FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20

K101809 · Fujirebio Diagnostics,Inc. · JJY · Oct 5, 2010 · Clinical Chemistry

Device Facts

• Record ID: K101809
• Device Name: FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20
• Applicant: Fujirebio Diagnostics,Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Oct 5, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

For In Vitro Diagnostic Use Only. Fujirebio Diagnostics Tumor Marker Control is intended for use as an assayed control serum to monitor the precision of laboratory testing procedures for the analysis of AFP, CA15-3, CA19-9, CA125, CEA, Ferritin, HE4, PSA and Free PSA.

Device Story

Fujirebio Diagnostics Tumor Marker Control is a lyophilized, human serum-based quality control material used in clinical and hospital laboratories. It serves as an objective tool for laboratory personnel to monitor the precision of testing procedures for specific tumor markers (AFP, CA15-3, CA19-9, CA125, CEA, Ferritin, HE4, PSA, and Free PSA). The device is provided in two levels to compare observations against expected ranges, ensuring consistent performance of testing systems. Healthcare providers use the output to verify the accuracy and precision of their laboratory assays, thereby supporting reliable clinical decision-making regarding patient tumor marker levels. The control is reconstituted by the user and is stable for specified durations at 2-8°C or <-20°C.

Clinical Evidence

No clinical data. Bench testing only. Stability studies were conducted to establish shelf-life (18 months unopened at 2-8°C) and reconstituted stability (14 days at 2-8°C for most analytes, 7 days for Free PSA; 60 days at <-20°C).

Technological Characteristics

Lyophilized human serum matrix. Two levels of control. Reconstitution volume 3.0 mL. Stability: 18 months unopened at 2-8°C; 14 days reconstituted at 2-8°C (except Free PSA at 7 days); 60 days reconstituted at <-20°C. Compatible with repeated freeze/thaw cycles (up to 9 cycles).

Indications for Use

Indicated for use as an assayed control serum in clinical and hospital laboratories to monitor the precision of laboratory testing procedures for tumor marker analytes (AFP, CA15-3, CA19-9, CA125, CEA, Ferritin, HE4, PSA, and Free PSA).

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

• Bio-Rad Lyphochek® Tumor Marker Plus Control (K082036)
• ARCHITECT HE4 Control Kit (K093957)

Submission Summary (Full Text)

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# 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K101809

# Submitter Information

OCT - 5 2010

| Address: | |
|----------|--|
|----------|--|

| Address: | Fujirebio Diagnostics, Inc.<br>201 Great Valley Parkway<br>Malvern, PA 19355 |
|---------------------------|------------------------------------------------------------------------------|
| Contact person: | Stacey Dolan<br>[phone]<br>[e-mail] |
| Summary preparation date: | October 5, 2010 |

**Name of Device**

| Trade/Proprietary Name: | Fujirebio Diagnostics Tumor Marker Control |
|-------------------------|---------------------------------------------------|
| Common/Usual Name: | Quality control material (assayed and unassayed). |
| Regulation Number: | 21 CFR 862.1660 |
| Regulatory Class: | Class I, reserved |
| Product Code: | JJY |

Fujirebio Diagnostics, Inc.

# Predicate Device

Bio-Rad Lyphochek® Tumor Marker Plus Control (K082036) For HE4: ARCHITECT HE4 Control Kit (K093957)

# Summary and Principle

This quality control product can be used as an objective judgment of the laboratory's procedures and personnel techniques. It is a valuable tool to assess good laboratory practices. Two levels of control are available to compare observations with expected ranges therefore assuring consistent performance of the testing systems within the clinical range.

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#### Intended Use

For In Vitro Diagnostic Use Only.

Fujirebio Diagnostics Tumor Marker Control is intended for use as an assayed control serum to monitor the precision of laboratory testing procedures for the analysis of AFP, CA15-3, CA19-9, CA125, CEA, Ferritin, HE4, PSA and Free PSA.

#### Statement of Substantial Equivalence

The Fujirebio Diagnostics Tumor Marker Control is intended for use as a quantitative, assayed control serum to monitor the procedures used in the laboratory for testing the analytes listed in the lot specific assigned values sheet.

The Fujirebio Diagnostics Tumor Marker Control is substantially equivalent to the Lyphochek Tumor Marker Plus Control*. Each of the devices are assayed quality control material and are used to monitor the precision of laboratory testing procedures for the analytes listed in their respective package insert.

*Note: For HE4, the Fujirebio Diagnostics Tumor Marker Control is substantially equivalent to the ARCHITECT HE4 Control Kit.

The regulatory submission is prepared pursuant to Title 21CFR § 862.1660.

