ROCHE ONLINE TDM QUINIDINE

K032332 · Roche Diagnostics Corp. · LBZ · Jan 12, 2004 · Clinical Toxicology

Device Facts

• Record ID: K032332
• Device Name: ROCHE ONLINE TDM QUINIDINE
• Applicant: Roche Diagnostics Corp.
• Product Code: LBZ · Clinical Toxicology
• Decision Date: Jan 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3320
• Device Class: Class 2

Intended Use

The Roche ONLINE TDM Quinidine assay is for the quantitative determination of quinidine in human serum or plasma on automated clinical analyzers. Quinidine is used for the prevention and treatment of ventricular arrhythmias, junctional (nodal) arrhythmias and supraventricular (atrial) arrhythmias. The quinidine dosage required to achieve therapeutic serum levels is dependent on the drug formulation, patient age and individual variability in absorption and metabolism. The proposed labeling indicates the Roche/Hitachi 911, 912, 917 and Modular P analyzers can be used with the Roche ONLINE Quinidine reagent kits.

Device Story

The Roche ONLINE TDM Quinidine assay is a homogeneous immunoassay used on automated clinical chemistry analyzers to measure quinidine levels in human serum or plasma. The device utilizes microparticles coated with quinidine and a quinidine antibody solution. In the absence of sample quinidine, the antibody promotes microparticle aggregation, increasing scattered light or absorbance. When sample quinidine is present, it binds to the antibody, inhibiting microparticle aggregation in a concentration-dependent manner. By monitoring the change in scattered light or absorbance, the device generates a concentration-dependent inhibition curve. The assay is operated by laboratory personnel in a clinical setting. The resulting quantitative measurement assists healthcare providers in monitoring therapeutic drug levels, which vary based on patient age, individual variability, and formulation, thereby aiding in the management of cardiac arrhythmias.

Clinical Evidence

Bench testing only. Performance was evaluated through precision studies and method comparison against the predicate device (N=150). Results showed a correlation of R=0.991 with a regression equation of Y=1.054X-0.036. Precision studies (within-run and total CV%) were conducted at three levels, with total CV% ranging from 2.7% to 3.9%. Specificity and interfering substances were also assessed, confirming performance equivalence to the predicate.

Technological Characteristics

Homogeneous microparticle immunoassay. Reagents: anti-quinidine monoclonal antibody, quinidine-derivative microparticles, buffers, preservatives. Detection: scattered light measurement via automated clinical chemistry analyzers. Reportable range: 0.09-8.0 ug/ml. Matrix compatibility: serum, EDTA plasma, sodium heparin plasma, lithium heparin plasma.

Indications for Use

Indicated for the quantitative determination of quinidine in human serum or plasma to assist in the management of ventricular, junctional (nodal), and supraventricular (atrial) arrhythmias. Intended for use on automated clinical chemistry analyzers.

Regulatory Classification

Identification

A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.

Predicate Devices

• Roche Cobas Integra Quinidine (K951595)

Submission Summary (Full Text)

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K032332

## JAN 1 2 2004

## Roche ONLINE Quinidine Assay

## 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. Indianapolis, IN 46250 [phone] Contact Person: Mike Flis Date Prepared: July 28, 2003 |
| 2) Device name | Roche ONLINE TDM Quinidine |
| 3) Predicate device | We claim substantial equivalence to the Roche COBAS INTEGRA Quinidine [K951595]. |
| 4) Device Description | The assay is a homogeneous immunoassay based on the principle of measuring changes in scattered light or absorbance which result when activated microparticles aggregate. The microparticles are coated with quinidine and rapidly aggregate in the presence of a quinidine antibody solution. When a sample containing quinidine is introduced, the aggregation reaction is partially inhibited, slowing the rate of the aggregation process. Antibody bound to sample drug is no longer available to promote microparticle aggregation, and subsequent particle lattice formulation is inhibited. Thus, a classic inhibition curve with respect to quinidine concentration is obtained, with the maximum rate of aggregation at the lowest quinidine concentration. By monitoring the change in scattered light or absorbance, a concentration-dependent curve is obtained. |

