ACCURUN™ 146 CMV 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 Cytomegalovirus (CMV). This control is not intended as a substitute for controls provided with test kits. ACCURUN™ 146 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 IgM antibodies to CMV in human serum and plasma.

Device Description

ACCURUN™ 146 CMV IgM Positive Control is manufactured from human serum or plasma containing IgM antibodies to CMV, but is nonreactive for Hepatitis B Surface Antigen (HBsAg) and 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. This control is supplied as 1 x 1 ml or 1 x 5 ml vial. ACCURUN™ 146 should be stored frozen at -10°C or colder. Once opened, ACCURUN™ 146 should be stored at 2-8°C and discarded after 60 days.

AI/ML Overview

The provided document describes the ACCURUN™ 146 CMV IgM Positive Control, a human blood-based single analyte run control for detecting IgM antibodies to Cytomegalovirus (CMV). However, it does not explicitly state acceptance criteria in a quantitative manner or provide a detailed study report with performance metrics against pre-defined criteria.

Based on the available text, here's a breakdown of the information and what cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Inferred)	Reported Device Performance
Stability:
- Real-time stability	Stable when stored frozen (-10°C or colder).
- Ambient temperature stability	Stable for a short period of time.
- Heat stress stability	Stable for a short period of time with no adverse effects.
- Freeze-thaw stability	Not affected by multiple freeze-thaw cycles.
- Open vial stability	Stable for at least 60 days when stored at 2-8°C after opening.
Safety and Effectiveness:	Safe and effective as an independent run control.
Batch Consistency:	Demonstrated consistency across three manufactured lots.
Performance in varied lab conditions:	Effective in three different laboratories under various conditions of stress.

Important Note: The document describes the types of stability studies performed and the conclusions drawn, but lacks specific quantitative acceptance criteria (e.g., "signal not to drop by more than X% after Y days at Z temperature"). The "reported device performance" is a summary of the conclusions rather than hard data points.

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

Sample Size for Test Set: Not explicitly stated. The document mentions "clinical laboratory evaluations were performed at BBI and two external sites, including one blood bank and a clinical laboratory" and "three manufactured ACCURUN™ 146 lots." However, the number of individual control vials or test events in these evaluations is not provided.
Data Provenance: The studies were conducted at "BBI and two external sites, including one blood bank and a clinical laboratory." The countries of origin for these labs are not specified. The studies appear to be prospective evaluations of the device's stability and performance in a usability context.

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

Not applicable. This device is a positive control, meaning its purpose is to provide a known positive signal for CMV IgM. It does not output a diagnostic result that requires expert interpretation or ground truth establishment in the traditional sense of a diagnostic test. The "ground truth" for the control itself is its known composition (human serum/plasma containing IgM antibodies to CMV). The evaluations focused on the control's stability and consistency in producing an expected signal, not on its diagnostic accuracy against patient samples.

4. Adjudication Method for the Test Set:

Not applicable. There was no "test set" in terms of patient samples requiring diagnostic interpretation and adjudication. The studies evaluated the stability and performance of the control itself.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This type of study is not applicable to a positive control device. MRMC studies are typically performed for diagnostic devices where human readers interpret medical images or data, and the comparison is between human performance with and without AI assistance. The ACCURUN™ 146 is a control material, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This device is a biological control material, not an algorithm.

7. Type of Ground Truth Used:

For the composition of the control itself, the ground truth is the known presence of IgM antibodies to Cytomegalovirus (CMV) in the human serum or plasma used to manufacture it, along with confirmed non-reactivity for other specified viruses (HBsAg, HIV 1/2, HTLV I, HCV). The studies assessed the control's ability to maintain its intended characteristics (stability, consistent signal) over time and under various conditions.

8. Sample Size for the Training Set:

Not applicable. This device is a biochemical control, not an AI model that requires a training set.

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

Not applicable. As above, no training set is relevant for this product.

Summary

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

K972884
AUG 22 1997

Boston Biomedica Inc. 510(k) Notification ACCURUN™ 146 CMV IgM Positive Control

SUMMARY OF SAFETY AND EFFECTIVENESS FOR

Boston Biomedica, Inc.'s

ACCURUN™ 146

Reference No:

Product Name: ACCURUN™ 146 CMV IgM Positive Control

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

Indications for use 1.

ACCURUN™ 146 control is intended to estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures.

Device description 2.

ACCURUN™ 146 CMV IgM Positive Control is manufactured from human serum or plasma containing IgM antibodies to CMV, but is nonreactive for Hepatitis B Surface Antigen (HBsAg) and 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™ 146 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 CMV in human serum and plasma.

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

This control is supplied as 1 x 1 ml or 1 x 5 ml vial. ACCURUN™ 146 should be stored frozen at -10°C or colder. Once opened, ACCURUN™ 146 should be stored at 2-8°C and discarded after 60 days.

Existing products and practices 3.

Controls of the type represented by Boston Biomedica's ACCURUN™ 146 CMV 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™ 146 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™ 146 CMV 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 and two external sites, including one blood bank and a clinical laboratory. The data provided by these external laboratories were collected to evaluate the consistency and performance of ACCURUN™ 146 as an independent run control in situations where it is most likely to be used.

Conclusions drawn from studies ડ.

We have performed extensive testing to determine the stability of ACCURUN™ 146 CMV IgM Positive Control under various environmental and user conditions. The data suggest that ACCURUN™ 146 can be stored frozen in its vialed form (-10°C or colder) and is not affected by multiple freeze-thaw cycles. ACCURUN™ 146 is stable at ambient temperatures and under heat stress for a short period of time with no adverse effects. ACCURUN™ 146 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™ 146 is safe and effective in three different laboratories with three manufactured ACCURUN™ 146 lots, and under various conditions of stress.

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

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion. The seal is presented in black and white.

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

AUG 22 1997

Re: K972884

Trade Name: ACCURUN™ 146 CMV IgM Positive Control Regulatory Class: II Product Code: LKQ Dated: August 4, 1997 Received: August 5, 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.

{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™ 146 CMV IgM Posítive Control

Page

510(k) Number (if known):

ACCURUN™ 146 CMV IgM Positive Control Device Name:_

Indications For Use:

Boston Biomedica intends to manufacture and market ACCURUN™ 146 CMV IgM 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 IgM antibodies to Cytomegalovirus (CMV). 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)

Ola P

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K972884

Image /page/4/Picture/11 description: The image shows the words "Prescription Use" in a sans-serif font. Below this, the text "(Per 21 CFR 801.109)" is printed. A check mark is placed above the word "Use".

Over-The-Counter Use -

(Optional Format 1-2-96)

Regulation Number and Section

§ 866.3175 Cytomegalovirus serological reagents.

(a)
Identification. Cytomegalovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to cytomegalovirus in serum. The identification aids in the diagnosis of diseases caused by cytomegaloviruses (principally cytomegalic inclusion disease) and provides epidemiological information on these diseases. Cytomegalic inclusion disease is a generalized infection of infants and is caused by intrauterine or early postnatal infection with the virus. The disease may cause severe congenital abnormalities, such as microcephaly (abnormal smallness of the head), motor disability, and mental retardation. Cytomegalovirus infection has also been associated with acquired hemolytic anemia, acute and chronic hepatitis, and an infectious mononucleosis-like syndrome.(b)
Classification. Class II (performance standards).