(99 days)
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Not Found
No
The description details a mechanical and optical process for detecting clot formation based on blood flow, with electronic correction for lot-to-lot variability. There is no mention of AI or ML algorithms being used for analysis or interpretation.
No
The device is described as a diagnostic tool for measuring prothrombin time, which helps monitor coagulation; it does not directly treat or alleviate a medical condition.
Yes
The device quantitatively determines prothrombin time, which is used to measure coagulation and monitor patients, thus providing information for diagnosing conditions affecting coagulation.
No
The device description clearly details a physical test cartridge, an instrument that heats the cartridge, and a laser optical system to detect clot formation. These are hardware components, not software.
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 prothrombin time of freshly drawn whole blood." This is a test performed in vitro (outside the body) on a biological sample (blood) to provide diagnostic information.
- Device Description: The description details how the device analyzes a blood sample using reagents and a detection system to measure a specific biological parameter (prothrombin time). This is the core function of an IVD.
- Nature of the Test: The prothrombin time test is a standard laboratory test used to assess blood coagulation, which is a diagnostic measurement.
- Regulatory Context: The information provided, including performance studies and predicate devices, is typical of documentation required for regulatory submission of an IVD.
The device fits the definition of an IVD as it is used to examine specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
The CoaguChek Pro PTN test is for the quantitative determination of the prothrombin time of freshly drawn whole blood, using the CoaguChek Pro System.
The CoaguChek Pro PTN test cartridge is for the quantitative determination of the prothrombin time of freshly drawn whole blood, using the CoaguChek Pro System. It is intended for health care professional use only.
Product codes
GJS
Device Description
The prothrombin time test is used to measure coagulation by activating the extrinsic pathway. The PTN test is sensitive to deficiencies of factors II, V, VII, and X. The prothrombin time is an in vitro determination of the time required for a clot to form via the extrinsic pathway. The prothrombin time is useful in monitoring the prolonged coagulation response of patients undergoing coumarin therapy. Many diseases and drugs can prolong or prevent coagulation by altering the balance of clotting factors involved in coagulation.
The PTN test is initiated by inserting a CoaguChek Pro PTN 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 prothrombin time. The displayed result is equivalent to laboratory plasma prothrombin time results. 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
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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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Accuracy:
Venous Whole Blood: CoaguChek Pro vs. MLA900C
N=561
Y=0.974X + 0.12
R=0.922
Mean Normal: 12 seconds, 1.0 INR
Verified Assay Range: 10.7 - 37.8 seconds, 0.8 - 9.9 INR
Factor Sensitivity: Factors II, V, VII, and X
Verified Hematocrit Range: 23% - 53%
Precision with controls:
Control Mean CV Between-Day
Level 1 11.6 sec 5.2%
0.9 INR 10.8%
Level 2 21.6 sec 5.5%
3.2 INR 11.6%
Precision with blood:
Capillary
17.7 sec 3.8% CV
2.31 INR 8.4% CV
Venous
18.6 sec 3.3% CV
2.57 INR 8.2% CV
Key Metrics
Not Found
Predicate Device(s)
Not Found (The text indicates substantial equivalence to the "currently marketed Roche Diagnostics PT Test and controls for the CoaguChek System" and "CoaguChek PT Test". However, no K/DEN number is provided for these devices.)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.7750 Prothrombin time test.
(a)
Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).(b)
Classification. Class II (performance standards).
0
992492
Nov - 2 1999
510(k) Summary, Continued
.
(
(
(
| 4) Device
Description | The prothrombin time test is used to measure coagulation by activating the
extrinsic pathway. The PTN test is sensitive to deficiencies of factors II, V,
VII, and X. The prothrombin time is an in vitro determination of the time
required for a clot to form via the extrinsic pathway. The prothrombin time is
useful in monitoring the prolonged coagulation response of patients
undergoing coumarin therapy. Many diseases and drugs can prolong or
prevent coagulation by altering the balance of clotting factors involved in
coagulation. |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The PTN test is initiated by inserting a CoaguChek Pro PTN 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 prothrombin time. The displayed result is equivalent to
laboratory plasma prothrombin time results. 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 PTN test is for the quantitative determination of the
prothrombin time of freshly drawn whole blood, using the CoaguChek Pro
System. |
| 6) Comparison
to predicate
device | The Roche Diagnostics PTN 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 Roche Diagnostics PT Test and controls for the
CoaguChek System. |
| | Continued on next page |
| Similarities to | |
| predicate | |
| device | |
1
510(k) Summary
The CoaguChek Pro PTN Test and Controls is similar to the CoaguChek PT Test and Controls in the following items:
| Topic | Comment |
|---|---|
| Intended Use | Both are intended for the measurement of prothrombin time in whole blood samples. |
| Closed System | Both systems use instrument, reagent carriers, and controls that are provided by Roche and are intended to be used together. |
| Sample types | Both systems require whole blood samples, either venous or capillary. |
| Professional use | Both systems are indicated for use by health care professionals, not for over-the-counter or prescription self-testing. |
| Quality control procedure | The use of the reconstituted liquid controls, or the electronic quality control cartridge is the same for both systems. |
| Specimen collection and preparation instructions | These instructions are the same for both systems. |
| Test reagent dosing | For both systems, the test reagent is dosed outside of the monitor, so that there is no need for cleaning of the cartridge or strip guide or the monitor optics. |
| Calibration of results | Both systems are traceable to the WHO reference method. |
| Maintenance | No maintenance is required for either system. |
Continued on next page
2
510(k) Summary, Continued
Differences from predicate device
The following table lists the major differences between the CoaguChek Pro PTN Test and Controls and the predicate CoaguChek PT Test and Controls device:
| Topic | CoaguChek PT | CoaguChek Pro PTN | |
|---|---|---|---|
| Operating principal | 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. | 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. The laser | |||
| optical system detects | |||
| the clot by monitoring | |||
| blood flow. | |||
| Reagent carriers | Reagent is housed | ||
| within a flexible plastic | |||
| strip. | Reagent is housed | ||
| within a rigid plastic | |||
| cartridge. |
Performance characteristics
The following chart shows a comparison of performance characteristic claims for the CoaguChek Pro PTN test and the CoaguChek PT test.
