(44 days)
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No
The device is a positive control for laboratory tests and does not involve any computational analysis or algorithms.
No.
This device is a quality control material used to estimate laboratory testing precision and detect errors, not to treat or diagnose a disease.
No.
This device is a control used to estimate laboratory testing precision and detect errors, not to diagnose a patient's condition. While it is used with in vitro diagnostic tests, it is not itself a diagnostic device for patients.
No
The device description clearly states it is a human blood-based control material supplied in a vial, indicating it is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is "designed to be used as an independent run control with tests for the detection of IgM antibodies to Borrelia burgdorferi (Lyme Disease)." This indicates it is used in vitro (outside the body) to provide information about a patient's health status (presence of antibodies).
- Device Description: It is manufactured from human serum or plasma and is intended for use with "in vitro diagnostic tests for the detection of IgM antibodies to Borrelia burgdorferi in human serum."
- Target User: It is intended for "clinical laboratory professionals in public health laboratories and clinical laboratories," which are the typical users of IVD devices.
- Function: It functions as a "run control," which is a common type of IVD used to monitor the performance of diagnostic assays.
The description clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
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.
Product codes
LSR
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
clinical laboratory professionals in public health laboratories and clinical laboratories
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance 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.
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.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.3830
Treponema pallidum treponemal test reagents.(a)
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), theTreponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies toTreponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genusTreponema and provides epidemiological information on syphilis.(b)
Classification. Class II (performance standards).
0
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.
1
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.
2
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.
3
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 (770)488-7655.
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) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597 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
4
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:
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 | |
|---|---|
| 510(k) Number | K974810 |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use | |
|---|---|---|---|
| ------------------------------------------ | --------------------------------------------------------------------------------------------------------------------------------- | ---- | ---------------------- |
(Optional Format 1-2-96)