A comparison of the features of the Fujirebio Diagnostics Tumor Marker Control and the Predicate Device are as follows:

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| Similarities | | |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Fujirebio Diagnostics Tumor<br>Marker Control<br>(Proposed Device)<br>K101809 | Bio-Rad Lyphochek® Tumor<br>Marker Plus Control<br>(Predicate Device)<br>K082036<br>For HE4:<br>ARCHITECT HE4 Control Kit<br>K093957 |
| Device Type | In vitro diagnostic | In vitro diagnostic |
| Classification | Class I, reserved | Class I, reserved |
| CFR section | 862.1660 | 862.1660 |
| Product Code | JJY | JJY |
| Product Usage | Clinical and Hospital laboratories | Clinical and Hospital laboratories |
| Intended Use | For In Vitro Diagnostic Use Only.<br>Fujirebio Diagnostics Tumor<br>Marker Control is intended for use<br>as an assayed control serum to<br>monitor the precision of laboratory<br>testing procedures for the analysis<br>of AFP, CA15-3, CA19-9, CA125,<br>CEA, Ferritin, HE4, PSA and Free<br>PSA. | Lyphochek Tumor Marker Plus<br>Control is intended for use as an<br>assayed quality control serum to<br>monitor the precision of laboratory<br>testing procedures for the analytes<br>listed in the package insert.<br>The ARCHITECT HE4 Controls<br>are used for the verification of the<br>accuracy and precision of the<br>ARCHITECT i System when used<br>for the quantitative determination<br>of HE4 antigen in human serum. |
| Matrix | Human Serum | Human Serum<br>(For HE4, matrix is protein buffer) |
| Form | Lyophilized | Lyophilized<br>(For HE4, Liquid) |
| Analytes | AFP, CA 15-3, CA 19-9, CA 125,<br>CEA, Ferritin, PSA, Free PSA | AFP, CA 15-3, CA 19-9, CA 125,<br>CEA, Ferritin, PSA, Free PSA |
| Stability - Reconstituted<br>at 2-8°C | 14 days at 2-8°C, except Free PSA<br>which is stable for 7 days | 14 days at 2-8°C, except Free PSA<br>which is stable for 7 days |

3 .

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Premarket Notification (510(k)) Tumor Marker Control

Image /page/3/Picture/1 description: The image contains the logo for "FUJIREBIO Diagnostics, Inc.". The logo consists of a stylized graphic on the left and the company name on the right. The graphic is composed of overlapping shapes, while the company name is written in a simple, sans-serif font.

| Differences | | |
|----------------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| | Fujirebio Diagnostics Tumor<br>Marker Control<br>(Proposed Device)<br>K101809 | Bio-Rad Lyphochek® Tumor<br>Marker Plus Control<br>(Predicate Device)<br>K082036<br><br>For HE4:<br>ARCHITECT HE4 Control Kit<br>K093957 |
| Number of Levels | 2 | 3 |
| PSA Stability<br>(reconstituted) | Total PSA - 14 days<br>Free PSA - 7 days | Total PSA – 7 days<br>Free PSA - 7 days |
| Reconstitution Volume | 3.0 mLs | 2.0 mLs |
| Analytes | HE4 (Human Epididymis Protein 4) | ACTH, Aldosterone, Beta-2-<br>Microglobulin, CA 27.29,<br>Calcitonin, hCG, Prolactin,<br>Prostatic Acid Phosphatase, and<br>Thyroglobulin |
| Stability (unopened) | 18 months at 2-8°C | 3 years at 2-8°C<br>(For HE4, 9 Months) |
| Stability - Reconstituted<br>at 2-8°C | CEA and Total PSA 14 days at<br>2-8°C | CEA 11 days at 2-8°C<br>Total PSA 7 days at 2-8°C |
| Stability - Reconstituted<br>at <-20°C | All analytes are stable for 60 days<br>when stored at <-20°C | All analytes are stable for 30 days<br>when stored at <-20°C |
| Stability - Freeze/thaw | May be frozen and thawed<br>repeatedly for up to 9 cycles | No claim made for freeze/thaw<br>stability |
| Endogenous (Non-<br>Spiked) analytes | CA 242 and CA 27.29* | None |

r

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/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 wings, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is in black and white.

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

Fujirebio Diagnostics, AB c/o Ms. Christina Hall Director, Quality and Regulatory Affairs Majnabbe Terminal Gothenburg, Sweden, SE 41455, SW

OCT 05 2010

Re: k101809

Trade/Device Name: Fujirebio Diagnostics Tumor Marker Controls Regulation Number: 21 CFR8862.1660 Regulation Name: Quality Control Material, Assayed and Unassayed Regulatory Class: Class I (Reserved) Product Code: JJY Dated: September 3, 2010 Received: September 9, 2010

Dear Ms. Hall:

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 class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice

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Page 2 - Ms. Christina Hall

requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Maria M. Chan, Ph.D.

tow 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 Form

510(k) Number (if known): K101809

Device Name: Fujirebio Diagnostics Tumor Marker Controls

QCT - 5 2010

Indications for Use:

For In Vitro Diagnostic Use Only.

Fujirebio Diagnostics Tumor Marker Control is intended for use as an assayed control serum to monitor the precision of laboratory testing procedures for the analysis of AFP, CA15-3, CA19-9, CA125, CEA, Ferritin, HE4, PSA and Free PSA.

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 OF NEEDED)

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

Keene Philip

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k101809

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