ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL

K974261 · Boston Biomedica, Inc. · LJK · Dec 11, 1997 · Microbiology

Device Facts

• Record ID: K974261
• Device Name: ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL
• Applicant: Boston Biomedica, Inc.
• Product Code: LJK · Microbiology
• Decision Date: Dec 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3780
• Device Class: Class 2

Intended Use

ACCURUN™ 135 Toxoplasma IgG 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 IgG antibodies to Toxoplasma gondii. This control is not intended as a substitute for controls provided with test kits. ACCURUN™ 135 control is intended to estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures.

Device Story

ACCURUN™ 135 is a human blood-based, single-analyte, unassayed run control; contains human serum/plasma with IgG antibodies to Toxoplasma gondii; nonreactive for HIV 1/2, HTLV I, and HCV antibodies. Includes stabilizers (EDTA, buffering agents) and 0.1% ProClin™ preservative. Used by clinical laboratory professionals in public health and clinical settings to estimate testing precision and detect procedural errors in Toxoplasma gondii IgG assays. Not a substitute for kit-provided controls. Supplied in 1 ml or 5 ml vials; stored at 2-8°C; stable for 60 days after opening. Healthcare providers use the control alongside patient samples to verify assay performance; results help ensure laboratory testing accuracy and reliability.

Clinical Evidence

Clinical laboratory evaluations performed at BBI and two external clinical laboratories. Data collected to evaluate consistency and performance of ACCURUN™ 135 as an independent run control. Testing included five stability studies (real-time, ambient, heat stress, freeze-thaw, open-vial). Results demonstrated stability at 2-8°C, resistance to multiple freeze-thaw cycles, and stability for at least 60 days after opening. Clinical trial data confirmed safety and effectiveness across three laboratories using three manufactured lots under various stress conditions.

Technological Characteristics

Human serum/plasma-based control; contains IgG antibodies to Toxoplasma gondii; nonreactive for HIV 1/2, HTLV I, and HCV. Additives: EDTA, buffering agents, 0.1% ProClin™ preservative. Form factor: 1 ml or 5 ml liquid vials. Storage: 2-8°C. No electronic, software, or mechanical components.

Indications for Use

Indicated for use by clinical laboratory professionals in public health and clinical laboratories as an independent run control for in vitro diagnostic tests detecting IgG antibodies to Toxoplasma gondii in human serum and plasma. Not cleared for use in testing blood or plasma donors.

Regulatory Classification

Identification

Toxoplasma gondii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Toxoplasma gondii in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Toxoplasma gondii from clinical specimens. The identification aids in the diagnosis of toxoplasmosis caused by the parasitic protozoan Toxoplasma gondii and provides epidemiological information on this disease. Congenital toxoplasmosis is characterized by lesions of the central nervous system, which if undetected and untreated may lead to brain defects, blindness, and death of an unborn fetus. The disease is characterized in children by inflammation of the brain and spinal cord.

Submission Summary (Full Text)

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# DEC I I 1997

Boston Biomedica, Inc. 510(k) Notification ACCURUN™ 135 Toxoplasma IgG Positive Control

# SUMMARY OF SAFETY AND EFFECTIVENESS FOR

### Boston Biomedica, Inc.'s

## ACCURUN™ 135

Reference No:

Product Name: ACCURUN™ 135 Toxoplasma IgG Positive Control

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

#### Indications for use 1.

ACCURUN™ 135 Toxoplasma IgG 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 IgG antibodies to Toxoplasma gondii. This control is not intended as a substitute for controls provided with test kits.

ACCURUN™ 135 control is intended to estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures.

#### Device description 2.

ACCURUN™ 135 Toxoplasma IgG Positive Control is manufactured from human serum or plasma containing IgG antibodies to Toxoplasma gondii, 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™ 135 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 IgG antibodies to Toxoplasma gondii in human serum and plasma.

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This control is supplied as 1 x 1 ml vial or 1 x 5 ml vial. ACCURUN™ 135 should be stored at 2-8°C. Once opened, ACCURUN™ 135 should be discarded after 60 days.

#### Existing products and practices 3.

Controls of the type represented by Boston Biomedica's ACCURUN™ 135 Toxoplasma IgG 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™ 135 is substantially equivalent to other commercially available unassaved. single analyte and multi-analyte independent run controls.

#### Summary of studies 4.

BBI performed five types of stability studies to support the labeling and storage conditions for ACCURUN™ 135 Toxoplasma IgG 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 and at two clinical laboratories. The data provided by these external laboratories were collected to evaluate the consistency and performance of ACCURUN™ 135 as an independent run control in situations where it is most likely to be used.

#### 5. Conclusions drawn from studies

We have performed extensive testing to determine the stability of ACCURUN™ 135 Toxoplasma IgG Positive Control under various environmental and user conditions. The data suggest that ACCURUN™ 135 can be stored at 2-8°C in its vialed form and is not affected by multiple freeze-thaw cycles. ACCURUN™ 135 is stable at ambient temperatures and under heat stress for a short period of time with no adverse effects. ACCURUN™ 135 remains stable even after the vials have been repeatedly opened and stored at 2-8℃ for at least 60 days.

The clinical trial data demonstrate that ACCURUN™ 135 is safe and effective in three different laboratories with three manufactured ACCURUN™ 135 lots, and under various conditions of stress.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle symbol, with three curved lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC I I 1997

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

Re: K974261 Trade Name: ACCURUN™ 135 Toxoplasma IgG Positive Control Regulatory Class: II Product Code: LJK Dated: November 12, 1997 Received: November 13, 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 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 vours.

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 lif known):_K974261

ACCURUN™ 135 Toxoplasma IgG Positive Control Device Name:

Indications For Use: ·

Boston Biomedica intends to manufacture and market ACEURUN™ 135 Toxoplasma IgG 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 IgG antibodies to Toxoplasma gondii. 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.

: . .

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

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|------------------------------|
| John Ticknust MD | |
| (Division Sign-Off) Interim Chief, Microbial Brand | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | ____________________________ |

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