The Vitros Immunodiagnostic Products Anti-HBc IgM Controls are intended for use in monitoring the performance of the Vitros ECi Immunodiagnostic System when used for the in vitro qualitative detection of IgM antibody to Hepatitis B core antigen (anti-HBc IgM) in human serum and plasma (heparin, EDTA or citrate). For in vitro diagnostic use.

Device Description

The Vitros Immunodiagnostic Products Anti-HBc IgM Controls are comprised of two levels of controls in separate vials: Control 1 (Negative) and Control 2 (Positive). Control 1 is normal human plasma obtained from donors tested negative for hepatitis B surface antigen, and for antibodies to human immunodeficiency virus (HIV 1+2) and hepatitis C virus (HCV) using FDA approved methods (enzyme immunoassays, EIA). Control 2 is normal human plasma spiked with anti-HBc IgM positive plasma, obtained from donors tested negative for antibodies to human immunodeficiency virus (HIV 1+2) and hepatitis C virus (HCV) using FDA approved methods (EIA). Both controls contain antimicrobial agent and are freeze-dried. The controls are assigned values from a minimum of 10 assays.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Vitros Immunodiagnostic Products Anti-HBc IgM Controls:

The provided document is a 510(k) summary for a Quality Control Material (Assayed and Unassayed), not a diagnostic device that performs a diagnosis or screening. Therefore, some of the requested information (like multi-reader multi-case studies, effect size, standalone performance, and extensive ground truth details for a training set of an AI model) are not applicable to this type of medical device submission.

The "acceptance criteria" for a control material like this are primarily related to its performance in monitoring a diagnostic system, rather than diagnostic accuracy itself. The study described focuses on demonstrating substantial equivalence to a predicate device and showing the control material behaves as expected.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document describes the formulation and intended use of the controls, and states they are "substantially equivalent" to a predicate, rather than providing explicit numeric acceptance criteria and detailed performance results from a specific study. The acceptance criteria for the control material itself would typically involve its stability, consistency, and ability to produce expected results (e.g., positive control yields a positive result, negative control yields a negative result) when run on the target diagnostic system.

Acceptance Criteria (Implied)	Reported Device Performance
Control 1 (Negative):	Normal human plasma, negative for various markers by FDA approved methods.
- Should consistently produce a negative result on the target system.	(Implicit in device description)
Control 2 (Positive):	Normal human plasma spiked with anti-HBc IgM positive plasma.
- Should consistently produce a positive result on the target system.	(Implicit in device description)
Antimicrobial agent present:	Yes, present.
Freeze-dried:	Yes, freeze-dried.
Substantial Equivalence:	Determined to be substantially equivalent to Blackhawk BioSystems, Inc Virotrol III (K974613).
Monitoring performance of Vitros ECi Immunodiagnostic System:	Intended for this use.
Assigned values from a minimum of 10 assays:	Values are assigned this way.
Standard deviation as anticipated for single determinations:	Yes, standard deviation is described as such.

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

Sample Size for Test Set: Not explicitly stated as a separate "test set" in the context of diagnostic accuracy for a patient population. For controls, the "testing" involves verifying the control's properties. The document mentions "a minimum of 10 assays" used to assign values to the controls, implying that each control level (positive and negative) was run at least 10 times to establish its expected range/value.
Data Provenance: The plasma components for the controls are described as "Normal human plasma obtained from donors."
- Country of Origin: Not specified.
- Retrospective or Prospective: Not specified, but given the nature of control material manufacturing, it would be a controlled, prospective process of sourcing, processing, and testing materials.

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

This information is not applicable in the context of an AI device's performance study. For this control material:

The "ground truth" for the individual components of the controls (e.g., negative for certain markers, positive for anti-HBc IgM) was established by using "FDA approved methods (enzyme immunoassays, EIA)".
There were no "experts" in the sense of radiologists or clinical specialists interpreting images or complex patient data to establish ground truth for the control material itself. The determination of negativity or positivity of the source plasma was based on standard laboratory test results.

