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.

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.

AI/ML Overview

Below is a summary of the acceptance criteria and study information for the Roche ONLINE Quinidine Assay, based on the provided text.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct numerical targets in the provided text. However, the study aims to demonstrate substantial equivalence to a predicate device (Roche COBAS INTEGRA Quinidine Assay) and an Enzyme Immunoassay by showing comparable precision and method correlation. The reported device performance is presented in comparison to these predicate methods.

Performance Characteristic	Acceptance Criteria (Implied by Predicate)	Roche ONLINE TDM Quinidine Reported Performance
Method Comparison		Versus Roche COBAS INTEGRA Quinidine Assay
Correlation (R)	0.991 (Predicate)	0.991
Regression (Y=mX+b)	Y = 1.054X - 0.036 (Predicate)	Y = 1.054X - 0.036
Range	0.16 to 5.7 µg/mL (Predicate)	0.22 to 7.04 µg/mL
		Versus Enzyme Immunoassay
Correlation (R)	0.991 (Predicate)	0.991
Regression (Y=mX+b)	Y = 0.941X - 0.024 (Predicate)	Y = 0.941X - 0.024
Range	Not explicitly stated for EIAA	0.16 to 5.7 µg/mL
Precision (Level 1)
Mean (µg/mL)	1.35 (Predicate)	0.93
CV% (within run)	2.1 (Predicate)	2.0
CV% (total)	3.2 (Predicate)	3.9
Precision (Level 2)
Mean (µg/mL)	3.47 (Predicate)	2.87
CV% (within run)	2.2 (Predicate)	1.3
CV% (total)	3.5 (Predicate)	2.7
Precision (Level 3)
Mean (µg/mL)	5.42 (Predicate)	4.61
CV% (within run)	2.0 (Predicate)	1.2
CV% (total)	3.2 (Predicate)	2.7

2. Sample Size and Data Provenance for the Test Set

Sample Size (Method Comparison):
- N = 150 (for comparison against Roche COBAS INTEGRA Quinidine Assay)
- N = 154 (for comparison against Enzyme Immunoassay)
Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

3. Number of Experts and Qualifications for Ground Truth (Test Set)

This information is not applicable as the device is an in-vitro diagnostic assay for quinidine quantification, not an imaging or diagnostic AI with subjective interpretation requiring human experts for ground truth establishment. The performance is assessed against established laboratory methods.

4. Adjudication Method (Test Set)

This information is not applicable for the same reasons as point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not done. This type of study is relevant for devices involving human interpretation (e.g., radiologists reading images), which is not the case for this automated immunoassay.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance evaluation was done. The entire study focuses on the performance of the "Roche ONLINE TDM Quinidine" assay itself, in comparison to other existing assays. There is no mention of human-in-the-loop performance; the device is automated for quantitative determination.

7. Type of Ground Truth Used

The ground truth used for comparison was the results obtained from:

The Roche COBAS INTEGRA Quinidine Assay (predicate device).
An Enzyme Immunoassay.
The performance of these established methods served as the reference for determining the new device's accuracy and precision.

8. Sample Size for the Training Set

The provided text does not contain information regarding a specific training set or its sample size. This type of submission (510(k) for an in-vitro diagnostic) focuses on validation and comparison to a predicate, rather than the development and training of a machine learning model.

9. How the Ground Truth for the Training Set Was Established

Since there is no mention of a training set, the method for establishing its ground truth is not applicable from the provided text.

Summary

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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 (317) 845-2000 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

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.

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,(Predicate labeling)
Versus Roche COBAS INTEGRA QuindineAssay (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
NCCLSPrecision:	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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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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Roche Diagnostics Corporation

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

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

	Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)	OR	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

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.