QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS

K972146 · Consolidated Technologies, Inc. · LYR · Jul 8, 1997 · Microbiology

Device Facts

• Record ID: K972146
• Device Name: QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS
• Applicant: Consolidated Technologies, Inc.
• Product Code: LYR · Microbiology
• Decision Date: Jul 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3110
• Device Class: Class 1

Indications for Use

Qualitrol Unassayed H. Pylori Control Set, consisting of positive and negative human serum based controls, may be used by laboratories, performing immunoassays for qualitative determination of Helicobacter pylori IgG antibody in human serum, routinely as a means of estimating precision and systematic shift in accuracy, provided: (a.) above mentioned controls are used as an adjunct to reagents provided by kit manufacturers and according to the recommended procedure provided specifically for the test system being used by the laboratory; (b.) above mentioned controls are validated for use with the test system being used: (c.) above mentioned controls are used in accordance with the quality control requirement of regulatory and/or accrediting organizations and laboratory quality control goals.

Device Story

Qualitrol Unassayed H. Pylori Control Set comprises positive and negative human serum-based controls. Used by clinical laboratory personnel as adjuncts to commercial H. pylori IgG immunoassay test kits. Controls serve as quality control samples to monitor assay precision and systematic accuracy shifts. Operation follows standard laboratory quality control protocols and manufacturer-specific test system procedures. Benefits include standardized performance monitoring of diagnostic immunoassays, ensuring reliable qualitative detection of H. pylori IgG antibodies.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Human serum-based control set; positive and negative formulations; intended for use with existing immunoassay test systems; Class I device.

Indications for Use

Indicated for use by clinical laboratories as quality control material for immunoassays detecting Helicobacter pylori IgG antibodies in human serum to estimate precision and accuracy.

Regulatory Classification

Identification

Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identify Campylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases. Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. William Cone President JUL - 8 1997 Consolidated Technologies, Inc. 2170 Woodward Street Austin, Texas 78744-1832

Re: K972146 Trade Name: Qualitrol Unassayed H. Pylori Control Set (Positive and Negative Serum Controls) Requlatory Class: I Product Code: LYR Dated: June 6, 1997 Received: June 9, 1997

Dear Mr. Cone:

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 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices. Ceneral 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 GMF requlation 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 (301) Additionally, for questions on the promotion and 594-4588. 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 at [phone] or at its internet address "http://www.fda.gov/cdrh/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 (if known):

Device Name: __Qualitrol Unassayed H. Pylori Control Set Positive and Negative Serum Controls

Indications For Use:

Qualitrol Unassayed H. Pylori Control Set, consisting of positive and negative human serum based controls, may be used by laboratories, performing immunoassays for qualitative determination of Helicobacter pylori IgG antibody in human serum, routinely as a means of estimating precision and systematic shift in accuracy, provided:

(a.) above mentioned controls are used as an adjunct to reagents provided by kit manufacturers and according to the recommended procedure provided specifically for the test system being used by the laboratory;

(b.) above mentioned controls are validated for use with the test system being used:

(c.) above mentioned controls are used in accordance with the quality control requirement of regulatory and/or accrediting organizations and laboratory quality control goals.

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Tetti E. Mapin

(Division Sign-Off)
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Division of Clinical Laboratory Device's
510(k) Number

Prescription Use_V (Per 21 CFR 801.109)

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Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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