4. Adjudication Method for the Test Set

Not applicable. There was no complex subjective assessment of patient data requiring adjudication. The assessment of the source plasma was based on objective laboratory test results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that an AI algorithm assists human readers in interpreting (e.g., medical images). The Vitros Immunodiagnostic Products Anti-HBc IgM Controls are quality control materials, not diagnostic algorithms, and therefore do not involve human readers interpreting patient cases with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

Not applicable. This device is a quality control material, not an algorithm. Its "performance" is its ability to consistently provide a known positive or negative signal on a specific diagnostic system (the Vitros ECi Immunodiagnostic System), allowing laboratories to monitor the system's performance.

7. The Type of Ground Truth Used

For the source material (plasma) used to create the controls: Laboratory test results using "FDA approved methods (enzyme immunoassays, EIA)" to determine the presence or absence of specific markers (e.g., hepatitis B surface antigen, antibodies to HIV 1+2, HCV, and anti-HBc IgM).
For the control material itself: Its "ground truth" is its assigned value/category (positive or negative) established through a minimum of 10 assays, which then serves as a known standard for verifying the performance of the Vitros ECi system.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm and does not have a "training set" in the conventional sense.

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

Not applicable. (See point 8).

Summary

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GENERAL INFORMATION 2.0

OCT 3 1 2003

2.1 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K032993

2.1.1 Submitter Name, Address, Contact

Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 (585) 453-3154

Contact Person: Sarah Parsons

Preparation Date 2.1.2

Date 510(k) Summary Prepared:

2.1.3 Device Name

Trade or Proprietary Name: Vitros Immunodiagnostic Products Anti-HBc IgM Controls

Anti-HBc IgM Controls Common Name:

Classification Name: 21CFR 862.1660 Quality Control Material (Assayed and Unassayed).

Predicate Device 2.1.4

The Vitros Immunodiagnostic Products Anti-HBc IgM Controls are substantially equivalent to Blackhawk BioSystems, Inc Virotrol III (K974613).

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Device Description 2.1.5

The Vitros Immunodiagnostic Products Anti-HBc IgM Controls are comprised of two levels of controls in separate vials:

Control 1 (Negative)

Normal human plasma obtained from donors who were tested individually and found to be negative for hepatitis B surface antigen, and for antibodies to human immunodeficiency virus (HIV 1+2) and hepatitis C virus (HCV) using FDA approved methods (enzyme immunoassays, EIA).

Control 2 (Positive)

Normal human plasma spiked with anti-HBc IgM positive plasma. The positive plasma was obtained from donors who were tested individually and found to be negative for antibodies to human immunodeficiency virus (HIV 1+2) and hepatitis C virus (HCV) using FDA approved methods (EIA).

Both controls contain antimicrobial agent and are freeze-dried.

The controls are assigned values from a minimum of 10 assays. The standard deviation is that which would be anticipated for single determinations of each control in a number of different laboratories using different reagent batches.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 31 2003

Ms. Sarah Parsons Associate, Regulatory Affairs Ortho Clinical Diagnostics 100 Indigo Creek Park Rochester, NY 14626-5101

Re: K032993

Trade/Device Name: Vitros Immunodiagnostic Products Anti-HBc IgM Controls Regulation Number: 21 CFR 866.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I Product Code: JJX Dated: September 24, 2003 Received: September 25, 2003

Dear Ms. Parsons:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 misb. anding and adulteration.

If vour device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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2.2 Indications for Use Statement

Page 1 of 1

Ko32993 510(k) Number (if known):

Device Name:

Vitros Immunodiagnostic Products Anti-HBc IgM Controls

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)
------------------------------------------	---------------

OR	Over-The-Counter Use
Division Sign-Off	(Optional Format 1-2-96)

Office of In Vitro Diagnostic Device
Evaluation and Safety

510(k)	K032993
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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.