| Claim | CoaguChek
PT Test (Predicate) | CoaguChek Pro
PTN Test |
|-------------------------|--------------------------------------|--------------------------------------|
| Mean Normal | 12 seconds
1.0 INR | 12 seconds
1.0 INR |
| Verified Assay
Range | 9.6 - 34.4 seconds
0.64 - 8.2 INR | 10.7 - 37.8 seconds
0.8 - 9.9 INR |
| Factor Sensitivity | Factors II, V, VII, and X | Factors II, V, VII, and X |
Continued on next page
3
510(k) Summary, Continued
(
Performance characteristics (continued)
| Claim | CoaguChek
PT Test (Predicate) | CoaguChek Pro
PTN Test |
|---------------------------------|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Verified
Hematocrit
Range | 32% - 52% | 23% - 53% |
| Precision with
controls | Control Mean CV
Between-Day
Level 1 12.6 sec 3.7%
Level 2 23.2 sec 4.1% | Control Mean CV
Between-Day
Level 1 11.6 sec 5.2%
0.9 INR 10.8%
Level 2 21.6 sec 5.5%
3.2 INR 11.6% |
| Precision with
blood | Capillary
17.2 sec 2.2% CV
Venous
17.6 sec 1.9% CV | Capillary
17.7 sec 3.8% CV
2.31 INR 8.4% CV
Venous
18.6 sec 3.3% CV
2.57 INR 8.2% CV |
| Accuracy | Venous Whole Blood:
CoaguChek vs. MLA700
N=81
Y=0.859X + 1.3
R=0.985 | Venous Whole Blood:
CoaguChek Pro vs.
MLA900C
N=561
Y=0.974X + 0.12
R=0.922 |
の 2007年のアイデリアのアイデリアのアイデリアのアイデリアのアイデリアのアイデリアのアイデリアのアイデリア
Continued on next page
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4
Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal is circular and features an abstract design of an eagle with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged around the top of the circle, and the overall design is in black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
NOV - 2 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Luann Ochs Regulatory Program Manager Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457
K992492 Re:
Trade Name: P1N Test Cartridges and Controls for the CoaguChek Pro System Regulatory Class: II Product Code: GJS Dated: October 7, 1999 Received: October 8, 1999
Dear Ms. Ochs:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your becam b ro(i) its substantially equivalent (for the indications for use above and we nave determined the actested predicate devices marketed in interstate commerce stated in the enclosine) to legally manates of the Medical Device Amendments, or to devices that provision 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 Cosment Act (Act. Tournal), alorelers, listing in the Act include requirements for annual provisions of the Act. "The general othanifacturing practice, labeling, and prohibitions against misbranding and adultcration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (000 aco've) and additional controls. Existing major regulations (Frediation), it may to sayou in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good A substantially Cqurvalent determinations 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 inspections, the Pood and Drug Nammounting on the end on addition, FDA may publish
comply with the GMP regulation may result in regulatory action. In addition, FDA may publi Comply with the GMT Tegarater and your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might response to your prematited as a sub-Radiation Control provisions, or other Federal laws or regulations.
5
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it docs, 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, perroits 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 greeral 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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
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
6
510(k) Number (if known): K 99 3497 Device Name: PTN Test and Controls for the CoaguChek Pro System Indications for Use:
The CoaguChek Pro PTN test cartridge is for the quantitative determination of the prothrombin 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)
Peter E. Moani
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K992492
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use __________
(Optional Format 1-2-96)
Roche Confidential
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