ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL

K974810 · Boston Biomedica, Inc. · LSR · Feb 5, 1998 · Microbiology

Device Facts

• Record ID: K974810
• Device Name: ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL
• Applicant: Boston Biomedica, Inc.
• Product Code: LSR · Microbiology
• Decision Date: Feb 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3830
• Device Class: Class 2

Intended Use

ACCURUN™ 132 Borrelia burgdorferi IgM Positive Control is a human blood based single analyte unassayed run control designed to be used as an independent run control with tests for the detection of IgM antibodies to Borrelia burgdorferi (Lyme Disease). This control is not intended as a substitute for controls provided with test kits. This product is not FDA cleared for use in testing blood or plasma donors. This product will be made available to clinical laboratory professionals in public health laboratories and clinical laboratories for use with in vitro diagnostic tests for the detection of IgM antibodies to Borrelia burgdorferi in human serum.

Device Story

ACCURUN™ 132 is a human serum/plasma-based, single-analyte, unassayed run control; contains IgM antibodies to Borrelia burgdorferi; nonreactive for HIV 1/2, HTLV I, and HCV. Used by clinical laboratory professionals in public health and clinical labs to estimate testing precision and detect procedural errors in Lyme disease IgM antibody assays. Supplied as 1 ml vial; requires storage at -10°C or colder; stable for 60 days at 2-8°C after opening. Not a substitute for kit-specific controls. Provides independent verification of assay performance; helps ensure reliable clinical results for patients suspected of Lyme disease.

Clinical Evidence

Clinical laboratory evaluations performed at BBI, one blood bank, and one clinical laboratory. Data demonstrated consistency and performance of the control across three lots and various stress conditions. Stability studies included real-time, ambient, heat stress, freeze-thaw, and open-vial testing, confirming stability at -10°C or colder and 60-day stability at 2-8°C.

Technological Characteristics

Human serum/plasma-based control; contains stabilizers (EDTA, buffering agents) and 0.1% ProClin™ preservative. Supplied as 1 ml liquid vial. Storage: -10°C or colder. No electronic or software components.

Indications for Use

Indicated for use by clinical laboratory professionals as an independent run control for in vitro diagnostic tests detecting IgM antibodies to Borrelia burgdorferi in human serum. Not for use in testing blood or plasma donors.

Regulatory Classification

Identification

Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control reagents (standardized reagents with which test results are compared) which are derived from treponemal sources and that are used in the fluorescent treponemal antibody absorption test (FTA-ABS), the Treponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies to Treponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genus Treponema and provides epidemiological information on syphilis.

Submission Summary (Full Text)

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Boston Biomedica, Inc. 510(k) Notification ACCURUN™ 132 Borrelia burgdorferi IgM Positive Control

# SUMMARY OF SAFETY AND EFFECTIVENESS

### Boston Biomedica, Inc.'s

FEB - 5 1998

## ACCURUN™ 132

Reference No:

Product Name: ACCURUN™ 132 Borrelia burgdorferi IgM Positive Control

Boston Biomedica, Inc. Sponsor: 375 West Street West Bridgewater, MA 02379

#### Indications for use 1.

ACCURUN™ 132 Borrelia burgdorferi IgM Positive Control is a human blood based single analyte run control designed to be used as an independent run control with tests for the detection of IgM antibodies to Borrelia burgdorferi (Lyme Disease). This control is not intended as a substitute for controls provided with test kits.

ACCURUN™ 132 control is intended to estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures.

#### 2. Device description

ACCURUN™ 132 Borrelia burgdorferi IgM Positive Control is manufactured from human serum or plasma containing IgM antibodies to Borrelia burgdorferi, but is nonreactive for antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV 1 and 2), antibodies to Human T-Lymphotropic Virus Type I (HTLV I) and antibodies to Hepatitis C (HCV). This control contains stabilizers (EDTA, buffering agents) and 0.1% ProClin™ as preservative. The manufacturer recommends that the user observe the Centers for Disease Control (CDC) recommended Universal Precautions for handling ACCURUN™ 132 and all human blood.

