QUALITROL DHP IMMUNOASSAY CONTROL LEVELS 1,2 AND 3, CONFORMANCEE MCC-LIGAND CONTROL LEVELS 1, 2 AND 3

K972080 · Consolidated Technologies, Inc. · JJY · Jun 18, 1997 · Clinical Chemistry

Device Facts

• Record ID: K972080
• Device Name: QUALITROL DHP IMMUNOASSAY CONTROL LEVELS 1,2 AND 3, CONFORMANCEE MCC-LIGAND CONTROL LEVELS 1, 2 AND 3
• Applicant: Consolidated Technologies, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jun 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Clinical laboratories, performing immunoassays for drugs, hormones and proteins on automated immunoassay systems may use Qualitrol Immunoassay DHP Control or CONFORMANCE MCC-Ligand Control routinely as a means of estimating precision and monitoring test system performance, provided: (a) the above mentioned controls, provided as a set (Levels 1, 2 3) are used as an adjunct to primary control procedure and recommended by the manufacturer of immunoassay systems. (b) above mentioned controls are used in accordance with the quality control requirements of regulatory and/or accrediting organizations and laboratory's quality control goals; (c ) above mentioned controls are validated for use with the specific immunoassay test system being used by the clinical laboratory. These controls have been assayed with AxSYM, IMx and TDX systems manufactured by Abbott Laboratories (Abbott Park, USA). The expected values, for these systems, are included in the package insert. The controls may be used as assayed controls for the stated indication for use when measurements are made with above-mentioned immunoassay systems.

Device Story

Qualitrol DHP Immunoassay Control (Levels 1, 2, 3) serves as quality control material for automated immunoassay systems. Used by clinical laboratory personnel to estimate precision and monitor test system performance. Controls are assayed for specific Abbott Laboratories systems (AxSYM, IMx, TDX). Expected values provided in package insert. Used as adjunct to primary control procedures to ensure compliance with regulatory/accrediting quality control requirements. Validated for specific immunoassay test systems to verify measurement accuracy and system stability.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Assayed liquid control set (Levels 1, 2, 3) for immunoassay systems. Formulated for use with drugs, hormones, and proteins. No specific materials or software algorithms described.

Indications for Use

Indicated for use in clinical laboratories as an assayed control for monitoring precision and performance of automated immunoassay systems measuring drugs, hormones, and proteins.

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.

Reference Devices

• AxSYM system (Abbott Laboratories)
• IMx system (Abbott Laboratories)
• TDX system (Abbott Laboratories)

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 18 1997

Vipin D. Shah

· Chief Operating Officer Consolidated Technologies, Inc. 2170 Woodward Street Austin, Texas 78744-1832

K972080 Re: Qualitrol DHP Immunoassay Control Levels 1, 2, and 3 Regulatory Class: I Product Code: JJY Dated: May 31, 1997 Received: June 3, 1997

Dear Mr. Shah:

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 of the Act. The general controls provisions 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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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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## INDICATION FOR USE

## Device Name: Qualitrol DHP Immunoassay Control CONFORMANCE MCC-Ligand Control

Indication for Use: Clinical laboratories, performing immunoassays for drugs, hormones and proteins on automated immunoassay systems may use Qualitrol Immunoassay DHP Control or CONFORMANCE MCC-Ligand Control routinely as a means of estimating precision and monitoring test system performance, provided:

(a) the above mentioned controls, provided as a set (Levels 1, 2 3) are used as an adjunct to primary control procedure and recommended by the manufacturer of immunoassay systems.

(b) above mentioned controls are used in accordance with the quality control requirements of regulatory and/or accrediting organizations and laboratory's quality control goals;

(c ) above mentioned controls are validated for use with the specific immunoassay test system being used by the clinical laboratory.

These controls have been assayed with AxSYM, IMx and TDX systems manufactured by Abbott Laboratories (Abbott Park, USA). The expected values, for these systems, are included in the package insert. The controls may be used as assayed controls for the stated indication for use when measurements are made with above-mentioned immunoassay systems.

Aller) City

(Division Sign Off)
Division of Clinical Laboratory Devic
510(k) Number 2972080

CICF +1x (cui