ACCURUN™ 150 HSV 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 herpes simplex virus (HSV). This control is not intended as a substitute for controls provided with test kits.

ACCURUN™ 150 control is intended to estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures.

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 HSV in human serum.

Device Description

ACCURUN™ 150 HSV IgG Positive Control is manufactured from human serum or plasma containing IgG antibodies to herpes simplex virus, 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™ 150 and all human blood.

This control is supplied as 1 x 1 ml vial and 1 x 5 ml vial. ACCURUN™ 150 should be stored at 2-8°C. Once opened, ACCURUN™ 150 should be discarded after 60 days.

AI/ML Overview

Here's an analysis of the provided text regarding the ACCURUN™ 150 HSV IgG Positive Control, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a control product, not a diagnostic device that measures a specific outcome. Therefore, the "acceptance criteria" and "device performance" are focused on the control's stability and its ability to consistently perform in laboratory settings using existing IgG antibody detection tests.

Acceptance Criteria	Reported Device Performance
Stability at 2-8°C	"ACCURUN™ 150 can be stored at 2-8°C in its vialed form..."
Stability to Multiple Freeze-Thaw Cycles	"...is not affected by multiple freeze-thaw cycles."
Stability at Ambient Temperatures	"ACCURUN™ 150 is stable at ambient temperatures... for a short period of time with no adverse effects."
Stability under Heat Stress	"ACCURUN™ 150... under heat stress for a short period of time with no adverse effects."
Open Vial Stability (at 2-8°C)	"ACCURUN™ 150 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 clinical trial data demonstrate that ACCURUN™ 150 is safe and effective in three different laboratories with three manufactured ACCURUN™ 150 lots, and under various conditions of stress."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated as a number of individual samples. The study involved "three different laboratories with three manufactured ACCURUN™ 150 lots." The data was collected through "clinical laboratory evaluations" performed at BBI (Boston Biomedica, Inc.) and at "two clinical laboratories."
Data Provenance: Retrospective, as the study was completed to support the 510(k) submission. The country of origin is not explicitly stated, but given that Boston Biomedica, Inc. is a U.S.-based company and the FDA approval is for marketing in the U.S., it can be inferred the data largely originated from the United States.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The "ground truth" for a control material like this isn't typically established by expert consensus in the same way a diagnostic test is. Instead, it relies on the intrinsic properties of the control material (presence of IgG antibodies to HSV) and its consistent behavior when tested by standard HSV IgG assays.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of a control material study, a formal adjudication method for ground truth in the sense of a diagnostic outcome is unlikely to have been applied. The "evaluation" would likely involve assessing the consistency of results obtained when the control was run through various HSV IgG tests.

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

No, an MRMC comparative effectiveness study was not done. This product is a positive control for detecting HSV IgG antibodies, not an AI-powered diagnostic device, and therefore does not involve human readers or AI assistance in its function.

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

No, a standalone algorithm performance study was not done. Again, this product is a biological control material, not an algorithm. Its performance is evaluated by its consistency when used with existing diagnostic tests.

7. The Type of Ground Truth Used

The "ground truth" for this control is its known composition: it is "manufactured from human serum or plasma containing IgG antibodies to herpes simplex virus." The performance evaluation confirms that this known positive status is consistently detected by various HSV IgG tests and that the control remains stable under different conditions. It's essentially a known positive sample used to verify the proper functioning of other diagnostic tests.

8. The Sample Size for the Training Set

This product is not an AI algorithm and therefore does not have a "training set" in the conventional sense. Its development involved sourcing human serum/plasma with specific antibodies and then formulating it with stabilizers and preservatives. The stability studies and clinical laboratory evaluations served as validation, not training.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of product. The "ground truth" (the presence of HSV IgG antibodies) in the source material would have been established using validated, commercially available HSV IgG detection assays at the time of sourcing.

Summary

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4911

Boston Biomedica, Inc. 510(k) Notification ACCURUN™ 150 HSV IgG Positive Control

Reference No:

FEB | 0 1998

SUMMARY OF SAFETY AND EFFECTIVENESS

Boston Biomedica, Inc.'s

ACCURUN™ 150

Product Name: ACCURUN™ 150 HSV IgG Positive Control

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

Indications for use 1.

ACCURUN™ 150 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 and 1 x 5 ml vial. ACCURUN™ 150 should be stored at 2-8°C. Once opened, ACCURUN™ 150 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™ 150 HSV 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™ 150 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™ 150 HSV 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™ 150 as an independent run control in situations where it is most likely to be used.

న. Conclusions drawn from studies

We have performed extensive testing to determine the stability of ACCURUN™ 150 HSV IgG Positive Control under various environmental and user conditions. The data suggest that ACCURUN™ 150 can be stored at 2-8°C in its vialed form and is not affected by multiple freeze-thaw cycles. ACCURUN™ 150 is stable at ambient temperatures and under heat stress for a short period of time with no adverse effects. ACCURUN™ 150 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™ 150 is safe and effective in three different laboratories with three manufactured ACCURUN™ 150 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 and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, which is a traditional symbol of medicine.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 1 0 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: K974811

Trade Name: ACCURUN™ 150 HSV IgG Positive Control Regulatory Class: I Product Code: JJX 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 requirements, as set forth in the Quality System Regulation (OS) 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 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

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Boston Biomodica, Inc. 510(k) Notification ACCURUN™ 150 HSV IgG Positive Control

of Page

510(k) Number (if known):____ K 9 7 4 8 11

Device Name: ACCURUN™ 150 HSV IgG Positive Control

Indications For Use:

Boston Biomedica intends to manufacture and market ACCURUN™ 150 HSV 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 herpes simplex virus (HSV). 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.

(PI.F.ASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

	Sally L. Slepah acting for Flo Houn (Division Sign-Off) Division of Clinical Laboratory Devices
510(k) Number	K974811

Prescription Use (Per 21 CFR 801.109	✓	OR	Over-The-Counter Use
--------------------------------------	-----------------------------	----	----------------------

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.