COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P

K983892 · Roche Diagnostics/Boehringer Mannheim GmbH · JPA · Apr 13, 1999 · Hematology

Device Facts

• Record ID: K983892
• Device Name: COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P
• Applicant: Roche Diagnostics/Boehringer Mannheim GmbH
• Product Code: JPA · Hematology
• Decision Date: Apr 13, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

The CoaguChek Pro APTT test is for the quantitative determination of the activated partical thromboplastin time (APTT) of freshly drawn whole blood. It is intended for health care professional use only.

Device Story

CoaguChek Pro System is a point-of-care diagnostic device for measuring APTT in whole blood. System consists of a monitor and single-use reagent test cartridges. User applies a drop of fresh whole blood to the cartridge sample well; capillary action draws blood into a reagent chamber to initiate coagulation. A laser optical system monitors blood flow along a reaction path; endpoint is detected when blood movement stops. The instrument reads a lot-specific code key to calibrate results. Designed for professional clinical use; provides quantitative APTT results equivalent to laboratory plasma methods. Benefits include rapid coagulation screening and heparin therapy monitoring at the point of care.

Clinical Evidence

Performance supported by comparative bench testing. Accuracy evaluated across three clinical sites (n=55, n=54, n=45) comparing CoaguChek Pro results to laboratory plasma methods. Precision evaluated using controls; overall CVs reported as 5.3% (Level 1) and 4.7% (Level 2). Verified assay range is 18-150 seconds. Hematocrit range verified at 26.5% - 53%.

Technological Characteristics

System utilizes laser optical detection of clot formation in a capillary-action reagent cartridge. Operates as a closed system with proprietary reagent cartridges and electronic/liquid controls. Features include lot-specific calibration via code key. Monitor provides self-diagnostic messaging. No maintenance required. Software performs automated clot detection and result calculation.

Indications for Use

Indicated for quantitative determination of activated partial thromboplastin time (APTT) in freshly drawn whole blood (venous or capillary) for health care professional use. Used to evaluate intrinsic pathway function and monitor heparin therapy.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Biotrack monitor and APTT test cartridges and controls (K860720, K890052, K890051), also known as Roche Diagnostics CoaguChek Plus System

Submission Summary (Full Text)

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4/13/99

K983892

**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 | Boehringer Mannheim Corporation, doing business as Roche Diagnostics<br>9115 Hague Rd.<br>Indianapolis, IN 46256<br>[phone]<br>Contact Person: Luann Ochs |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Date Prepared: October 30, 1998 |
| 2) Device name | Proprietary name: CoaguChek Pro System, APTT Test and Controls<br>Common name: Activated partial thromboplastin test<br>Classification name: Multipurpose system for <i>in vitro</i> coagulation studies |
| 3) Predicate device | We claim substantial equivalence to the Biotrack monitor and APTT test cartridges and controls, K860720, K890052, K890051. The Biotrack system is also known as the Roche Diagnostics CoaguChek Plus System, APTT test and controls. |

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The APTT is used to evaluate intrinsic pathway function. The APTT is 4) Device Description sensitive to deficiencies of factors VIII, IX, XI, and XII, prekallikrein, high molecular weight kinogen, as well as common pathway factors (II, V, X, and fibrinogen). The APTT is useful as a screening test for coagulation function, since it is sensitive to all coagulation factors except VII, platelet factor III and calcium. Additionally, the APTT is used to monitor the effectiveness of heparin therapy. Many diseases and drugs can prolong or prevent coagulation by altering the balance of clotting factors involved in coagulation. The APTT test is initiated by inserting a CoaguChek Pro APTT 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 APTT. The displayed result is equivalent to laboratory plasma APTT 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 APTT test is for the quantitative determination of the activated partial thromboplastin time (APTT) of freshly drawn whole blood. 6) Comparison The Roche Diagnostics CoaguChek Pro System, APTT Test and controls, is to predicate substantially equivalent to other products in commercial distribution intended device for similar use. Most notably it is substantially equivalent to the currently marketed Roche Diagnostics CoaguChek Plus System, APTT Test and controls.

