The Dade Behring 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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Dade Behring Dimension® N-acetylprocainamide (NAPA) Flex® reagent cartridge method:

Summary of Acceptance Criteria and Device Performance:

The document describes a comparative study to demonstrate substantial equivalence to a predicate device, the Dade Behring aca® NAPA analytical test pack (K833378). The primary acceptance criteria appear to be related to the correlation and agreement between the new device and the predicate device.

Acceptance Criteria Category	Specific Metric	Predicate Device Performance / Acceptance Threshold (Implied)	Device Performance (Dimension® NAPA Flex®)
Intended Use	Same as predicate	in vitro diagnostic use	in vitro diagnostic use
Assay Range	Comparable to predicate, potentially broader	1.0 - 16.0 ug/mL	0.5 - 30.0 ug/mL
Measurement Method	Homogenous immunoassay	EMIT® colorimetric rate 340 nm	PETINIA turbidimetric rate 340 nm and 700nm
Correlation with Predicate	Correlation Coefficient	High correlation (implied > 0.95 or similar)	0.993
Agreement with Predicate	Slope	Close to 1.0 (implied)	0.96
Agreement with Predicate	Intercept	Close to 0.0 ug/mL (implied)	-0.03 ug/mL

Study Information:

Sample size used for the test set and the data provenance:
- Sample Size: 73 samples (n=73) were used for the comparative study between the Dimension® NAPA Flex® method and the predicate aca® NAPA method.
- Data Provenance: The document does not specify the country of origin. It indicates the study was a "split-sample comparative performance" evaluation, meaning each sample was tested by both methods. It is a retrospective or prospective study from a practical perspective, as 73 samples obtained from patients (human source) would be retrospectively analyzed by both new and predicate methods.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of immunoassay study typically does not rely on "experts" to establish a ground truth in the traditional sense (e.g., radiologists interpreting images). Instead, the "ground truth" or reference is the performance of the predicate device, which is an already legally marketed and accepted method for NAPA quantification. No independent experts were involved in establishing the ground truth for the individual sample concentrations.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- No adjudication method was used or needed. The comparison was directly between the quantitative results of the new device and the predicate device.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This is a clinical chemistry immunoassay device, not an imaging device that would involve human readers or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the performance presented for the "Dimension® NAPA Flex® reagent cartridge method" is inherently a standalone performance (algorithm/assay only) without human-in-the-loop interaction beyond the standard operation of the clinical chemistry system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in this context is the results obtained from the legally marketed predicate device (Dade Behring aca® NAPA analytical test pack). The study's purpose was to demonstrate substantial equivalence by showing good agreement with this established method.
The sample size for the training set:
- The document does not explicitly mention a "training set" for an algorithm. For an immunoassay, the development process involves reagent formulation, assay optimization, and calibration. The presented study data (n=73) would be considered part of the validation/test set used for regulatory submission.
How the ground truth for the training set was established:
- As there's no mention of a traditional "training set" for an algorithm in the context of this immunoassay, the establishment of ground truth for such a set is not applicable. The assay itself is developed and optimized against known standards and controls, not a large "training set" of patient samples for machine learning.

Summary

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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. VaughtDade Behring Inc.P.O. Box 6101Newark, DE 19714-6101
Date of Preparation:	August 19, 2003
Name of Product:	Dimension® N-acetylprocainamide (NAPA) Flex® reagent cartridgemethod
FDA Classification Name:	N-acetylprocainamide test system (21CFR§862.3320; 91LAR)
Predicate Device:	Dade Behring aca® NAPA analytical test pack (K833378)

Device Description:

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:

ComparativeMethod	Slope	Intercept(ug/mL)	CorrelationCoefficient	n
Dade Behringaca® 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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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three curved lines representing its body and wings. The bird is facing left. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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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Page 2 -

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 (301) 594-3084. 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 (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 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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division Sign-Off

Office of In Vitro Diagnostic Device
Evaluation and Safety

510(k) K03 2564

Prescription Use (Per 21 CFR 801.109)

Over-the-counter Use

(Optional format 1-2-96)

Regulation Number and Section

§ 862.3320 Digoxin test system.

(a)
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.(b)
Classification. Class II.