The ONLINE TDM Procainamide assay is for the quantitative determination of procainamide in human serum or plasma on Roche automated clinical chemistry analyzers. Measurements are used in the diagnosis and treatment of procainamide overdose and in monitoring levels of procainamide to help ensure proper therapy.

Device Description

The ONLINE TDM Procainamide assay is for the quantitative determination of procainamide in human serum or plasma on Roche automated clinical chemistry analyzers. The proposed labeling indicates the Roche Hitachi 911, 912, 917 and Modular P analyzers can be used with the Roche ONLINE TDM Procainamide reagent kits.

The assay is based on a homogeneous enzyme immunoassay technique used for the quantitative analysis of procainamide in human serum or plasma. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the sample can be measured in terms of enzyme activity. Active enzyme converts oxidized nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that is measured spectrophotometrically. Endogenous serum G6PDH does not interfere because the coenzyme functions only with the bacterial (Leuconostoc mesenteroids) enzyme employed in the assay.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the ONLINE TDM Procainamide device:

Acceptance Criteria and Reported Device Performance

The device is evaluated for substantial equivalence to a predicate device (COBAS INTEGRA Procainamide, K951595). The acceptance criteria are implicitly defined by comparing the performance characteristics of the new device to the established performance of the predicate device, aiming for comparable or acceptable results. While specific numerical thresholds for "acceptable" are not explicitly stated, the context of substantial equivalence implies that the performance should be within a clinically acceptable range relative to the predicate.

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance (Roche ONLINE TDM N-acetylprocainamide)	Reported Predicate Performance (Roche COBAS FP Procainamide)
Precision	Comparable to predicate
Within-run
- Control 1 Mean	- Comparable	1.7 µg/ml	1.6 µg/ml
- Control 1 SD	- Comparable	0.03 µg/ml	0.05 µg/ml
- Control 1 CV%	- Comparable	1.5%	3.3%
- Control 2 Mean	- Comparable	7.1 µg/ml	6.1 µg/ml
- Control 2 SD	- Comparable	0.07 µg/ml	0.13 µg/ml
- Control 2 CV%	- Comparable	1.0%	2.1%
- Control 3 Mean	- Comparable	11.6 µg/ml	8.5 µg/ml
- Control 3 SD	- Comparable	0.28 µg/ml	0.21 µg/ml
- Control 3 CV%	- Comparable	2.4%	2.5%
Total
- Control 1 Mean	- Comparable	1.7 µg/ml	1.6 µg/ml
- Control 1 SD	- Comparable	0.04 µg/ml	0.05 µg/ml
- Control 1 CV%	- Comparable	2.6%	3.3%
- Control 2 Mean	- Comparable	7.1 µg/ml	6.1 µg/ml
- Control 2 SD	- Comparable	0.27 µg/ml	0.15 µg/ml
- Control 2 CV%	- Comparable	3.8%	2.4%
- Control 3 Mean	- Comparable	11.6 µg/ml	8.5 µg/ml
- Control 3 SD	- Comparable	1.08 µg/ml	0.22 µg/ml
- Control 3 CV%	- Comparable	9.3%	2.6%
Method Comparison	High correlation (r ≥ 0.99)	Linear Regression: y = 1.01x + 0.25, r = 0.998, SD (md 95) = 0.311	Linear Regression: y = 0.944x + 0.20, r = 0.996
		Range = 0.3 - 10.6 µg/ml	Range = 0.13 - 16 µg/ml
Lower Detection Limit	Acceptable results (compared to predicate)	(Specific value not provided, but stated as acceptable)	(Specific value not provided, but stated as acceptable)
Specificity	Acceptable results (compared to predicate)	(Details not provided, but stated as acceptable)	(Details not provided, but stated as acceptable)
Interfering Substances	Acceptable results (compared to predicate)	(Details not provided, but stated as acceptable)	(Details not provided, but stated as acceptable)

Study Details:

Sample sizes used for the test set and the data provenance:
- Precision Studies: The number of runs for the precision studies (within-run and total precision) is not explicitly stated, but the NCCLS guidelines typically involve a specific number of replicates over several days. The data provenance is not specified (e.g., country of origin), but it is a laboratory evaluation in the context of device development. It would be considered prospective for the device under evaluation.
- Method Comparison (ONLINE TDM Procainamide vs. COBAS FP Procainamide): N = 51 serum or plasma samples. Data provenance is not specified. Likely prospective laboratory evaluation.
- Method Comparison (COBAS FP Procainamide vs. COBAS FARA II): N = 156 samples. This is a comparison for the predicate device, not the new device directly, but demonstrates the predicate's performance. Data provenance is not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This device is an in-vitro diagnostic (IVD) for quantitative measurement of procainamide in human serum or plasma. The "ground truth" here is the actual concentration of procainamide. This is established by validated laboratory reference methods or by the predicate device itself, not typically by expert interpretation in the way a diagnostic imaging device would. Therefore, the concept of "experts" establishing ground truth in the traditional sense for image interpretation or pathology does not directly apply. The predicate device (COBAS INTEGRA Procainamide) served as the reference for comparison in the method comparison study.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable (N/A) for this type of IVD device. "Adjudication" refers to resolving disagreements among multiple human readers or experts, which is not relevant for quantitative chemical measurements.
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:
Not applicable (N/A). This is an IVD device for quantitative measurement, not an AI-assisted diagnostic imaging or interpretation system.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, this study represents a standalone performance evaluation of the ONLINE TDM Procainamide assay. The device itself is an automated clinical chemistry analyzer which quantitatively determines procainamide levels directly from samples. There isn't a human-in-the-loop component in the measurement process, though a human still interprets the results in the clinical context.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the new device's performance was established by comparison to a legally marketed predicate device (Roche COBAS INTEGRA Procainamide, K951595), which itself is presumed to have undergone rigorous validation against established analytical methods. For method comparison, the values obtained from the predicate device served as the reference for linearity and correlation. For precision, the "true" mean values for controls are set during their manufacturing and quality control.
The sample size for the training set:
Not applicable (N/A). This device is based on a homogeneous enzyme immunoassay technique, not a machine learning or AI algorithm that requires a "training set." It's a chemical assay.
How the ground truth for the training set was established:
Not applicable (N/A), as there is no "training set" in the context of an enzyme immunoassay.

