ONLINE TDM PROCAINAMIDE

K060773 · Roche Diagnostics Corp. · LAR · Aug 23, 2006 · Clinical Toxicology

Device Facts

• Record ID: K060773
• Device Name: ONLINE TDM PROCAINAMIDE
• Applicant: Roche Diagnostics Corp.
• Product Code: LAR · Clinical Toxicology
• Decision Date: Aug 23, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3320
• Device Class: Class 2

Intended Use

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 ensure proper therapy.

Device Story

ONLINE TDM Procainamide is an in vitro diagnostic assay for quantitative measurement of procainamide in human serum or plasma. Used on Roche automated clinical chemistry analyzers (Hitachi 911, 912, 917, Modular P) in clinical laboratory settings. Operates via homogeneous enzyme immunoassay; competition between sample drug and G6PDH-labeled drug for antibody binding sites. Enzyme activity inversely proportional to drug concentration; active enzyme converts NAD to NADH, measured spectrophotometrically. Results assist clinicians in monitoring therapeutic levels and managing overdose. Benefits include automated, rapid quantification of drug levels to ensure appropriate patient dosing.

Clinical Evidence

No clinical studies performed. Evidence consists of analytical bench testing: precision (CV 1.5-9.3%), linearity (0.33–14 µg/mL), analytical specificity (no significant interference from common drugs or endogenous substances), and method comparison studies against predicate devices (n=51 and n=48 samples, r=0.9975 and r=0.997 respectively).

Technological Characteristics

Homogeneous enzyme immunoassay; competitive binding principle using bacterial (Leuconostoc mesenteroids) G6PDH enzyme. Measures absorbance change spectrophotometrically. Designed for use on Roche automated clinical chemistry analyzers (Hitachi 911, 912, 917, Modular P).

Indications for Use

Indicated for quantitative determination of procainamide in human serum or plasma for patients requiring monitoring of procainamide levels for therapy or diagnosis of overdose. Prescription use only.

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

• COBAS Integra Procainamide (k951595)

Reference Devices

• Preciset TDM II Calibrators (k031856)
• TDM Control Set (k060429)
• EMIT 2000 Procainamide (Roche/Hitachi 911)

Submission Summary (Full Text)

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

K 060773

# AUG 2 3 2006

# 510(k) Summary

.

| Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence. |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1) Submitter<br>name, address,<br>contact | Roche Diagnostics Corporation<br>9115 Hague Rd.<br>Indianapolis. IN 46250<br>[phone]<br>Contact Person: Dimitris Demirtzoglou |
| 2) Device name | Proprietary name: ONLINE TDM Procainamide<br>Common name: Enzyme Immunoassay, Procainamide<br>Classification name: Enzyme Immunoassay, Procainamide |
| 3) Predicate<br>device | We claim substantial equivalence to the currently marketed COBAS<br>INTEGRA Procainamide(K951595). |

Continued on next page

.

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

## 510(k) Summary, Continued

| 4) Device<br>Description | The ONLINE TDM Procainamide assay is for the quantitative determination<br>of procainamide in human serum or plasma on Roche automated clinical<br>chemistry analyzers. The proposed labeling indicates the Roche Hitachi 911,<br>912, 917 and Modular P analyzers can be used with the Roche ONLINE<br>TDM Procainamide reagent kits. |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The assay is based on a homogeneous enzyme immunoassay technique used<br>for the quantitative analysis of procainamide in human serum or plasma. The<br>assay is based on competition between drug in the sample and drug labeled<br>with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody<br>binding sites. Enzyme activity decreases upon binding to the antibody, so the<br>drug concentration in the sample can be measured in terms of enzyme<br>activity. Active enzyme converts oxidized nicotinamide adenine dinucleotide<br>(NAD) to NADH, resulting in an absorbance change that is measured<br>spectrophotometrically. Endogenous serum G6PDH does not interfere<br>because the coenzyme functions only with the bacterial (Leuconostoc<br>mesenteroids) enzyme employed in the assay. |
| 5.) Intended<br>Use | The ONLINE TDM Procainamide assay is for the quantitative determination<br>of procainamide in human serum or plasma on Roche automated clinical<br>chemistry analyzers.<br>Measurements are used in the diagnosis and treatment of procainamide<br>overdose and in monitoring levels of procainamide to ensure proper therapy. |
| | Continued on next page |

:

______________________________________________________________________________________________________________________________________________________________________________

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

### 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-<br>acetylprocainamide | | | Roche COBAS FP<br>Procainamide(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 |
| Method<br>Comparison | | Linear Regression: ONLINE TDM<br>Procainamide Vs. COBAS FP<br>Procainamide | | | Linear Regression: COBAS FP<br>Procainamide Vs. COBAS FARA II | | |
| | | N=51, Range = 0.3 -10.6 µg/ml<br>y = 1.01 x + 0.25<br>r = 0.998<br>SD (md 95) = 0.311 | | | N=156, Range = 0.13 - 16 µg/ml<br>y=0.944x +0.20<br>r=0.996 | | |

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

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).

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

#### 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 [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/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

{5}------------------------------------------------

### Indications for Use

510(k) Number (if known): k060773

Device Name: ONLINE TDM Procainamide

Indications For Use:

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.

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