DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110

K032573 · Dade Behring, Inc. · LAR · Oct 31, 2003 · Clinical Toxicology

Device Facts

• Record ID: K032573
• Device Name: DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110
• Applicant: Dade Behring, Inc.
• Product Code: LAR · Clinical Toxicology
• Decision Date: Oct 31, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3320
• Device Class: Class 2

Intended Use

The method is used on the Dade Behring Dimension clinical chemistry system for the quantitative determination of procainamide in serum or plasma. Measurements may be used in the diagnosis and treatment of procainamide overdose, and in therapeutic drug monitoring. The device is for in vitro diagnostic use. It is intended for prescription use.

Device Story

In vitro diagnostic test for quantitative procainamide measurement in serum or plasma; utilizes prepackaged flexible plastic reagent cartridges on Dimension clinical chemistry systems. Employs homogenous particle-enhanced turbidimetric inhibition immunoassay (PETINIA); procainamide in sample competes with latex-bound procainamide for monoclonal antibody binding sites; aggregation rate inversely proportional to procainamide concentration. System performs bichromatic turbidimetric readings at 340 nm and 700 nm. Used in clinical laboratory settings by trained personnel. Output provides procainamide concentration (ug/mL) to assist clinicians in therapeutic drug monitoring and overdose management.

Clinical Evidence

Bench testing only. Split-sample comparative study (n=89) between subject device and predicate (aca® PROC test pack) yielded a slope of 1.03, intercept of -0.02 ug/mL, and correlation coefficient of 0.997.

Technological Characteristics

PETINIA immunoassay; latex particle procainamide conjugate; monoclonal procainamide-specific antibody. Bichromatic turbidimetric detection (340 nm/700 nm). Form factor: flexible plastic reagent cartridge for Dimension clinical chemistry system. Assay range: 0.5 - 20.0 ug/mL. Sample volume: 2 uL.

Indications for Use

Indicated for the quantitative measurement of procainamide in serum or plasma for patients undergoing procainamide therapy or suspected of procainamide overdose.

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

• Dade Behring aca® PROC analytical test pack (K833384)

Submission Summary (Full Text)

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### Summary of Safety and Effectiveness Information

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| Submitter's Name: | Richard M. Vaught<br>Dade Behring Inc.<br>P.O. Box 6101<br>Newark, DE 19714-6101 |
|--------------------------|----------------------------------------------------------------------------------|
| Date of Preparation: | August 19, 2003 |
| Name of Product: | Dimension® Procainamide (PROC) Flex® reagent cartridge method |
| FDA Classification Name: | Procainamide test system (21CFR§862.3320; 91LAR) |
| Predicate Device: | Dade Behring aca® PROC analytical test pack (K833384) |

#### Device Description:

The Dade Behring Dimension® Procainamide (PROC) Flex® reagent cartridge method is an in vitro diagnostic test that consists of prepackaged reagents in a flexible plastic cartridge for use only on the Dimension® clinical chemistry system. The Dimension® PROC Flex® reagent cartridge assay is based on a homogenous particle-enhanced turbidimetric inhibition immunoassay (PETINIA) which uses a latex particle procainamide conjugate and monoclonal procainamide specific antibody. Procainamide present in the sample competes with procainamide on the particles for available antibody, thereby decreasing the rate of aggregation. Hence, the rate of aggregation is inversely proportional to the concentration of procainamide in the sample. The rate of aggregation is measured using bichromatic turbidimetric readings at 340 nm and 700 nm.

#### Intended Use:

The Dimension® Procainamide (PROC) Flex® reagent cartridge method is used for the quantitative determination of procainamide in serum or plasma. Measurements may be used in the diagnosis and treatment of procainamide overdose, and in therapeutic drug monitoring.

#### Comparison to Predicate Device:

A summary of the features of the Dade Behring Dimension® PROC Flex® reagent cartridge method and the predicate device, the Dade Behring aca® PROC analytical test pack (K833384) is provided in the following chart:

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| | Dimension® PROC Flex® cartridge | aca® PROC analytical test pack |
|--------------|---------------------------------------------------|---------------------------------------|
| Intended Use | in vitro diagnostic use | in vitro diagnostic use |
| Assay Range | 0.5 - 20.0 ug/mL | 1.0 - 16.0 ug/mL |
| Sample size | 2 uL | 40 uL |
| Measurement | PETINIA<br>turbidimetric rate<br>340 nm and 700nm | EMIT®1<br>colorimetric rate<br>340 nm |

【 Registered trademark of Syva Company, Dade Behring Inc.

Split-sample comparative performance was evaluated between the Dade Behring Dimension® PROC Flex® method and the predicate aca® PROC analytical test pack method. The results are summarized below:

| Comparative<br>Method | Slope | Intercept<br>(ug/mL) | Correlation<br>Coefficient | n |
|-------------------------------------|-------|----------------------|----------------------------|----|
| Dade Behring<br>aca® PROC test pack | 1.03 | -0.02 | 0.997 | 89 |

#### Comments on Substantial Equivalence:

Both Dade Behring products, the Dimension® Procainamide (PROC) Flex® reagent cartridge method and the aca® PROC analytical test pack method are homogenous immunoassays intended for the quantitative determination of procainamide in serum or plasma. Split-sample comparative data demonstrates good agreement (correlation) between the methods.

#### Conclusion:

The Dade Behring Dimension® Procainamide (PROC) Flex® reagent cartridge method and the predicate Dade Behring aca® PROC analytical test pack method (K833384) are substantially equivalent based on their intended use, design and comparison performance characteristics as described above.

> Richard M. Vaught Regulatory Affairs and Compliance Manager August 19, 2003

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Image /page/2/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the edge. In the center of the logo is a symbol that looks like three curved lines stacked on top of each other. The logo is black and white.

OCT 3 1 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Richard M. Vaught Regulatory Affairs and Compliance Manager Dade Behring Inc. Glasgow Business Community Bldg. 500, M.S. 514 P.O. Box 6101 Newark, DE 19714-6101

Re: k032573

Trade/Device Name: Dimension® Procainamide (PROC) Flex® reagent cartridge method Regulation Number: 21 CFR 862.3320 Regulation Name: Digoxin test system Regulatory Class: Class II Product Code: LAR Dated: August 19, 2003 Received: August 20, 2003

Dear Mr. Vaught:

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 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) 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 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 (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 that 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 comply with all the Act's requirements, 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) r morket 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 Sutman

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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## Indications For Use Statement

Device Name:

Dimension® Procainamide (PROC) Flex® reagent cartridge method

Indications for Use:

The Dade Behring Dimension® Procainamide (PROC) Flex® reagent cartridge method is used to measure procainamide in serum or plasma. Measurements obtained may be used in the diagnosis and treatment of procainamide overdose and in monitoring levels of procainamide to ensure appropriate therapy.

R.M. Vaught
Richard M. Vaught

Regulatory Affairs and Compliance Manager

August 19, 2003

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per 21 CFR 801.109)
✓

OR

Over-the-counter Use

(Optional format 1-2-96)

Nberto Saly
**Division Sign-Off** for Jean Cooper

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K032573

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