ACCURUN™ 140 Rubella 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 Rubella virus. This control is not intended as a substitute for controls provided with test kits.

ACCURUN™ 140 control is intended to estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures.

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 Rubella virus in human serum and plasma.

Device Description

ACCURUN™ 140 Rubella IgG Positive Control is manufactured from human serum or plasma containing IgG antibodies to Rubella, 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™ 140 and all human blood.

This control is supplied as 1 x 1 ml vial or 1 x 5 ml vial. ACCURUN™ 140 should be stored at 2-8°C. Once opened, ACCURUN™ 140 should be discarded after 60 days.

AI/ML Overview

The provided document describes the ACCURUN™ 140 Rubella IgG Positive Control and its substantial equivalence determination, but it does not contain specific acceptance criteria or a study directly comparing reported device performance against numerical acceptance criteria in a table format.

The document focuses on:

Device description: Ingredients, storage, intended use.
Existing products and practices: States it's substantially equivalent to other commercial controls.
Summary of studies: Mentions stability studies (real-time, ambient temperature, heat stress, freeze-thaw, open vial) and clinical laboratory evaluations at BBI and two external labs.
Conclusions drawn from studies: Indicates the product is stable under various conditions and that "The clinical trial data demonstrate that ACCURUN™ 140 is safe and effective in three different laboratories with three manufactured ACCURUN™ 140 lots, and under various conditions of stress."

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance using the provided text. The document describes the types of studies conducted and their general conclusions but does not quantify performance metrics against pre-defined thresholds.

Here's a breakdown of what can be extracted or inferred from the document regarding the other points, along with what cannot be provided:

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

Not available in the provided text. The document states general conclusions about stability and effectiveness but does not present specific numerical acceptance criteria (e.g., "stability must be maintained within X% for Y days") or quantitative device performance data against such criteria.

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. The document mentions "clinical laboratory evaluations were performed at BBI and at two clinical laboratories" and that "three manufactured ACCURUN™ 140 lots" were used. It refers to "clinical trial data" but doesn't quantify the number of tests, specimens, or specific patient samples in these evaluations.
Data provenance: While the sponsor, Boston Biomedica, Inc., is based in West Bridgewater, MA, USA, the specific country of origin for the clinical evaluation data is not mentioned, other than being conducted at BBI and "two clinical laboratories" (location unspecified). The studies appear to be prospective for the purpose of demonstrating stability and performance for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not available. This device is a positive control, not a diagnostic device that interprets clinical findings. Its "ground truth" is its known positive status for Rubella IgG antibodies. Ground truth in the context of expert review for diagnostic interpretation isn't relevant here. The clinical evaluations would have assessed its consistency and performance in detecting Rubella IgG in test systems, not its ability to diagnose a patient.

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

Not applicable/Not available. As a control, adjudication of results in the traditional sense of resolving discrepancies in diagnoses is not relevant. The performance was likely assessed through consistency and expected reactivity in various Rubella IgG 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 device is a control, not an AI-powered diagnostic tool. Therefore, MRMC studies and "human readers improve with AI" are not relevant to this product.

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

Not applicable. This is a human-blood-based laboratory control, not an algorithm or AI device.

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

The "ground truth" for this positive control is its inherent positivity for Rubella IgG antibodies, manufactured from human serum or plasma containing these antibodies. This is established during its manufacturing and characterization rather than through expert consensus, pathology, or outcomes data in the context of patient diagnosis. Its performance is then evaluated by testing its reactivity in Rubella IgG assays.

8. The sample size for the training set

Not applicable. This is a biological control, not a machine learning or AI device that uses a "training set."

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

Not applicable. See point 8.

Summary

{0}------------------------------------------------

ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ

11 11 12 4

Boston Biomedica, Inc. 510(k) Notification ACCURUN™ 140 Rubella IgG Positive Control

SUMMARY OF SAFETY AND EFFECTIVENESS FOR

Boston Biomedica, Inc.'s

ACCURUN™ 140

Reference No:

Product Name: ACCURUN™ 140 Rubella IgG Positive Control

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

Indications for use 1.

ACCURUN™ 140 control is intended to estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures.

2. Device description

ﺮ

{1}------------------------------------------------

This control is supplied as 1 x 1 ml vial or 1 x 5 ml vial. ACCURUN™ 140 should be stored at 2-8°C. Once opened, ACCURUN™ 140 should be discarded after 60 days.

Existing products and practices 3.

Controls of the type represented by Boston Biomedica's ACCURUN™ 140 Rubella 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™ 140 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™ 140 Rubella 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™ 140 as an independent run control in situations where it is most likely to be used.

Conclusions drawn from studies 5.

We have performed extensive testing to determine the stability of ACCURUN™ 140 Rubella IgG Positive Control under various environmental and user conditions. The data suggest that ACCURUN™ 140 can be stored at 2-8°C in its vialed form and is not affected by multiple freeze-thaw cycles. ACCURUN™ 140 is stable at ambient temperatures and under heat stress for a short period of time with no adverse effects. ACCURUN™ 140 remains stable even after the vials have been repeatedly opened and stored at 2-8ºC for at least 60 days.

The clinical trial data demonstrate that ACCURUN™ 140 is safe and effective in three different laboratories with three manufactured ACCURUN™ 140 lots, and under various conditions of stress.

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services (HHS). The seal features a stylized eagle with three overlapping profiles facing right, representing health, human services, and the public. The text "DEPARTMENT OF HEALTH & HU. AN SERVICES USA" is arranged in a circular pattern around the eagle.

OCT - 8 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K972986

Trade Name: ACCURUN™ 140 Rubella IgG Positive Control Regulatory Class: I Product Code: MJX Dated: August 8, 1997 Received: August 11, 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 Sutman

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™ 140 Rubella IgG Positive Control

Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):

Device Name: ACCURUN™ 140 Rubella IgG Positive Control

Indications For Use:

Boston Biomedica intends to manufacture and market ACCURUN™ 140 Rubella IgG Positive Control, which 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 Rubella virus. This control is not intended as a substitute for controls provided with test kits.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Seana Cooper
(Division Sign-Off)

Division of Clinical Laboratory Devices 510(k) Number_K 972986

Prescription Use し (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.