MODIFICATION TO LIQUICHEK SPINAL FLUID CONTROL, ITEM NOS. 751, 752

K990888 · Bio-Rad · JJY · Apr 7, 1999 · Clinical Chemistry

Device Facts

• Record ID: K990888
• Device Name: MODIFICATION TO LIQUICHEK SPINAL FLUID CONTROL, ITEM NOS. 751, 752
• Applicant: Bio-Rad
• Product Code: JJY · Clinical Chemistry
• Decision Date: Apr 7, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Liquichek Spinal Fluid 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

Liquichek Spinal Fluid Control is a human-based liquid quality control product containing added constituents of human origin and pure chemicals; preserved with 0.1% sodium azide. Used in clinical laboratories to monitor the precision of testing procedures for analytes including albumin, chloride, glucose, immunoglobulins (A, G, M), lactate, total protein, sodium, and LDH. The control is stored at 2-8°C and has a 30-day open-vial stability. Laboratory personnel use the control to verify the accuracy and precision of their analytical systems; results help ensure the reliability of patient diagnostic testing.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Human-based liquid control matrix; contains 0.1% sodium azide preservative. Analytes: albumin, chloride, glucose, IgA, IgG, IgM, lactate, total protein, sodium, LDH. Storage: 2-8°C. Open-vial stability: 30 days.

Indications for Use

Indicated for use as an assayed quality control to monitor the precision of laboratory testing procedures for specific analytes in spinal fluid. Intended for clinical laboratory use.

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

• Liquichek Spinal Fluid Control (K932076)

Submission Summary (Full Text)

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4-7-99

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tories

A Jeronimo Roar e California 9261 elephone: (949) 598-1.

# 510(k) Summary

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

Contact Person Elizabeth Platt

Date of Summary Preparation March 8, 1999

Device (Trade & Common Name) Liquichek Spinal Fluid Control

Classification Name Class 1, 75JJY CFR 862.1660: Multi-Analyte Control, All Kinds (Assayed and Unassayed)

Devices to Which Substantial Equivalence is Claimed Liquichek Spinal Fluid Control Bio-Rad Laboratories Irvine, California K932076

#### Statement of Intended Use

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

#### Description of the Device

Liquichek Spinal Fluid Control is a human based control with added constituents of human origin and pure chemicals. This product is provided in liquid form for convenience.

This product contains 0.1% sodium azide as a preservative.

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

A table is provided below comparing the similarities between the Bio-Rad Liquichek Spinal Fluid Control and the devices to which substantial equivalence is claimed.

| | Bio-Rad Liquichek Spinal Fluid<br>Control (New Device) | Bio-Rad Liquichek Spinal Fluid<br>Control (Substantially Equivalent<br>Device) | |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| Intended<br>Use | An assayed quality control to monitor<br>the precision of laboratory testing<br>procedures for the analytes listed in<br>the package insert. | An assayed quality control to monitor<br>the precision of laboratory testing<br>procedures for the analytes listed in<br>the package insert. | |
| | Form | Liquid | Liquid |
| | Matrix | Human based control. | Human based control. |
| | Storage | 2-8°C | 2-8°C |
| | Open Vial<br>Claim | 30 days when stored tightly capped<br>at 2-8°C. | 30 days when stored tightly capped<br>at 2-8°C. |
| Analytes | Albumin, Chloride, Glucose,<br>Immunoglobulin A, Immunoglobulin<br>G, Immunoglobulin M, Lactate, Total<br>Protein, Sodium plus LDH. | Albumin, Chloride, Glucose,<br>Immunoglobulin A, Immunoglobulin<br>G, Immunoglobulin M, Lactate, Total<br>Protein, Sodium. | |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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#### APH 7 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Elizabeth Platt Staff Requlatory Affairs Representative BIO-RAD LABORATORIES 9500 Jeronimo Road Irvine, CA 92618-2017

Re: K990888 Trade Name: Liquichek Spinal Fluid Control Regulatory Class: I Product Code: JJY March 8, 1999 Dated: March 10, 1999 Received:

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 requlations affecting your device can be found in the Code of Federal Requlations, 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. this response to your premarket notification Please note: 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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510(k) Number: Device Name: Liquichek Spinal Fluid Control

Indications for Use:

Liquichek Spinal Fluid 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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(Concurrence of CDRH, Office of Device Evaluation)

| (Division Sign-Off) | |
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| Division of Clinical Laboratory Devices | K990888 |
| 510(k) Number | |

| Prescription Use | <div> <span style="text-decoration: overline;">✓</span> </div> |
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OR Over-The Counter Use