LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580

K011579 · Bio-Rad · JJY · Jun 26, 2001 · Clinical Chemistry

Device Facts

• Record ID: K011579
• Device Name: LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580
• Applicant: Bio-Rad
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jun 26, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Lyphochek® Tumor Marker Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for analytes listed in this package insert.

Device Story

Lyphochek® Tumor Marker Control is a human serum-based, lyophilized quality control product. It is used by laboratory personnel to monitor the precision of testing procedures for various tumor marker analytes. The control is reconstituted by the user and analyzed alongside patient samples. By comparing the observed results of the control against established target values, clinicians assess the performance and reliability of their laboratory assays. This monitoring helps ensure the accuracy of clinical diagnostic testing, ultimately supporting reliable patient diagnosis and management.

Clinical Evidence

Bench testing only. Stability studies were conducted to determine open-vial stability and shelf life. Results demonstrated 14-day stability for most analytes at 2-8°C (exceptions: Ferritin and CA 27-29 stable for 6 days; ACTH, Free PSA, PSA, and Calcitonin require immediate assay). Frozen stability (-10°C to -20°C) was validated for 30 days. Shelf life is 3 years and 3 months at 2-8°C.

Technological Characteristics

Human serum-based control; lyophilized form; stored at 2-8°C unopened. Analyte stability validated for specific durations post-reconstitution and post-freezing. No electronic, software, or energy-based components.

Indications for Use

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

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 Marker Control (K992172)

Submission Summary (Full Text)

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Page 1 of 3

K011579

# JUN 2 6 2001

Summary of Safety and Effectiveness Lyphochek® Tumor Marker Control

#### 1.0 Submitter

Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: [phone] [phone] Fax:

# Contact Person

Yvette Lloyd Senior Regulatory Affairs Specialist Telephone: [phone]

# Date of Summary Preparation

May 18, 2001

### 2.0 Device Identification

Lyphochek® Tumor Marker Control Product Trade Name:

Multi-Analyte Controls, (Assayed and unassayed) Common Name:

| Classifications: | Class I |
|--------------------|--------------|
| Product Code: | 75JJY |
| Regulation Number: | CFR 862.1660 |

# Device to Which Substantial Equivalence is Claimed 3.0

Lyphochek® Tumor Marker Control Bio-Rad Laboratories Irvine, California

Docket Number: K992172

### 4.0 Description of Device

Lyphochek® Tumor Marker Control is prepared from human serum with added constituents of human origin and pure chemicals.

The control is provided in lyophilized form for increased stability

06_510(k) Itm_580 05/01

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## Statement of Intended Use 5.0

Lyphochek® Tumor Marker Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for analytes listed in this package insert.

## Comparison of the new device with the Predicate Device 6.0

The new Lyphochek® Tumor Marker Control claims substantial equivalence to the Lyphochek® Tumor Marker Control currently in commercial distribution (K992172). The new Lyphochek® Tumor Marker Control has improved open-vial stability claims for CA 27-29, and improved reconstituted freeze-thaw stability claims for PSA, Calcitonin, and ACTH.

| | Bio Rad | Bio Rad |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | Lyphochek® Tumor Marker Control | Lyphochek® Tumor Marker Control |
| | (New Device) | (Predicate Device) |
| Similarities | | |
| Intended Use | The Lyphochek® Tumor Marker<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<br>analytes listed in the package<br>insert. | The Lyphochek® Tumor Marker<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. |
| Form | Lyophilized | Lyophilized |
| Matrix | Human serum based | Human serum based |
| Storage<br>(Unopened) | 2°C to 8°C<br>until expiration date | 2°C to 8°C<br>until expiration date |
| Differences | | |
| Open<br>Vial Claim | All analytes will be stable for 14<br>days when stored at 2 - 8°C with<br>the following exceptions: Ferritin<br>and CA 27-29 will be stable for 6<br>days. ACTH, Free PSA, PSA, and<br>Calcitonin should be assayed<br>immediately following<br>reconstitution. | All analytes will be stable for 14<br>days when stored at 2 - 8°C with<br>the following exceptions: ACTH,<br>Free PSA, PSA, and Calcitonin<br>should be assayed immediately<br>following reconstitution. |
| Reconstituted<br>Freeze Vial<br>Claim | All analytes will be stable after<br>reconstituting and freezing for 30<br>days when stored at -10°C to -20<br>°C. | All analytes will be stable for 30<br>days after reconstituting and<br>freezing when stored at -10°C to -<br>20 °C, with the following<br>exceptions: (1) PSA will be stable<br>for 20 days and (2) ACTH and |

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

06_510(k) ltm 580 05/01

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| Calcitonin do not have frozen |
|------------------------------------------------------------------------------------------------------------------------------------------------------|
| stability claims.<br>Company of the comments of the first for the commend of the Research and AMER Management of AMERICAN Company of CARRANT Program |

#### 7.0 Summary of Performance Data

Stability studies have been performed to determine the open vial stability and shelf life for the Lyphochek® Tumor Marker Control. Product claims are as follows:

- 7.1 Once the control is reconstituted, all analytes will be stable for 14 days when stored tightly capped at 2 - 8°C, with the following exceptions: Ferritin and CA 27-29 will be stable for 6 days. ACTH, Free PSA, PSA, PSA, and Calcitonin should be assayed immediately following reconstitution. For optimum precision of Ferritin, allow vial to equilibrate for a minimum of 2 hours prior to assay.
- 7.2 After reconstituting and freezing the control, all analytes will be stable for 30 days when stored tightly capped at -10℃ to -20 ℃. Once thawed, do not refreeze the control; discard remaining material.
- 7.3 The control is stable for 3 years and 3 months when stored unopened at 2 - 8°C.

Real time studies will be ongoing to support the shelf life of this product.

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

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JUN 2 6 2001

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Donna Chapman Quality Assurance/Regulatory Affairs Manager Bio-Rad Laboraties, QSD 9500 Jeronimo Road Irvine, CA 92618-2017

510(K) Number: K011579 Re: Trade/Device Name: Lyphochek® Tumor Marker Control Regulation Number: 862.1660 Regulatory Class: I Product Code: JJY Dated: May 18, 2001 Received: May 22, 2001

Dear Ms. Chapman:

We have reviewed your Section 510(k) notification of intent to market the device referenced with have loviewed your betermined the device is substantially equivalent (for the indications for use atoo in the enclosure) to legally marketed predicate devices marketed in interstate commerce sured in and 28, 1976, the enactment date of the Medical Device Amendments, or to devices that provision associated in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Oostions of the Act. The general controls provisions of the Act include requirements for annual profistration, 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

This letter will allow you to begin marketing your device as described in your 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K011579 510 (k) Number (if known):_

Device Name: Lyphochek® Tumor Marker Control

Indications for Use:

An assayed quality control serum to monitor the precision of laboratory testing procedures for analytes listed in the package insert.

Signature

(Division Sign-Off) Division of Clinical Laboratory Devices K011579 510(k) Number _

(PLEASE DO NOT WRITE BELOW THE LINE-CONINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use
or

Over-the Counter use