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The CoaguChek Pro is similar to the CoaguChek Plus in the following items: Similarities to predicate device

| Topic | Comment |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Both are intended for the measurement of activated partial thromboplastin time in whole blood samples. |
| Closed System | Both systems use only the instrument, reagent cartridges, and controls (liquid and electronic) 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. |
| Operating principle | Both systems use the same instrument and reagent operating principles. Instrument operating conditions are also unchanged. |
| Reagent Test Cartridges | The APTT Reagent Test cartridges are exactly the same for both monitor systems. Test cartridge design, packaging (individually foil wrapped), calibration, and storage conditions are identical. |

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Similarities to predicate device (continued)

| Topic | Comment |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Assay procedure | The whole blood testing procedure is unchanged. |
| 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 cartridge dosing | For both systems, the test cartridge is dosed outside of the monitor, so that there is no need for cleaning of the cartridge guide or the monitor optics. |
| Maintenance | No maintenance is required for either monitor. |
| Limitations | The limitations of the procedure remain unchanged between the systems. |
| Unusual results | The instructions for action required when unusual results are obtained are the same for both systems. |
| Warnings and precautions | Warnings and precautions are unchanged. |
| Calibration of results | Test results for both methods were originally calibrated to laboratory plasma method. |

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Differences from predicate device

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The following table lists the major differences between the CoaguChek Pro and the predicate CoaguChek Plus device:

| Topic | Comment |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Assays | At this time, we are only submitting the APTT test for use on the CoaguChek Pro monitor. Future tests will be submitted as separate 510(k)s. The CoaguChek Plus System includes APTT as well as a PT (prothrombin time) test. |
| Instrument models | The CoaguChek Plus System is available with one model of monitor. The CoaguChek Pro System will be available as a base model, a direct replacement for the Plus monitor, and a DM model. The DM model includes options for use in professional settings where data reporting features are required. |
| Monitor displayed self-diagnostic messages. | While both monitors provide self-diagnostic messages, the CoaguChek Plus has 22 such messages, while the CoaguChek Pro has 16 self-test messages and 29 other diagnostic messages. Please refer to the appropriate operator's manuals for the listings of the messages. |

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Performance characteristics The following chart shows a comparison of performance characteristic claims for the CoaguChek Pro APTT test and the CoaguChek Plus APTT test. Data to support the claims for the CoaguChek Pro is included in this 510(k), in section IV.

| Claim | CoaguChek Plus<br>APTT Test (Predicate) | CoaguChek Pro<br>APTT Test |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Mean Normal | 31 seconds | 31 seconds |
| Verified Assay<br>Range | 18 - 150 seconds | 18 - 150 seconds |
| Displayed Assay<br>Range | 18 - 150 seconds | 18 - 150 seconds |
| Factor Sensitivity | Factors VIII, IX, XI, XII,<br>prekallikrein, and<br>kininogen. | Factors VIII, IX, XI, XII,<br>prekallikrein, and<br>kininogen. |
| Verified<br>Hematocrit<br>Range | 25.5% - 53% | 26.5% - 53% |
| Precison with<br>controls | Control Mean CV<br><i>Within-Day</i><br>Level 1 55.5 sec 4.7%<br>Level 2 116.1 sec 4.5%<br><i>Between-Day</i><br>Level 1 56.2 sec 5.8%<br>Level 2 116.8 sec 3.8% | Control Mean CV<br><i>Overall</i><br>Level 1 44.2 sec 5.3%<br>Level 2 83.4 sec 4.7% |
| Accuracy | Center A, n = 73<br>$y = 1.24 x - 9.9, r = 0.78$<br>Center B, n=71<br>$y = 1.54 x - 22.5, r = 0.87$<br>Center C, n=59<br> | Site 1, n = 55<br>$y = 0.792 x + 8.5, r = 0.89$<br>Site 2, n = 54<br>$y = 1.134 x - 0.8, r = 0.93$<br>Site 3, n = 45 |

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Public Health Service

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Re:

APR 1 3 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Luann Ochs Regulatory Program Manager Roche Diagnostics 9115 Hague Road Indianapolis, Indiana 46256

> K983892 Trade Name: CoaguChek Pro System, APTT Test and Controls Regulatory Class: II Product Code: JPA Dated: February 5, 1999 Received: February 8, 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 (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 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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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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K983892

510(k) Number (if known): Device Name: CoaguChek Pro System, APTT Test and Controls Indications for Use:

The CoaguChek Pro APTT test is for the quantitative determination of the activated partical thromboplastin time (APTT) of freshly drawn whole blood. It is intended for health care professional use only.

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#### Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter E. Madeni

(Division Sign-Off) Division of Clinical Laboratory Devices 610(k) Numiber _______________________________________________________________________________________________________________________________________________________________

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use _______

(Optional Format 1-2-96)

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