analyzing biological material.
The core function of the CoaguChek S System is to perform a test on a biological sample (blood) to provide diagnostic information about a patient's coagulation status. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
JPA
Device Description
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.
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
professional health care providers.
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
Accuracy:
Venous Whole Blood: CoaguChek S vs. MLA 700/1600
N=219
Y=0.935x + 0.004
R=0.904
Precision with controls:
Between-Day Control Mean CV
Level 1 14.9 sec 4.4% CV
Level 2 20.6 sec 5.2% CV
Precision with blood:
Capillary 19.4 sec 2.2% CV
Venous 19.3 sec 2.7% CV
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
SEP - 6 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: Jennifer Tribbett
Date Prepared: December 23, 1999 |
| 2) Device name | Proprietary name: CoaguChek ® S System
Common name: prothrombin time test
Classification name: Prothrombin time test |
| 3) Predicate
device | We claim substantial equivalence to the Roche Diagnostics Corporation
CoaguChek System, K930454. |
| 4) Device
Description | 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. |
| 5) Intended 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. |
| 6) Comparison
to predicate
device | The Roche Diagnostics CoaguChek S System is substantially equivalent to
other products in commercial distribution intended for similar use. Most
notably, it is substantially equivalent to the currently marketed Roche
Diagnostics CoaguChek System (K930454). |
| | Continued on next page |
1
ત દિ
2
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 contains | |
| reagents and iron particles. Blood mixes with these | |
| reagents and particles on the test strip. At the same | |
| time, the monitor starts a timer. The iron particles | |
| move 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, and |
| controls that are provided by Roche and are intended | |
| to be used together. | |
| PT Test Strips and | |
| Controls | Both systems use the same PT test strips, liquid |
| controls and electronic quality controls. | |
| Quality control | |
| procedure | The recommended liquid and electronic quality |
| control frequency is the same for both systems. | |
| Specimen collection | |
| and preparation | |
| instructions | These instructions are the same for both systems. |
| Calibration of results | Both systems are traceable to the WHO reference |
| method. |
3
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 |
|--------------------|----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Monitor
Display | Information is stated in text
format. | Information is stated in icon
format. |
| | For example: "Apply Sample"
is displayed to instruct the user
to apply a blood sample. | For example: A picture of a
test strip and a drop of blood is
displayed to instruct the user to
apply a blood sample. |
| Size | 8.8 x 5.5 x 2.2 inches
223.5 x 139.7 x 55.9 millimeters | 6.82 x 4.90 x 1.75 inches
173.2 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 |
4
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 |
|-----------------------|---------------------------------|---------------------------|
| 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 |
5
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-Day | |
| Control Mean CV | Between-Day | |
| Control 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 | Capillary | |
| 17.2 sec 2.2% CV | Capillary | |
| 19.4 sec 2.2% CV | ||
| Venous | ||
| 17.6 sec 1.9% CV | Venous | |
| 19.3 sec 2.7% CV | ||
| Accuracy | Venous Whole Blood: | |
| CoaguChek vs. MLA700 | Venous Whole Blood: | |
| CoaguChek S vs. MLA 700/1600 | ||
| N=81 | ||
| Y=0.859x + 1.3 | ||
| R=0.985 | N=219 | |
| Y=0.935x + 0.004 | ||
| R=0.904 |
6
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.
7
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
8
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter E. Makris
\frac{d}{d} \cdot g^L
OR
cratury Devices
Prescription Use
(Per 21 CFR 801.109)
C
Over-The-Counter Use
(Optional Format 1-2-96)
24
994349