ROCHE DIAGNOSTICS ELECSYS PRECICONTROL TUMOR

K050387 · Roche Diagnostics Corp. · JJY · Apr 25, 2005 · Clinical Chemistry

Device Facts

• Record ID: K050387
• Device Name: ROCHE DIAGNOSTICS ELECSYS PRECICONTROL TUMOR
• Applicant: Roche Diagnostics Corp.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Apr 25, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Roche Diagnostics Elecsys PreciControl Tumor Marker is used for quality control of the Elecsys tumor marker immunoassays on the Elecsys immunoassay analyzers.

Device Story

PreciControl Tumor Marker is a lyophilized quality control material based on human serum. It is used in clinical laboratory settings to monitor the accuracy and precision of Elecsys immunoassay systems. The product contains analytes at two clinically relevant concentrations, including AFP, CEA, CA 15-3 II, CA 125 II, Ferritin, fPSA, tPSA, and CA 19-9. Laboratory technicians use the control by running it on the immunoassay analyzer; the resulting values are compared against expected ranges to verify system performance. This process ensures the reliability of patient test results generated by the immunoassay system.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Lyophilized human serum-based control material. Analyte concentrations provided for AFP, CEA, CA 15-3 II, CA 125 II, Ferritin, fPSA, tPSA, and CA 19-9. Stability: 2-8°C unopened, 2 weeks opened; 20-25°C on-analyzer up to 5 hours; -20°C for 1 month.

Indications for Use

Indicated for quality control of Elecsys tumor marker immunoassays on Elecsys immunoassay analyzers in clinical laboratory settings.

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

• Roche Diagnostics Elecsys PreciControl Tumor Marker (K972235)

Submission Summary (Full Text)

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K050387

## 510(k) Summary - Elecsys® PreciControl Tumor Marker

| 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 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter name, address, contact | Roche Diagnostics Corporation<br>9115 Hague Rd<br>Indianapolis IN 46250<br>[phone] |
| | Contact person: Kay A. Taylor |
| | Date prepared: February 14, 2005 |
| Device Name | Proprietary name: Roche Diagnostics Elecsys® PreciControl Tumor Marker |
| | Common name: Quality Control Material |
| | Classification name: Multi-analyte Controls (assayed and unassayed) |
| Device description | PreciControl Tumor Marker contains lyophilized control serum based on human serum. The concentrations are in two clinically relevant ranges. The controls are used for monitoring the accuracy and precision of Elecsys immunoassays. |
| Intended use | PreciControl Tumor Marker is used for quality control of Elecsys immunoassays on Elecsys immunoassay systems. |
| Predicate Device | We claim substantial equivalence to the currently marketed Elecsys® PreciControl Tumor Marker (K972235). |

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## 510(k) Summary - Elecsys® PreciControl Tumor Marker,

continued

The table below indicates the similarities between the modified Elecsys® Device Comparison PreciControl Tumor Marker and the current device.

| Topic | Elecsys® PreciControl Tumor<br>Marker<br>(K972235) | Elecsys® PreciControl Tumor<br>Marker<br>(Modified Device) |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | PreciControl Tumor Marker is used<br>for quality control of Elecsys<br>immunoassays using the Elecsys<br>immunoassay systems (Elecsys 2010,<br>1010 and others of the Elecsys family<br>of instruments). | PreciControl Tumor Marker is used<br>for quality control of Elecsys<br>immunoassays on Elecsys<br>immunoassay systems. |
| Analyzer<br>System | Elecsys® immunoassay analyzers | Same |
| Reagent<br>Format | lyophilized, based on human serum | Same |
| Analyte<br>Concentration<br>PC TM1 / PC<br>TM2 | AFP: approx. 8 & 100 IU/ml<br>CEA: approx. 5 & 50 ng/ml<br>CA 15-3 II: approx. 20 & 100 U/mL<br>CA 125 II: approx. 35 & 100 U/mL<br>Ferritin: approx. 25 & 200 ng/mL<br>fPSA: approx. 1 & 10 ng/mL<br>tPSA: approx. 4 & 40 ng/mL | AFP: approx. 8 & 100 IU/ml<br>CEA: approx. 5 & 50 ng/ml<br>CA 15-3 II: approx. 20 & 100 U/mL<br>CA 125 II: approx. 35 & 100 U/mL<br>Ferritin: approx. 25 & 200 ng/mL<br>fPSA: approx. 1 & 10 ng/mL<br>tPSA: approx. 4 & 40 ng/mL<br>CA 19-9: approx. 20 & 100 U/mL, |
| Stability | @ 2-8° C<br>• unopened until expiration date<br>• opened for 2 weeks<br>@ 20-25° C<br>• on the analyzers, up to 5<br>hours<br>• 24 hours<br>@ -20° C<br>• 1 month (freeze only once)<br>months at -20° C (only freeze once) | Same |

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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 consists of a stylized eagle with three lines representing its wings and tail feathers. The eagle is facing right and appears to be in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Public Health Service

APR 2 5 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Roche Diagnostics Corp. c/o Ms. Kay A. Taylor Regulatory Affairs Principal Centralized Diagnostics 9115 Hague Rd. Indianapolis, IN 46250

Re: k050387

Trade/Device Name: Elecsys PreciControl Tumor Marker Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I Product Code: JJY Dated: February 14, 2005 Received: February 15, 2005

Dear Ms. Taylor:

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 prover to the ready 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advisour that 227 » ination 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 Part 801); good manufacturing practice requirements as set forth in the quality labeling (21 CFR Part 800), and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Ms Kay A. Taylor

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 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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance 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/dsma/dsmamaif.html

Sincerely yours,

Lobert Becker/

Robert L. Becker, Jr., M.D., PhD Director Division of Immunology and Hematology Devices 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): Ko502

Device Name: Elecsys PreciControl Tumor Marker

Indications For Use:

PreciControl Tumor Marker is used for quality control of Elecsys immunoassays on Elecsys immunoassay systems.

The controls are used for monitoring the accuracy and precision of Elecsys immunoassays.

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

Over-The-Counter Use (21 CFR 807 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)

In chan

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k) K050287