Summary

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K 060773

AUG 2 3 2006

510(k) Summary

Introduction	According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence.
1) Submittername, address,contact	Roche Diagnostics Corporation9115 Hague Rd.Indianapolis. IN 46250(317) 521-7688Contact Person: Dimitris Demirtzoglou
2) Device name	Proprietary name: ONLINE TDM ProcainamideCommon name: Enzyme Immunoassay, ProcainamideClassification name: Enzyme Immunoassay, Procainamide
3) Predicatedevice	We claim substantial equivalence to the currently marketed COBASINTEGRA Procainamide(K951595).

Continued on next page

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510(k) Summary, Continued

4) DeviceDescription	The ONLINE TDM Procainamide assay is for the quantitative determinationof procainamide in human serum or plasma on Roche automated clinicalchemistry analyzers. The proposed labeling indicates the Roche Hitachi 911,912, 917 and Modular P analyzers can be used with the Roche ONLINETDM Procainamide reagent kits.
	The assay is based on a homogeneous enzyme immunoassay technique usedfor the quantitative analysis of procainamide in human serum or plasma. Theassay is based on competition between drug in the sample and drug labeledwith the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibodybinding sites. Enzyme activity decreases upon binding to the antibody, so thedrug concentration in the sample can be measured in terms of enzymeactivity. Active enzyme converts oxidized nicotinamide adenine dinucleotide(NAD) to NADH, resulting in an absorbance change that is measuredspectrophotometrically. Endogenous serum G6PDH does not interferebecause the coenzyme functions only with the bacterial (Leuconostocmesenteroids) enzyme employed in the assay.
5.) IntendedUse	The ONLINE TDM Procainamide assay is for the quantitative determinationof procainamide in human serum or plasma on Roche automated clinicalchemistry analyzers.Measurements are used in the diagnosis and treatment of procainamideoverdose and in monitoring levels of procainamide to ensure proper therapy.
	Continued on next page

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510(k) Summary, Continued

6.) Comparison The Roche ONLINE TDM Procainamide assay is substantially equivalent to to the Predicate other products in commercial distribution intended for similar use. Most Device notably, it is substantially equivalent to the currently marketed Roche COBAS INTEGRA Procainamide (K951595).

The Roche ONLINE TDM Procainamide assay was evaluated for several performance characteristics including precision, lower detection limit, method comparison, specificity, and interfering substances. All of the evaluation studies gave acceptableresults compared to the predicate device. These experiments provide evidence that the Roche ONLINE TDM Procainamide assay is substantially equivalent to the currently marketed Roche COBAS INTEGRA Procainamideassay. The following table summarizes the precision and method comparison results.

	Roche ONLINE TDM N-acetylprocainamide			Roche COBAS FPProcainamide(Predicate)
NCCLS Precision,	Control 1	Control 2	Control 3	Control 1	Control 2	Control 3
Within run
Mean (µg/ml)	1.7	7.1	11.6	1.6	6.1	8.5
SD (µg/ml)	0.03	0.07	0.28	0.05	0.13	0.21
CV%	1.5	1.0	2.4	3.3	2.1	2.5
NCCLS Precision,	Control 1	Control 2	Control 3	Control 1	Control 2	Control 3
Total
Mean (µg/ml)	1.7	7.1	11.6	1.6	6.1	8.5
SD (µg/ml)	0.04	0.27	1.08	0.05	0.15	0.22
CV%	2.6	3.8	9.3	3.3	2.4	2.6
MethodComparison	Linear Regression: ONLINE TDMProcainamide Vs. COBAS FPProcainamide			Linear Regression: COBAS FPProcainamide Vs. COBAS FARA II
	N=51, Range = 0.3 -10.6 µg/mly = 1.01 x + 0.25r = 0.998SD (md 95) = 0.311			N=156, Range = 0.13 - 16 µg/mly=0.944x +0.20r=0.996

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Public Health Service

AUG 23 2006

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Dimitris Demirtzoglou Regulatory Affairs Consultant Roche Diagnostics Corp. 9115 Hague Rd. Indianapolis, In 46250

Re: K060773

Trade/Device Name: ONLINE TDM Procainamide Regulation Number: 21 CFR 862.3320 Regulation Name: Digoxin test system Regulatory Class: Class II Product Code: LAR Dated: July 27, 2006 Received: July 28, 2006

Dear Mr. Demirtzoglou:

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 (240) 276-0484. 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/industry/support/index.html.

Sincerely yours.

Alberto G. A.

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K060773

Device Name: ONLINE TDM Procainamide

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division S

Page 1 of

Office of In Vitro Diagnostic Device Evelur tion and Safery

KD60773

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.