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.

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 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.

AI/ML Overview

The provided document is a 510(k) notification for the ACCURUN™ 130 Borrelia burgdorferi IgG Positive Control. This device is a control for laboratory tests, not a diagnostic device that directly measures a patient's condition. As such, the concept of "acceptance criteria" and "device performance" in the traditional sense (e.g., sensitivity, specificity for a diagnostic test) does not directly apply.

Instead, the "acceptance criteria" for a control device relate to its stability and consistency to ensure it performs reliably as a positive control over time and under various conditions. The "study that proves the device meets the acceptance criteria" refers to the stability studies and clinical laboratory evaluations performed by Boston Biomedica, Inc.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria in a table format. However, it describes the goals of the stability studies, which can be interpreted as the implicit acceptance criteria for a control device: that it remains stable and functions correctly as a positive control. The reported performance is the conclusion that these criteria were met.

Acceptance Criteria (Implicit)	Reported Device Performance
Stability at 2-8°C (stored in vialed form): The control should maintain its intended reactivity as a positive control for its stated shelf-life.	"The data suggest that ACCURUN™ 130 can be stored at 2-8°C in its vialed form..."
Stability after multiple freeze-thaw cycles: The control should maintain its intended reactivity.	"...and is not affected by multiple freeze-thaw cycles."
Stability at ambient temperatures (short period): The control should maintain its intended reactivity.	"ACCURUN™ 130 is stable at ambient temperatures... for a short period of time with no adverse effects."
Stability under heat stress (short period): The control should maintain its intended reactivity.	"...and under heat stress for a short period of time with no adverse effects."
Open vial stability (2-8°C): The control should maintain its intended reactivity for the stated open-vial duration.	"ACCURUN™ 130 remains stable even after the vials have been repeatedly opened and stored at 2-8°C for at least 60 days."
Consistency and performance as an independent run control: The device should consistently perform as a reliable positive control in various laboratory settings and with different manufacturing lots.	"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." "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."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not explicitly stated as a single number. The studies included:
- "five types of stability studies" (real time, ambient temperature, heat stress, freeze-thaw, open vial).
- "clinical laboratory evaluations... at BBI, one blood bank and one clinical laboratory."
- These evaluations involved "three manufactured ACCURUN™ 130 lots."
Data Provenance: The studies were performed by Boston Biomedica, Inc. (BBI) and "one blood bank and one clinical laboratory." The location of these external labs is not specified, but BBI is located in West Bridgewater, MA, USA, suggesting the studies were likely conducted in the USA.
Retrospective or Prospective: The studies appear to be prospective as they involved testing the device under specific conditions (stability studies) and in real-world clinical laboratory evaluations to observe its performance over time.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This question is not applicable in the typical sense for a control device.

The "ground truth" for the ACCURUN™ 130 is its known status as a "Borrelia burgdorferi IgG Positive Control," meaning it is intended to test positive for IgG antibodies to Borrelia burgdorferi.
The "experts" involved are the laboratory personnel in the "one blood bank and one clinical laboratory" who performed the evaluations using existing in vitro diagnostic tests. Their specific qualifications (e.g., years of experience) are not provided, but they are implied to be "clinical laboratory professionals."

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. The studies evaluated the control's performance as a positive control, primarily its stability and consistency in producing a positive result with Borrelia burgdorferi IgG tests. There isn't a "ground truth" that needs adjudication by multiple experts in the way a diagnostic image or clinical case might. The assessment would have been based on the expected positive reactivity in assays.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted diagnostic device or a device where human reader performance is being evaluated or improved. It is a laboratory control.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm-based device. It is a biological control material.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for ACCURUN™ 130 is its intended function as a positive control for IgG antibodies to Borrelia burgdorferi. This is established by its manufacturing and purification process, ensuring it contains detectable levels of these antibodies. The studies aimed to confirm that this inherent "positive" characteristic (its ground truth) remained consistent and stable over time and under various conditions when tested with standard Borrelia burgdorferi IgG assays.

8. The sample size for the training set

Not applicable. As a control device, there isn't a "training set" in the machine learning sense. The device is manufactured to a specific specification. The "studies" are more akin to validation and verification of its performance and stability.

9. How the ground truth for the training set was established

Not applicable, as there is no training set. The "ground truth" (its positive status) is inherent in the design and manufacturing of the control, derived from human serum or plasma known to contain IgG antibodies to Borrelia burgdorferi.

Summary

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

2. Device description

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.

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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

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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:

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

Regulation Number and Section

§ 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).