LYPHOCHEK IMMUNOASSAY PLUS CONTROL

K981532 · Bio-Rad · JJY · May 12, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981532
• Device Name: LYPHOCHEK IMMUNOASSAY PLUS CONTROL
• Applicant: Bio-Rad
• Product Code: JJY · Clinical Chemistry
• Decision Date: May 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

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

Device Story

Lyphochek Immunoassay Plus Control is an assayed quality control serum used by laboratory professionals to monitor the precision of immunoassay testing procedures. The device is prepared from human serum supplemented with human-derived constituents, pure chemicals, and therapeutic drugs. It is provided in a lyophilized form to ensure stability and must be reconstituted before use. The control is stored at 2-8°C. Healthcare providers use the control to verify the accuracy and precision of their diagnostic testing systems by comparing results against established values. This monitoring helps ensure the reliability of patient test results, thereby supporting clinical decision-making.

Clinical Evidence

No clinical data. The submission relies on bench testing and comparison of technological characteristics to the predicate device.

Technological Characteristics

Lyophilized human serum control; contains human-derived constituents, pure chemicals, and therapeutic drugs. Storage at 2-8°C. Reconstituted stability is 7 days at 2-8°C, with specific exceptions for C-Peptide, Folate, PSA (3 days), and ACTH, Calcitonin, Gastrin (immediate use).

Indications for Use

Indicated for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for clinical laboratory professionals.

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 (K891475)

Submission Summary (Full Text)

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K981532

Image /page/0/Picture/1 description: The image shows the logo for BIO-RAD. Below the logo, the date MAY 12 1998 is printed. The logo is in bold, black letters, and the date is in a smaller, less bold font. The image is black and white.

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

## 510(k) Summary

Submitter Bio-Rad Laboratories 9500 Jeronimo Road Irvine. CA [phone] Fax [phone]

Contact Person Elizabeth Platt

Date of Summary Preparation April 28, 1998

Device (Trade & Common Name) Lyphochek Immunoassay Plus Control

Classification Name CFR 862.1660: Quality Control Material (Assayed and Unassayed)

Devices to Which Substantial Equivalence is Claimed Lyphochek Immunoassay Plus Control Bio-Rad Laboratories, Irvine, CA K891475

Statement of Intended Use

Lyphochek Immunoassay Plus Control is intended for use as an assayed quality control serum 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. The logo is in a rounded rectangle shape. The text "BIO+RAD" is in white, and the background is black.

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

## Description of the Device

Lyphochek Immunoassay Plus Control is prepared from human serum, with added constituents of human origin, pure chemicals and therapeutic drugs. 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 Immunoassay Plus Control and the device to which substantial equivalence is claimed.

| | Bio-Rad Lyphochek<br>Immunoassay Plus Control | Bio-Rad Lyphochek<br>Immunoassay Plus Control<br>(new submission) |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | An assayed quality control<br>serum to monitor the<br>precision of laboratory<br>testing procedures for the<br>analytes listed in the<br>package insert. | An assayed quality control<br>serum to monitor the<br>precision of laboratory<br>testing procedures for the<br>analytes listed in the<br>package insert. |
| Form | Lyophilized | Lyophilized |
| Matrix | Human Serum | Human Serum |
| Storage | 2-8°C | 2-8°C |
| Reconstituted<br>Stability<br>Claim | 7 days at 2-8°C with the<br>following exceptions: (1) C-<br>Peptide, Folate and PSA<br>are stable for 3 days after<br>reconstitution, (2) ACTH,<br>Calcitonin and Gastrin<br>should be assayed<br>immediately after<br>reconstitution. | 7 days at 2-8°C with the<br>following exceptions: (1) C-<br>Peptide, Folate and PSA are<br>stable for 3 days after<br>reconstitution, (2) ACTH,<br>Calcitonin and Gastrin<br>should be assayed<br>immediately after<br>reconstitution. |
| Differences | Current product does not<br>have claims for the<br>following: Total Estrogens,<br>Flecainide, IgA, IgG, IgM,<br>Iron, TIBC, Netilmicin,<br>SHBG. | Product has added claims<br>for the following: Total<br>Estrogens, Flecainide, IgA,<br>IgG, IgM, Iron, TIBC,<br>Netilmicin, SHBG. |

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 1 2 1998

Elizabeth Platt . Acting Requlatory Affairs/Quality Assurance Bio Rad Laboratories 9500 Jeronimo Road Irvine, California 92618-2017

K981532 Re : Lyphochek Immunoassay Plus Control Requlatory Class: I Product Code: JJY Dated: April 28, 1998 Received: April 29, 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 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 The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 Requlations, Title 21, Parts 800 to 895. ਰ 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 In addition, FDA may publish further announcements action. 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 requlations.

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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/dsmamain.html".

Sincerely yours,
Steven Litman

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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510(k) Number: _ Device Name: Lyphochek Immunoassay Plus Control

Indications for Use:

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

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| | (Concurrence of CDRH, Office of Device Evaluation) | |
|------------------|------------------------------------------------------------------|-------------------------|
| Prescription Use | <div> <img alt="Checkmark" src="prescription_check.png"/> </div> | OR Over-The Counter Use |

Veronica J. Caluin for A Montgomery

(Division Sign-Off)

Division of Clinical Laboratory Devices

| Number | K981532 |
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