(44 days)
No
The device is a positive control for laboratory tests and does not involve any data processing or algorithmic analysis.
No.
This device is an in vitro diagnostic control used to estimate laboratory testing precision and detect errors in testing procedures for the detection of IgG antibodies to Borrelia burgdorferi; it is not used to treat, prevent, or diagnose a condition in a patient.
No
This device is described as an "independent run control" for in vitro diagnostic tests, not a diagnostic device itself. Its purpose is to estimate laboratory testing precision and detect errors in testing procedures for other diagnostic tests, not to diagnose a condition.
No
The device is a physical control material (human blood-based) used in laboratory testing, not a software application.
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 IgG antibodies to Borrelia burgdorferi (Lyme Disease)." This indicates it is used in vitro (outside the body) to evaluate the performance of diagnostic tests.
- Device Description: It is manufactured from human serum or plasma and contains antibodies, which are biological components used in diagnostic testing.
- Target User and Setting: It is intended for "clinical laboratory professionals in public health laboratories and clinical laboratories," which are settings where in vitro diagnostic testing is performed.
- Purpose: The purpose is to "estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures." This is a key function of a control material used in IVD testing.
- Use with IVD Tests: The description explicitly states it is for use "with in vitro diagnostic tests for the detection of IgG antibodies to Borrelia burgdorferi in human serum."
Based on these points, the ACCURUN™ 130 Borrelia burgdorferi IgG Positive Control fits the definition of an In Vitro Diagnostic device. It is a reagent or material used in a laboratory setting to assess the performance of diagnostic tests that are performed in vitro.
N/A
Intended Use / Indications for Use
ACCURUN™ 130 Borrelia burgdorferi 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 Borrelia burgdorferi (Lyme Disease). This control is not intended as a substitute for controls provided with test kits.
ACCURUN™ 130 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™ 130 Borrelia burgdorferi 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 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 IgG antibodies to Borrelia burgdorferi in human serum.
Product codes
LSR
Device Description
ACCURUN™ 130 Borrelia burgdorferi IgG Positive Control is manufactured from human serum or plasma containing IgG 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™ 130 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 Borrelia burgdorferi in human serum.
This control is supplied as 1 x 1 ml vial. ACCURUN™ 130 should be stored at 2-8°C. Once opened. ACCURUN™ 130 should be discarded after 60 days.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratory professionals in public health laboratories and clinical laboratories for use with in vitro diagnostic tests for the detection of IgG antibodies to Borrelia burgdorferi in human serum.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
BBI performed five types of stability studies to support the labeling and storage conditions for ACCURUN™ 130 Borrelia burgdorferi 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, one blood bank and one clinical laboratory. The data provided by these external laboratories were collected to evaluate the consistency and performance of ACCURUN™ 130 as an independent run control in situations where it is most likely to be used.
Conclusions drawn from studies: We have performed extensive testing to determine the stability of ACCURUN™ 130 Borrelia burgdorferi IgG Positive Control under various environmental and user conditions. The data suggest that ACCURUN™ 130 can be stored at 2-8°C in its vialed form and is not affected by multiple freeze-thaw cycles. ACCURUN™ 130 is stable at ambient temperatures and under heat stress for a short period of time with no adverse effects. ACCURUN™ 130 remains stable even after the vials have been repeatedly opened and stored at 2-8°C for at least 60 days.
The clinical trial data demonstrate that ACCURUN™ 130 is safe and effective in three different laboratories with three manufactured ACCURUN™ 130 lots, and under various conditions of stress.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ACCURUN™ 130 is substantially equivalent to other commercially available unassayed, single analyte and multi-analyte independent run controls. K974809
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 910(K) Nonneation
ACCURUN™ 130 Borrelia burgdorferi IgG Positive Control
FEB - 5 1998
SUMMARY OF SAFETY AND EFFECTIVENESS
Boston Biomedica, Inc.'s
ACCURUN™ 130
Reference No:
Product Name: ACCURUN™ 130 Borrelia burgdorferi IgG Positive Control
Boston Biomedica, Inc. Sponsor: 375 West Street West Bridgewater, MA 02379
1. Indications for use
ACCURUN™ 130 Borrelia burgdorferi 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 Borrelia burgdorferi (Lyme Disease). This control is not intended as a substitute for controls provided with test kits.
ACCURUN™ 130 control is intended to estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures.
2. Device description
ACCURUN™ 130 Borrelia burgdorferi IgG Positive Control is manufactured from human serum or plasma containing IgG 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™ 130 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 Borrelia burgdorferi in human serum.
This control is supplied as 1 x 1 ml vial. ACCURUN™ 130 should be stored at 2-8°C. Once opened. ACCURUN™ 130 should be discarded after 60 days.
1
Existing products and practices 3.
Controls of the type represented by Boston Biomedica's ACCURUN™ 130 Borrelia burgdorferi 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™ 130 is substantially equivalent to other commercially available unassayed, 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™ 130 Borrelia burgdorferi 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, one blood bank and one clinical laboratory. The data provided by these external laboratories were collected to evaluate the consistency and performance of ACCURUN™ 130 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™ 130 Borrelia burgdorferi IgG Positive Control under various environmental and user conditions. The data suggest that ACCURUN™ 130 can be stored at 2-8°C in its vialed form and is not affected by multiple freeze-thaw cycles. ACCURUN™ 130 is stable at ambient temperatures and under heat stress for a short period of time with no adverse effects. ACCURUN™ 130 remains stable even after the vials have been repeatedly opened and stored at 2-8°C for at least 60 days.
The clinical trial data demonstrate that ACCURUN™ 130 is safe and effective in three different laboratories with three manufactured ACCURUN™ 130 lots, and under various conditions of stress.
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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 with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
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: K974809
Trade Name: ACCURUN™ 130 Borrelia burgdorferi IgG 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 (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 vour 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 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
4
Boston Biomedica, Inc. 510(k) Notification ACCURUN™ 130 Borrelia burgdorferi IgG Positive Control
Page Page Ca of
510(k) Number (if known):
Device Name: ACCURUN™ 130 Borrelia burgdorferi IgG Positive Control
Indications For Use:
Boston Biomedica intends to manufacture and market ACCURUN™ 130 Borrelia burgdorferi 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 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 IgG 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)
Flo Hom
(Division Sign-Off)
Division of Clinical Laboratory Devices
| 510(k) Number | K974809 |
|---|---|
| --------------- | --------- |
| Prescription Use (Per 21 CFR 801.109 | ✓ |
|---|---|
| -------------------------------------- | ---------------------------------------------------- |
OR
| Over-The-Counter Use | ____________________ |
|---|---|
| ---------------------- | ---------------------- |
(Optional Format 1-2-96)
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