The Dade Behring 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.

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.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study details:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Intended Use: For in vitro diagnostic use, quantitative determination of procainamide in serum or plasma. Measurements for diagnosis and treatment of procainamide overdose and therapeutic drug monitoring.	Intended Use: Matches the predicate device's intended use ("in vitro diagnostic use") and the stated purpose in the "Intended Use" section. Specific use cases (overdose, therapeutic monitoring) are also matched.
Assay Range: No specific numerical acceptance criteria stated for the new device as a direct pass/fail, but it performs within a specified range.	Assay Range: 0.5 - 20.0 ug/mL
Correlation with Predicate Device (aca® PROC analytical test pack): Demonstrated "good agreement (correlation)". No explicit numerical threshold for "good agreement" is given, but the results are presented.	Correlation Coefficient: 0.997 (indicating very strong positive correlation)
Slope (vs. predicate): Expected to be close to 1.0.	Slope: 1.03
Intercept (vs. predicate): Expected to be close to 0.0.	Intercept: -0.02 ug/mL

Note on Acceptance Criteria: The document describes acceptance criteria primarily through comparison to a legally marketed predicate device (Dade Behring aca® PROC analytical test pack). The acceptance criteria for the new device are implicitly met if its performance characteristics (Intended Use, Assay Range, and comparative performance data) are substantially equivalent to the predicate. The "good agreement (correlation)" is the primary measure for equivalence in this context.

Study Details

Sample Size used for the test set and the data provenance:
- Sample Size: 89 samples.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study is retrospective in the sense of comparing against an existing method, but the samples themselves could be prospective or retrospective clinical samples. The document refers to "split-sample comparative performance," which implies that 89 patient samples were divided and tested by both methods simultaneously.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not mentioned. For this type of in vitro diagnostic device (quantitative measurement of a drug level), the "ground truth" is typically the measurement by a comparative method (the predicate device in this case), not an expert consensus on a qualitative diagnosis.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/None. This is a quantitative assay comparison, not a diagnostic task where expert adjudication of images or clinical findings would be necessary. The comparison is directly between the numerical results of two different analytical methods.
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. This is not an AI/human reader study; it's a comparison of two in vitro diagnostic (IVD) systems for measuring drug concentration.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The Dimension® Procainamide (PROC) Flex® reagent cartridge method is an automated in vitro diagnostic test. Its performance data (Assay Range, correlation, slope, intercept) were generated by the device itself, without a human "reading" or interpreting the raw data in a way that would be analogous to a radiologist interpreting an image. The human element would be in operating the instrument and processing the samples, but the core measurement is algorithmic.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for evaluating the new device was the measurement obtained from the predicate device, the Dade Behring aca® PROC analytical test pack method. This is a common approach for new IVDs claiming substantial equivalence.
The sample size for the training set:
- Not specified. The document describes a performance evaluation study (test set), but does not explicitly mention a separate training set. For commercially available immunoassay kits, the "training" (calibration, optimization, etc.) is typically done during the product development and manufacturing phase, often on a larger, internal dataset, not usually detailed in 510(k) summaries for comparison studies.
How the ground truth for the training set was established:
- Not specified, as a training set is not explicitly mentioned in the context of this 510(k) summary. If one existed, it would likely involve established reference methods or highly characterized samples.

Summary

{0}------------------------------------------------

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® 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:

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:

{1}------------------------------------------------

	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	PETINIAturbidimetric rate340 nm and 700nm	EMIT®1colorimetric rate340 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:

ComparativeMethod	Slope	Intercept(ug/mL)	CorrelationCoefficient	n
Dade Behringaca® 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

{2}------------------------------------------------

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).

{3}------------------------------------------------

Page 2 -

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 (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 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

{4}------------------------------------------------

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)
✓

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

000004

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.