Continued on next page

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### 510(k) Summary, Continued

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| 5) Intended use | For the quantitative determination of quinidine in human serum or plasma on automated clinical chemistry analyzers. |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6) Comparison to predicate device | The Roche ONLINE TDM Quinidine was evaluated for several performance characteristics, including precision, lower detection limit, method comparison, specificity, and interfering substances. All of the evaluation studies gave acceptable results compared to the predicate device. These experiments provide evidence that the Roche ONLINE TDM Quinidine is substantially equivalent to the currently marketed Roche COBAS INTEGRA Quinidine Assay. The following table presents the precision and method comparison results. |

| Roche ONLINE TDM Quinidine | Roche COBAS INTEGRA Quinidine, |
|----------------------------|--------------------------------|
|----------------------------|--------------------------------|

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and the control control control control controllers.

: .

| Roche ONLINE TDM Quinidine | | | Roche COBAS INTEGRA Quinidine,<br>(Predicate labeling) | | | |
|-----------------------------------------------------------------|---------|---------|--------------------------------------------------------|---------|---------|---------|
| Versus Roche COBAS INTEGRA Quindine<br>Assay (predicate device) | | | Versus Enzyme Immunoassay | | | |
| N = 150 | | | N = 154 | | | |
| Y = $1.054X-0.036$ | | | Y = $0.941X - 0.024$ | | | |
| R = 0.991 | | | R = 0.991 | | | |
| Range = 0.22 to 7.04 µg/mL | | | Range = 0.16 to 5.7 µg/mL | | | |
| NCCLS<br>Precision: | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 |
| Mean (µg/mL) | 0.93 | 2.87 | 4.61 | 1.35 | 3.47 | 5.42 |
| CV% (within run) | 2.0 | 1.3 | 1.2 | 2.1 | 2.2 | 2.0 |
| CV% (total) | 3.9 | 2.7 | 2.7 | 3.2 | 3.5 | 3.2 |

and the comments of the comments of the comments of

:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features a stylized eagle with three stripes on its wing, representing health, hope, and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administratio 2098 Gaither Road Rockville MD 20850

JAN 1 2 2004

Mr. Mike Flis Regulatory Affairs Principal Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, In 46250-0457

k032332 Re:

Trade/Device Name: Roche ONLINE TDM Quinidine Assay Regulation Number: 21 CFR 862.3320 Regulation Name: Digoxin test system Regulatory Class: Class II Product Code: LBZ Dated: October 31, 2003 Received: November 4, 2003

Dear Mr. Flis:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associor 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, ateres 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r hat FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must of any I edolul statuates and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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 Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Roche Diagnostics Corporation

510(k) Number (if known): 510(R) Name: Roche ONLINE TDM Quinidine Assay Indications for Use:

The Roche ONLINE TDM Quinidine assay is for the quantitative determination of quinidine in human serum or plasma on automated clinical chemistry analyzers. Quinidine is used for the numan sorant of practicular arththmias, junctional (nodal) arrhythmias, and supraventricular (atrial) arrhythmias. The quinidine dosage required to achieve therapeutic supraventicular (urrry annos) formulation, patient age, and individual variability in 2010, 0 Scruit levels is depondent on the proposed labeling indicates the Roche/Hitachi 911, 912, 917, and Modular P analyzers can be used with the Roche ONLINE Quinidine reagent kits.

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| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| Prescription Use (Per 21 CFR 801.109) | <div style="display:flex; align-items:center;"> <span style="margin-right: 50px;"></span> <span style="margin-left: 50px;">OR</span> </div> | Over-The-Counter Use ______ |
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| Division Sign-Off | (Optional Format 1-2-96) |
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Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K032332