LYPHOCHEK MATERNAL SERUM CONTROL, MODEL 220

K984594 · Bio-Rad · JJY · Feb 2, 1999 · Clinical Chemistry

Device Facts

• Record ID: K984594
• Device Name: LYPHOCHEK MATERNAL SERUM CONTROL, MODEL 220
• Applicant: Bio-Rad
• Product Code: JJY · Clinical Chemistry
• Decision Date: Feb 2, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Lyphochek Maternal Serum Control is intended for use as an assayed quality control to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Device Story

Lyphochek Maternal Serum Control is an in vitro diagnostic product used in clinical laboratories to monitor the precision of testing procedures. It consists of human serum supplemented with human-derived constituents, chemicals, and preservatives, provided in a lyophilized form for stability. Laboratory technicians reconstitute the control and use it alongside patient samples during routine testing for analytes including AFP, free estriol, and HCG-beta subunit. By comparing the measured values of the control against established ranges, clinicians verify the accuracy and precision of their testing systems. This quality control process ensures the reliability of diagnostic results, which are essential for clinical decision-making in maternal serum screening.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Lyophilized human serum matrix with added human-derived constituents, chemicals, and preservatives. Storage at 2-8°C. Open-vial stability of 10 days at 2-8°C. Analyte profile includes AFP, free estriol, and HCG-beta subunit.

Indications for Use

Indicated for use as an assayed quality control to monitor the precision of laboratory testing procedures for specific analytes in human serum. No specific patient population, age, or gender is defined as this is a laboratory control product.

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 Immunoassay Plus Control (K981532)

Submission Summary (Full Text)

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K984594

Image /page/0/Picture/2 description: The image shows the logo for BIO-RAD. The logo is in black and white, with the words "BIO-RAD" in bold, white letters against a black, rounded rectangle. The plus sign in the middle of the word is slightly larger than the other letters.

Laboratories

Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-201 Telephone: [phone]

# 510(k) Summary

Submitter Bio-Rad Laboratories, ECS Division 9500 Jeronimo Road Irvine, CA 92618 [phone] Fax [phone]

Contact Person Elizabeth Platt

Date of Summary Preparation December 22, 1998

Device (Trade & Common Name) Lyphochek Maternal Serum Control

Classification Name Class I, CFR 862.1660: Multi-Analyte Control (Assayed and Unassayed) 75JJY

Devices to Which Substantial Equivalence is Claimed Lyphochek Immunoassay Plus Control Bio-Rad Laboratories, Irvine, California K981532

#### Statement of Intended Use

Lyphochek Maternal Serum Control is intended for use as an assayed quality control to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

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Image /page/1/Picture/0 description: The image shows the logo for Bio-Rad Laboratories, a company that manufactures and distributes products for the life science research and clinical diagnostics markets. The logo is in black and white, with the words "BIO-RAD" in bold, sans-serif letters. The logo is simple and recognizable, and it is used on a variety of Bio-Rad products and marketing materials. The logo is enclosed in a black rounded rectangle.

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

## Description of the Device

Lyphochek Maternal Serum Control is prepared from human serum with added constituents of human origin, pure chemicals and preservatives. The control is provided in lyophilized form for increased stability.

## Statement of How Technological Characteristics Compare to Substantial Equivalence Device

A table is provided below comparing the similarities between the Bio-Rad Lyphochek Maternal Serum Control and the device to which substantial equivalence is claimed.

| | Bio-Rad Lyphochek Maternal<br>Serum Control | Bio-Rad Lyphochek Immunoassay<br>Plus Control |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | An assayed quality control serum<br>to monitor the precision of<br>laboratory testing procedures for<br>the analytes listed in the package<br>insert. | An assayed quality control serum<br>to monitor the precision of<br>laboratory testing procedures for<br>the analytes listed in the package<br>insert. |
| Form | Lyophilized | Lyophilized |
| Open<br>Vial<br>Claim | 10 days when stored tightly<br>capped at 2-8°C. | 7 days when stored tightly capped<br>at 2-8°C with the following<br>exceptions: (1) C-Peptide, Folate<br>and PSA are stable for 3 days<br>after reconstitution. (2) ACTH,<br>Calcitonin and Gastrin should be<br>assayed immediately after<br>reconstitution. |
| Matrix | Human serum | Human serum |
| Storage | 2-8°C | 2-8°C |
| Analytes | AFP (Alpha-Fetoprotein)<br>Estriol, Free<br>HCG-Beta Subunit | AFP (Alpha-Fetoprotein<br>Estriol, Free<br>HCG-Beta Subunit<br>Plus other analytes. |

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Public Health Service

2 1999 FEB

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Elizabeth Platt Regulatory Affairs Supervisor Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017

K984594 Re:

Trade Name: Lyphochek Maternal Serum Control Regulatory Class: I Product Code: JJY Dated: December 23, 1998 Received: December 28, 1998

Dear Ms. Platt:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (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 (OS) 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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"(21 CFR 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/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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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Page 1 of 1

510(k) Number: K984594
Device Name: Lyphochek Maternal Serum Control

Indications for Use:

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Lyphochek Maternal Serum Control is intended for use as an assayed quality control Lyphochek matermal Ocrain Somethor testing procedures for the analytes listed in the package insert.

Cooper
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of Clinical Lan
510(k) Number
(Division Sign-Off)
Division of Clinical Laboratory Levices
K984594

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(Concurrence of CDRH, Office of Device Evaluation)

Prescription Use

Over-The Counter Use __ OR