VIROTROL III

K974613 · Blackhawk Biosystems, Inc. · JJY · Jan 27, 1998 · Clinical Chemistry

Device Facts

• Record ID: K974613
• Device Name: VIROTROL III
• Applicant: Blackhawk Biosystems, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jan 27, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

VIROTROL III quality assurance reagent is a liquid unassayed human serum based quality control material intended for use with in vitro assay procedures for determination of immunoglobulin M antibodies to Hepatitis A Virus(HAV-IgM), immunoglobulin M antibodies to Hepatitis B core Antigen(HBc-IgM), Hepatitis B e Antigen(HBeAg) and total antibody to Hepatitis A Virus(anti-HAV). VIROTROL III reagents are intended to provide a means of estimating precision and have the potential for detecting systematic deviations from specific laboratory testing procedures.

Device Story

Virotrol III is a liquid, unassayed, human serum-based quality control reagent. Used in clinical laboratory settings by laboratory personnel to monitor the performance of in vitro diagnostic assays for Hepatitis A and B markers (HAV-IgM, HBc-IgM, HBeAg, anti-HAV). The device serves as a control sample processed alongside patient specimens to estimate assay precision and identify systematic deviations in testing procedures. It provides healthcare providers with assurance regarding the reliability of laboratory test results, facilitating accurate clinical decision-making for patients undergoing hepatitis screening or diagnostic testing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Liquid, unassayed, human serum-based quality control material. Designed for in vitro diagnostic use. No electronic, software, or mechanical components.

Indications for Use

Indicated for use as a quality control material in clinical laboratories performing in vitro diagnostic assays for HAV-IgM, HBc-IgM, HBeAg, and anti-HAV antibodies to monitor precision and detect systematic testing deviations.

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.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 27 1998

Ms. Carole Polito President Blackhawk BioSystems, Inc. 12945 Alcosta Blvd. San Ramon, CA 94583

Re: K974613

> Trade Name: Virotrol III Regulatory Class: I Product Code: JJY Dated: December 9, 1997 Received: December 11, 1997

Dear Ms. Polito:

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 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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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 at [phone] or at its internet address "http://www.fda.gov/cdrh/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):______________________________________________________________________________________________________________________________________________________

Device Name: VIROTROL III

Indications For Use:

VIROTROL III quality assurance reagent is a liquid unassayed human serum based quality control material intended for use with in vitro assay procedures for determination of immunoglobulin M antibodies to Hepatitis A Virus(HAV-IgM), immunoglobulin M antibodies to Hepatitis B core Antigen(HBc-IgM), Hepatitis B e Antigen(HBeAg) and total antibody to Hepatitis A Virus(anti-HAV). VIROTROL III reagents are intended to provide a means of estimating precision and have the potential for detecting systematic deviations from specific laboratory testing procedures.

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Concurrence of CDRH, Office of Device Evaluation(ODE)

John Tichurst M.D

Division of Clinical Laboratory Devices
510(k) Number K974613

**Prescription Use**
(Per 21 CFR 801.109)

OR

Over-The Counter Use___

(Optional Format 1-2-96)