This product will be made available to clinical laboratory professionals in public health laboratories and clinical laboratories for use with in vitro diagnostic tests for the detection of IgM antibodies to Borrelia burgdorferi in human serum.

This control is supplied as 1 x 1 ml vial. ACCURUN™ 132 should be stored at -10°C or colder. Once opened, ACCURUN™ 132 should be stored at 2-8°C and discarded after 60 days.

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### Existing products and practices 3.

Controls of the type represented by Boston Biomedica's ACCURUN™ 132 Borrelia burgdorferi IgM Positive Control are relatively new in serology testing for infectious disease markers, but have been in routine use for years with clinical laboratory tests in chemistry and other immunoassay areas. ACCURUN™ 132 is substantially equivalent to other commercially available unassayed, single analyte and multi-analyte independent run controls.

#### 4. Summary of studies

BBI performed five types of stability studies to support the labeling and storage conditions for ACCURUN™ 132 Borrelia burgdorferi IgM Positive Control. These include real time, ambient temperature, heat stress, freeze-thaw and open vial stability studies.

In addition, clinical laboratory evaluations were performed at BBI, one blood bank and one clinical laboratory. The data provided by these external laboratories were collected to evaluate the consistency and performance of ACCURUN™ 132 as an independent run control in situations where it is most likely to be used.

### Conclusions drawn from studies ഗ്

We have performed extensive testing to determine the stability of ACCURUN™ 132 Borrelia burgdorferi IgM Positive Control under various environmental and user conditions. The data suggest that ACCURUN™ 132 can be stored at -10°C or colder in its vialed form and is not affected by multiple freeze-thaw cycles. ACCURUN™ 132 is stable at ambient temperatures and under heat stress for a short period of time with no adverse effects. ACCURUN™ 132 remains stable for at least 60 days at 2-8°C, even after the vials have been repeatedly opened.

The clinical trial data demonstrate that ACCURUN™ 132 is safe and effective in three different laboratories with three manufactured ACCURUN™ 132 lots, and under various conditions of stress.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the wings and body, and the overall design is simple and clean.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB - 5 1998

Patricia E. Garrett, Ph.D. Senior Vice President Strategic Programs and Regulatory Affairs Boston Biomedica, Inc. 375 West Street W. Bridgewater, MA 02379

Re: K974810

Trade Name: ACCURUN™ 132 Borrelia burgdorferi IgM Positive Control Regulatory Class: II Product Code: LSR Dated: December 22, 1997 Received: December 23, 1997

Dear Dr. Garrett:

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

Sincerely yours.

Steven Autman

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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Boston Riomedica, Inc. 510(k) Notification ACCURUN™ 132 Borrelia burgdorferi IgM Positive Control

> of Page

510(k) Number (if known):

Device Name: ACCURUN™ 132 Borrelia burgdorferi IgM Positive Control

Indications For Use:

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Boston Biomedica intends to manufacture and market ACCURUN™ 132 Borrelia burgdorferi IgM Positive Control, which is a human blood based single analyte unassayed run control designed to be used as an independent run control with tests for the detection of IgM antibodies to Borrelia burgdorferi (Lyme Disease). This control is not intended as a substitute for controls provided with test kits. This product is not FDA cleared for use in testing blood or plasma donors.

This product will be made available to clinical laboratory professionals in public health laboratories and clinical laboratories for use with in vitro diagnostic tests for the detection of IgM antibodies to Borrelia burgdorferi in human serum.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

*Zo Haw*

(Division Sign-Off)

| Division of Clinical Laboratory Devices | |
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| 510(k) Number | K974810 |

| Prescription Use<br>(Per 21 CFR 801.109) | <div> <svg height="15" width="15"> <path d="M3 7 L7 11 L13 5" fill="none" stroke="black" stroke-width="2"></path> </svg> </div> | OR | Over-The-Counter Use |
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