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PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO SYSTEM

Q: Who is the manufacturer of PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO SYSTEM?

Roche Diagnostics Corp. filed the 510(k) submission for PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO SYSTEM (K992492).

Q: What is the FDA product code for PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO SYSTEM?

GJS. It is classified under 21 CFR 864.7750 as a Class 2 device in the Hematology panel.

Q: What is the regulatory pathway for PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO SYSTEM?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO SYSTEM?

CoaguChek PT Test and Controls (K992492).

K992492 · Roche Diagnostics Corp. · GJS · Nov 2, 1999 · Hematology

Device Facts

Record ID	K992492
Device Name	PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO SYSTEM
Applicant	Roche Diagnostics Corp.
Product Code	GJS · Hematology
Decision Date	Nov 2, 1999
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 864.7750
Device Class	Class 2

Intended 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.

Device Story

Device measures prothrombin time (PT) in whole blood to monitor coagulation; used by healthcare professionals in clinical settings. Input: drop of fresh whole blood applied to rigid plastic test cartridge. Operation: blood drawn into reagent chamber via capillary action; mixes with reagent to initiate coagulation; blood moves along reaction path. Laser optical system monitors blood flow; endpoint detected when blood stops moving. Instrument reads cartridge code for lot-specific calibration. Output: PT result displayed on monitor. Benefits: provides rapid, laboratory-equivalent PT results for patient management during anticoagulant therapy.

Clinical Evidence

Clinical accuracy evaluated by comparing CoaguChek Pro PTN results against MLA900C laboratory analyzer using 561 venous whole blood samples. Results showed high correlation (Y=0.974X + 0.12, R=0.922). Precision testing performed with controls and blood samples; control precision (CV) ranged from 5.2% to 11.6% depending on level and unit (sec/INR). Verified hematocrit range 23%-53%.

Technological Characteristics

Rigid plastic test cartridge containing reagent chamber and reaction path. Laser optical system for clot detection. Electronic calibration via lot-specific code key. Connectivity: instrument reads cartridge code. No maintenance required. Energy source: instrument-powered heating of cartridge.

Indications for Use

Indicated for quantitative determination of prothrombin time in freshly drawn whole blood (venous or capillary) for health care professional use. Used to monitor coagulation response in patients undergoing coumarin therapy or those with clotting factor deficiencies (II, V, VII, X).

Regulatory Classification

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).

Predicate Devices

CoaguChek PT Test and Controls (K992492)

Reference Devices

MLA700
MLA900C

Related Devices

K994349 — COAGUCHEK S SYSTEM, MODEL 2138280 · Roche Diagnostics Corp. · Sep 6, 2000
K974569 — COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING · Boehringer Mannheim Corp. · Jan 9, 1998
K992851 — ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM · Roche Diagnostics Corp. · Jan 14, 2000

Submission Summary (Full Text)

{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 0 030 {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 0 022