QUALITROL IMMUNOLOGY CONTROL, LEVEL 1, 2 AND 3

K992770 · Seracare Technology · JJY · Nov 12, 1999 · Clinical Chemistry

Device Facts

• Record ID: K992770
• Device Name: QUALITROL IMMUNOLOGY CONTROL, LEVEL 1, 2 AND 3
• Applicant: Seracare Technology
• Product Code: JJY · Clinical Chemistry
• Decision Date: Nov 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Qualitrol Immunology Control is a Iyophilized human serum based assayed quality control material intended to monitor the performance of serum immunological test procedures that analyze immunoglobulins and other serum proteins.

Device Story

Qualitrol Immunology Control is a lyophilized, human serum-based quality control material containing 26 analytes of clinical significance and 0.1% sodium azide. It is used in clinical laboratory settings to monitor the performance of immunological test procedures that analyze immunoglobulins and other serum proteins. The device is provided in three levels in 5.0 mL vials. Laboratory personnel use the control by running it alongside patient samples in standard immunological assays; the resulting values are compared against established ranges to verify the precision and accuracy of the testing procedure. This monitoring helps ensure the reliability of clinical diagnostic results for patients.

Clinical Evidence

No clinical data. Substantial equivalence is based on comparison of intended use and physical properties to a commercially available predicate device.

Technological Characteristics

Lyophilized human serum-based matrix; contains 26 analytes and 0.1% sodium azide preservative. Provided in 5.0 mL vials. Storage at 2-8°C. Stability maintained until expiration date on label.

Indications for Use

Indicated for use as an assayed quality control material to monitor the performance of clinical immunological test procedures analyzing immunoglobulins and other serum proteins in human serum samples.

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 IMMUNOLOGY CONTROL, BIO-RAD Laboratories (K-945651)

Submission Summary (Full Text)

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## NOV 1 2 1999

# Product Performance and Substantial Equivalency

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: _ _ 992720

SeraCare Technology, Inc. DBA Consolidated Technologies Submitter: 2170 Woodward Street Austin, TX 78744-1832 Phone: [phone] Fax: [phone]

Preparation date: August 13, 1999 Contact: Rusty Sewell

### Product name (trade & common):

Proprietary: Qualitrol Immunology Control, Levels 1, 2 and 3 Common: Not Applicable

### Classification name:

Class 1 . Product code: JJY 21 CFR 862:1660 : Multi-Analyte Controls, All Kinds (Assayed and Unassayed)

#### Predicate device:

LIQUICHEK IMMUNOLOGY CONTROL, BIO-RAD Laboratories K-945651

### Device description:

Qualitrol Immunology Control, is designed to monitor the performance of test procedures that analyze immunoqlobulin and other proteins in serum. Human origin components are added to a human serum based matrix. The product contains 0.1% sodium azide. Qualitrol Immunology Control will be offered in three levels of 5.0 mL fill vials.

### Intended use:

Qualitrol Immunology Control is a Iyophilized human serum based assayed quality control material intended to monitor the performance of serum immunological test procedures that analyze immunoglobulins and other serum proteins.

Labeling: Vial labels see Attachments I Secondary Container label, see Attachments II Package Insert, see Attachment III

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### Product Performance and Substantial Equivalency

510(k) Summary (continued)

### Comparative analysis:

The table below provides a summary of the technological characteristics between Qualitrol Immunology Control and the predicate device.

| Device<br>Characteristic | Qualitrol Immunology<br>Control | Liquichek™ Immunology Plus<br>Control |
|--------------------------|--------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Intended use | Assayed quality control serum for<br>monitoring performance of serum<br>immunological test procedures. | Assayed quality control serum for<br>monitoring precision of laboratory<br>testing procedures. |
| Matrix | Human Serum | Human Serum |
| Form | Lyophilized | Liquid |
| Analytes | 26 analytes of clinical significance<br>that may be found in serum. | 24 analytes |
| Storage | 2-8°C | 2-8°C |
| Stability | Until expiration date noted on vial<br>label. | Until expiration date noted on vial<br>label |

### Conclusions:

The information provided in the pre-market notification demonstrates that Qualitrol Immunology Control is substantially equivalent to the predicate device, for which there is FDA clearance. This equivalence was demonstrated through comparison of intended uses and physical properties to a commercially available device. The information supplied in the pre-market notification provides reasonable assurance that Qualitrol Immunology Control is safe and effective for the stated intended use.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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NOV 1 2 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Rusty Sewell Product Development Engineer SeraCare Technology, Inc. DBA, Consolidated Technologies 2170 Woodward Street Austin, Texas 78744-1832

K992770 Re:

Trade Name: Qualitrol Immunology Control, Level 1, 2 and 3 Regulatory Class: I Product Code: JJY Dated: August 13, 1999 Received: August 17, 1999

### Dear Mr. Sewell:

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 (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

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/cdrl/dsma/dsmamain.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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510(k) Number (if known): \$993720

Device Name:__________________________________________________________________________________________________________________________________________________________________

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Indications For Use:

Qualitrol Immunology Control, Level 1, 2 and 3 Device name: Indications for use:

Qualitrol Immunology Control, Level 1, 2 and 3, is a lyophilized human serum based assayed quality control material intended to monitor the performance of clinical immunological test procedures that analyze immunoglobulins and other serum proteins.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K992770 |

| Prescription Use | | OR | Over-The-Counter Use |
|----------------------|--|----|--------------------------|
| (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) |