DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111

K032564 · Dade Behring, Inc. · LAN · Oct 31, 2003 · Clinical Toxicology

Device Facts

• Record ID: K032564
• Device Name: DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111
• Applicant: Dade Behring, Inc.
• Product Code: LAN · Clinical Toxicology
• Decision Date: Oct 31, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3320
• Device Class: Class 2

Intended Use

The NAPA method is used on the Dimension clinical chemistry system for the quantitative determination of N-acetylprocainamide in serum or plasma. N-acetylprocainamide measurements may be used in therapeutic drug monitoring to maintain adequate procainamide therapy. The device is for in vitro diagnostic use. It is intended for prescription use.

Device Story

The Dimension NAPA Flex reagent cartridge is an in vitro diagnostic assay for quantitative determination of N-acetylprocainamide (NAPA) in serum or plasma. It is designed for use on automated Dimension clinical chemistry systems. The device uses a homogeneous particle-enhanced turbidimetric inhibition immunoassay (PETINIA) principle; NAPA in the patient sample competes with latex-bound NAPA for monoclonal antibodies, reducing aggregation rates. The system measures aggregation via bichromatic turbidimetric readings at 340nm and 700nm. Results are calculated via standard curve extrapolation. The assay is operated by laboratory personnel in a clinical setting. Output is a quantitative concentration value used by clinicians to monitor therapeutic drug levels and adjust procainamide therapy.

Clinical Evidence

No clinical studies performed. Bench testing only. Method comparison study (n=73 split serum samples) against predicate yielded slope 0.96, intercept -0.03, and correlation coefficient 0.993. Precision (NCCLS EP5-A) demonstrated total CVs ranging from 1.4% to 6.0%. Analytical sensitivity is 0.5 μg/mL. Linearity range 0.5–30.0 μg/mL.

Technological Characteristics

PETINIA immunoassay; uses latex particle NAPA conjugate and monoclonal NAPA-specific antibody. Bichromatic turbidimetric detection at 340 nm and 700 nm. Reagents provided in flexible plastic cartridge for use on Dimension clinical chemistry systems.

Indications for Use

Indicated for the quantitative measurement of N-acetylprocainamide in serum or plasma for therapeutic drug monitoring to maintain adequate procainamide therapy.

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® NAPA analytical test pack (K833378)

Submission Summary (Full Text)

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K032564

# OCT 3 1 2003

## 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® N-acetylprocainamide (NAPA) Flex® reagent cartridge<br>method |
| FDA Classification Name: | N-acetylprocainamide test system (21CFR§862.3320; 91LAR) |
| Predicate Device: | Dade Behring aca® NAPA analytical test pack (K833378) |

### Device Description:

The Dade Behring Dimension® N-acetylprocainamide (NAPA) 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® NAPA Flex® reagent cartridge assay is based on a homogenous particle-enhanced turbidimetric inhibition immunoassay (PETINIA) which uses a latex particle N-acetylprocainamide conjugate and monoclonal N-acetylprocainamide specific antibody. Nacetylprocainamide present in the sample competes with N-acetylprocainamide on the particles for available antibody, thereby decreasing the rate of aggregation. Hence, the rate of aggregation is inversely proportional to the concentrtion of N-acetyl procainamide in the sample. The rate of aggregation is measured using bichromatic turbidimetric readings at 340 nm and 700 nm.

#### Intended Use:

The Dimension® N-acetylprocainamide (NAPA) Flex® reagent cartridge method is used for the quantitative determination of N-acetylprocainamide in serum or plasma. Measurements may be used in therapeutic drug monitoring to maintain adequate procainamide therapy.

### Comparison to Predicate Device:

A summary of the features of the Dade Behring Dimension® NAPA Flex® reagent cartridge method and the predicate device, the Dade Behring aca® NAPA analytical test pack (K833378) is provided in the following chart:

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| | Dimension® NAPA Flex® cartridge | aca® NAPA analytical test pack |
|--------------|---------------------------------------------|---------------------------------|
| Intended Use | in vitro diagnostic use | in vitro diagnostic use |
| Assay Range | 0.5 - 30.0 ug/mL | 1.0 - 16.0 ug/mL |
| Sample size | 2 uL | 40 uL |
| Measurement | PETINIA turbidimetric rate 340 nm and 700nm | EMIT®1 colorimetric rate 340 nm |

1 Registered trademark of Syva Company, Dade Behring Inc.

Split-sample comparative performance was evaluated between the Dade Behring Dimension® NAPA Flex® method and the predicate aca® NAPA method and the results are summarized below:

| Comparative<br>Method | Slope | Intercept<br>(ug/mL) | Correlation<br>Coefficient | n |
|-------------------------------------|-------|----------------------|----------------------------|----|
| Dade Behring<br>aca® NAPA test pack | 0.96 | -0.03 | 0.993 | 73 |

### Comments on Substantial Equivalence:

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

### Conclusion:

The Dade Behring Dimension® N-acety|procainamide (NAPA) Flex® reagent cartridge method and the predicate Dade Behring aca® NAPA analytical test pack method (K833378) 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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OCT 3 1 2003

+ boc 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: k032564

> Trade/Device Name: Dimension® N-acetylprocainamide (NAPA) Flex® reagent cartridge method Regulation Number: 21 CFR 862.3320 Regulation Name: Digoxin test system Regulatory Class: Class II Product Code: LAN 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) 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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Device Name:

Dimension® N-acetylprocainamide (NAPA) Flex® reagent cartridge method

Indications for Use:

The Dade Behring Dimension® N-acetylprocainamide (NAPA) Flex® reagent cartridge method is used to measure N-acetylprocainamide in serum or plasma. Measurements may be used in therapeutic drug monitoring to maintain adequate procainamide therapy.

Rm Naught

Richard M. Vaught Regulatory Affairs and Compliance Manager

August 19, 2003

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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**Office of In Vitro Diagnostic Device**
Evaluation and Safety

510(k) K03 2564

Prescription Use (Per 21 CFR 801.109)

OR

Over-the-counter Use

(Optional format 1-2-96)