TDM CONTROL SET, MODEL CAT# 04521536

K070200 · Roche Diagnostics Corp. · JJY · Mar 19, 2007 · Clinical Chemistry

Device Facts

• Record ID: K070200
• Device Name: TDM CONTROL SET, MODEL CAT# 04521536
• Applicant: Roche Diagnostics Corp.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Mar 19, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The TDM Control Set is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheet.

Device Story

TDM Control Set is a liquid quality control material based on human serum containing 17 therapeutic drugs, preservatives, and stabilizers. It is used in clinical laboratory settings on Roche/Hitachi and COBAS INTEGRA analyzers to monitor the accuracy and precision of quantitative assays. The device provides three levels for each drug and two levels for serum barbiturates. The barbiturate assay utilizes the cross-reactivity of phenobarbital already present in the control to assign target values. Healthcare providers use the control results to verify that the analyzer's performance remains within specified ranges, ensuring the reliability of patient therapeutic drug monitoring results.

Clinical Evidence

Bench testing only; design control activities and risk analysis performed to validate the modification of adding serum barbiturates to the analyte list.

Technological Characteristics

Liquid control based on human serum with added therapeutic drugs, preservatives, and stabilizers. Provides three levels for 17 drugs and two levels for serum barbiturates. Analyte concentrations are lot-specific and provided in an accompanying value sheet. Designed for use on Roche/Hitachi and COBAS INTEGRA clinical chemistry analyzers.

Indications for Use

Indicated for use as an assayed quality control product on Roche/Hitachi and COBAS INTEGRA analyzers to monitor accuracy and precision for 17 therapeutic drugs (acetaminophen, amikacin, carbamazepine, digoxin, gentamicin, lidocaine, N-acetylprocainamide, phenobarbital, phenytoin, primidone, procainamide, quinidine, salicylate, theophylline, tobramycin, valproic acid, vancomycin) and serum barbiturates.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• TDM Control Set (K060429)

Submission Summary (Full Text)

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

K070200

| 510(k) Summary | MAR 19 2007 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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<br>9115 Hague Rd.<br>Indianapolis, IN 46250<br>[phone] |
| | Contact Person: Dimitris Demirtzoglou |
| | Date Prepared: January 19, 2007 |
| 2) Device name | Proprietary name: TDM Control Set |
| | Common name: Quality control material (assayed and unassayed). |
| | Classification name: Multi-analyte controls, all kinds (assayed and unassayed) |
| 3) Predicate devices | We claim substantial equivalence to the currently marketed TDM Control Set (K060429). |
| 4) Device Description | The TDM Control Set contains liquid controls based on human serum with added therapeutic drugs, preservative, and stabilizer. The adjusted concentrations and activities of the control components are usually in the normal range or at the normal/pathological threshold. Some of the methods as specified in the enclosed value sheet may not be available in all countries. |
| | The TDM Control Set contains a mixture of 17 different drugs. Drugs included are acetaminophen, amikacin, carbamazepine, digoxin, gentamicin, lidocaine, N-acetylprocainamide, phenobarbital, phenytoin, primidone, procainamide, quinidine, salicylate, theophylline, tobramycin, valproic acid and vancomycin |
| | The concentrations and activities of the components are lot-specific.<br>The exact values are given in the enclosed value sheet. |

.

Continued on next page

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

## 510(k) Summary, Continued ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| 5.) Intended<br>Use | The TDM Control Set is for use in quality control by monitoring accuracy and<br>precision for the quantitative methods as specified in the value sheet. |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6.) Comparison<br>to the Predicate<br>Device | Below the similarities and differences between the modified TDM Control<br>Set and its predicate device [TDM Control Set (K060429)] are presented. The<br>device will continue to be sold under the same name, TDM Control Set. |
| | The TDM Control Set contains liquid controls based on human serum with<br>added therapeutic drugs, preservative, and stabilizer. The TDM Control Set<br>contains a mixture of 17 different drugs. Drugs included are acetaminophen,<br>amikacin, carbamazepine, digoxin, gentamicin, lidocaine, N-acetylprocainamide, phenobarbital, phenytoin, primidone, procainamide,<br>quinidine, salicylate, theophylline, tobramycin, valproic acid<br>and<br>vancomycin.<br>The control set contains three levels for each drug. In addition, the TDM<br>Control Set is value assigned for two levels (level I & II) of serum<br>barbiturates, utilizing phenobarbital already present in the controls. |
| | The predicate device, TDM Control Set (K060429) is identical with the<br>current TDM Control set except that it is not value assigned fo two levels of<br>serum barbiturates. |
| | No new analytes were added, and no drug levels have changed. Therefore,<br>stability and composition have not changed. The package insert and intended<br>use have not changed, but the value assignment for serum barbiturates was<br>added to the value sheet. The traceability of the controls has not changed,<br>except of course for the serum barbiturates assignment. |
| | Here is a summary of the TDM Control Set in relation to serum barbiturates: |
| | The TDM Control Set contains phenobarbital. The controls were tested using<br>the Serum Barbiturates assay. The Serum Barbiturates assay is calibrated<br>with secobarbital, with cross-reactivity to phenobarbital of approximately<br>26%. Essentially, we are using the cross-reactivity of the phenobarbital in the<br>controls to allow us to assign targets for the Serum Barbiturates assay. |

:

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

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, rendered in black. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle, also in black. The text is in all capital letters.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Roche Diagnostics Corp. 9115 Hague Road, PO Box 50416 Indianapolis, IN 46250-0457 ATTN: Mr. Dimitris Demirtzoglou MAR 1 9 2007

Re: k070200 Trade/Device Name: TDM Control Set Regulation Number: 21 CFR \$862.1660 Regulation Name: Quality control material (assayed and unassayed). Regulatory Class: Class I (reserved) Product Code: JJY Dated: March 06, 2007 Received: March 07, 2007

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).

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

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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean m. Cooper, M.S., D.V.M.

Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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

## Indications for Use

510(k) Number (if known):

Device Name: TDM Control Set

Indications For Use:

The TDM Control Set is intended for use as an assayed quality control product on Roche/Hitachi and COBAS INTEGRA analyzers. Two assayed levels of serum barbiturates and three assayed levels of acetaminophen, amikacin, carbamazepine, digoxin, gentamicin, lidocaine, N-acety/procainamide, phenobarbital, phenytoin, primidone, procainamide, quinidine, salicylate, theophylline, tobramycin, valproic acid and vancomycin are provided.

Prescription Use x (Part 21 CFR 801 Subpart D)

5100

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 Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of