LIQUICHEK TUMOR MARKER CONTROL

K071675 · Bio-Rad Laboratories · JJY · Jul 3, 2007 · Clinical Chemistry

Device Facts

• Record ID: K071675
• Device Name: LIQUICHEK TUMOR MARKER CONTROL
• Applicant: Bio-Rad Laboratories
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jul 3, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Liquichek Tumor Markers Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Device Story

Liquichek Tumor Markers Control is an assayed quality control material used in clinical laboratories to monitor the precision of testing procedures for various tumor marker analytes. The device is a liquid-form control containing human and animal serum albumin and preservatives. It is provided in three levels (Level 1, 2, and 3) and is stored frozen (-20°C to -70°C). Laboratory technicians use the control to verify the performance of diagnostic assays; results are compared against expected values provided in the package insert to ensure analytical precision. By monitoring these controls, laboratories can identify potential errors in testing procedures, thereby ensuring the reliability of patient test results.

Clinical Evidence

No clinical data. Bench testing only. Stability studies confirmed open-vial stability of 30 days at 2°C to 8°C (15 days for IGF-1) and a two-year shelf life. Value assignments are derived from replicate analysis using FDA-cleared/approved tests.

Technological Characteristics

Ready-to-use liquid control material. Matrix consists of human and animal serum albumin, chemicals, stabilizers, and preservatives (concentration ≤0.1%). Analytes include AFP, B2-M, CA 15-3, CA 19-9, CA 27-29, CA 125, CEA, Ferritin, hCG, IGF-1, PAP, Prolactin, PSA, Free PSA, and Thyroglobulin. Storage at -20°C to -70°C. No specific software or electronic connectivity.

Indications for Use

Indicated for use as an assayed quality control material to monitor the precision of laboratory testing procedures for specific tumor marker analytes in clinical 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

• Lyphochek Tumor Markers Control (K011579)

Submission Summary (Full Text)

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## Bio-Rad Laboratories Liquichek Tumor Markers Control Premarket Notification Section 510(k)

### 1.0 DEVICE INFORMATION

| Product Name: | Liquichek Tumor Markers Control |
|---------------|-------------------------------------------------------------------------------------|
| Common Name: | Clinical Chemistry Test Systems<br>Quality control material (assayed and unassayed) |

## 2.0 MEDICAL DEVICE ESTABLISHMENT

| Manufacturing Facility: | Bio-Rad Laboratories |
|-------------------------|------------------------------------------------|
| Address: | 9500 Jeronimo Road<br>Irvine, California 92618 |
| Telephone: | 949-598-1200 |
| Fax: | 949-598-1557 |

Establishment Registration No .: 2016706

### 3.0 DEVICE CLASS

| Classification: | Class I |
|--------------------|-----------------|
| Product Code: | JJY |
| Regulation Number: | 21 CFR 862.1660 |

## 4.0 PERFORMANCE STANDARDS

None Require

## 5.0 PROPOSED LABELING

Included in this 510(k) notification is a copy of the proposed Liquichek Tumor Markers Control vial, box and insert labels (Appendices 3, 4 and 5).

### 6.0 Statement of Substantial Equivalence

Liquichek Turnor Markers Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. This control is substantially equivalent to the following quality control material that is currently in the market:

Lyphochek Tumor Markers Control Bio-Rad Laboratories Irvine, California 92618

510 (k) Number: K011579

A copy of the product insert for the above product can be found in Appendix 7.

JUL 3 1 2007

⁰²_510(k) Liq Tumor Markers_547 07/07 - Rev. 7/25/07

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## Comparison of the new device with the Predicate Device 7.0

Liquichek Tumor Markers Control claims substantial equivalence to the Lyphochek Tumor Markers Control currently in commercial distribution (K011579).

| Table 1. Similarities and Differences between new and predicate device. | | |
|-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | Bio-Rad Laboratories<br>Liquichek Tumor Markers Control<br>(New Device) | Bio-Rad Laboratories<br>Lyphochek Tumor Markers Control<br>(Predicate Device (K011579) |
| | Similarities | |
| Intended Use | Liquichek Tumor Markers Control is intended for use as an<br>assayed quality control material to monitor the precision of<br>laboratory testing procedures for the analytes listed in the<br>package insert. | Lyphochek Tumor Markers Control is intended for use as an<br>assayed quality control material to monitor the precision of<br>laboratory testing procedures for the analytes listed in the package<br>insert. |
| | Differences | |
| Form | Liquid | Lyophilized |
| Matrix | Human and animal serum albumin | Human serum |
| Levels | Level 1, 2 and 3 | Level 1 and 2 |
| Preservatives | Contains preservatives | Does not contains preservatives |
| Storage (Unopened) | -20°C to -70°C.<br>Until expiration date | 2°C to 8°C<br>Until expiration date |
| Open Vial Claim /<br>After reconstitution | All analytes 30 days at 2 to 8°C,<br>Exceptions:<br>• Insulin-like Growth Factor-I (IGF-1) 15 days. | All analytes 14 days at 2 to 8°C<br>Exceptions:<br>• Ferritin and CA 27-29 6 days.<br>• ACTH, Free PSA, PSA, Calcitonin assay immediately. |
| After reconstituting<br>and freezing | No claims | 30 days at -10 to -20°C. |
| Analytes | Contains claim for the following:<br>• Alpha Fetoprotein<br>• Beta-2-Microglobulin<br>• CA 15-3<br>• CA 19-9<br>• CA 27.29<br>• CA 125<br>• CEA<br>• Ferritin<br>• hCG (β-hCG, Total hCG, Intact hCG)<br><br>Does not contain claim for the following:<br>• Aldosterone<br>• ACTH<br>• CA 50<br>• CASA<br>• Neuron Specific Enolase | Contains claim for the following:<br>• Alpha Fetoprotein<br>• Beta-2-Microglobulin<br>• CA 15-3<br>• CA 19-9<br>• CA 27-29<br>• CA 72-4<br>• CA 125<br>• CEA<br>• CYFRA 21-1<br>• Ferritin<br>• hCG hCG – Beta Subunit<br><br>Does not contain claim for the following:<br>• Thyroglobulin<br>• Insulin-like Growth Factor-I |

## Table 1. Similarities and Differences between new and predicate device

## Statement of Supporting Data 8.0

Stability studies have been performed to determine the open vial stability and shelf life for this control. Product claims are as follows:

- Open vial Stability: All analytes will be stable for 30 days at 2 to 8℃, with the . following exception: Insulin-like Growth Factor-I (IGF-1) will be stable for 15 days.
- . Shelf Life: 2 Years at -20°C to -70°C

All supporting data is retained on file at Bio-Rad Laboratories.

## CONFIDENTIAL

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# Attachment 2

# Liquichek Tumor Markers Control Summary of Safety and Effectiveness

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Image /page/3/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 wavy lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Bio-Rad Laboratories c/o Ms. Maria Zeballos Regulatory Affairs Specialist 9500 Jeronimo Rd. Irvine, CA 92618-2017

JUL 3 1 2007

Re: k071675

Trade/Device Name: Liquichek Tumor Markers Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: June 15, 2007 Received: June 19, 2007

Dear Ms. Zeballos:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice 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

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Page 2 –

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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.

Robert M. Beckerf

Robert L. Becker, Jr., M.D., Ph.D 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):

Ko71675

Device Name:

Liquichek Tumor Markers Control

Indications For Use:

Liquichek Tumor Markers Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Prescription Use (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)

Maria Inchan

**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Safety

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510k)