For use in monitoring the performance of the Vitros ECi Immunodiagnostic System when used for the in vitro qualitative detection of immunoglobulin G antibody to hepatitis C virus (anti-HCV) in human serum and plasma (heparin, EDTA or citrate). The performance of the Vitros Immunodiagnostic Products Anti-HCV Controls has not been established with any other anti-HCV assays.

Device Description

The Virros Immunodiagnostic System uses luminescence as the signal in the qualitative detection The Pirod Hillians are many plasma. Coated microwells are used as the solid phase separation system.

The system is comprised of three main elements:

The Viros Immunodiagnostic Products range of products, in this case Vitros Immunodiagnostic The / in of millians and Vitros Immunodiagnostic Products Calibrator, which are r routed by the Vitros Immunodiagnostic System to perform a Vitros assay. The Vitros Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator have been submitted for FDA review in PMA P010021.
The Vitros Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The Vitros Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919).
Common reagents used by the Vitros System in each assay. The Vitros Immunodiagnostic Products Signal Reagent and Vitros Immunodiagnostic Products Universal Wash Reagent were cleared as part of the Vitros Immunodiagnostic Products Total T3 510(k) pre-market notification (K964310).

The Vitros System and common reagents are dedicated specifically only for use with the Vitros Immunodiagnostic Products range of immunoassay products.

AI/ML Overview

The provided text describes a 510(k) summary for the Vitros Immunodiagnostic Products Anti-HCV Controls. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific performance acceptance criteria. Therefore, most of the requested information about acceptance criteria and study details are not available in the provided text.

Here is an analysis based on the available information:

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

The document does not explicitly state acceptance criteria or report specific device performance metrics in numerical terms that would typically be seen in a performance study. Instead, it focuses on comparing characteristics to a predicate device to establish substantial equivalence.

Table: Acceptance Criteria and Reported Device Performance (Based on provided text)

Characteristic/Criterion	Acceptance Criteria (Implicit)	Reported Device Performance (Summary of Comparison to Predicate)
Intended Use	Must be similar to or compatible with predicate.	Vitros controls: monitoring performance of Vitros ECi system for in vitro qualitative detection of anti-HCV in human serum/plasma. Predicate controls: estimate testing precision and detect errors for various analytes including anti-HCV; formulated for in vitro diagnostic kits.
Matrix of Controls	Must be similar to predicate for compatibility and appropriate control.	Vitros controls: Human serum with added antimicrobial agents. Predicate controls: Human serum or plasma with added stabilizers and preservative.
Control Levels Offered	Must offer relevant control levels (e.g., positive, negative)	Vitros controls: Positive and negative. Predicate controls: Positive (negative control available separately from BBI®).
Expected Values/Value Assignment	Must provide guidance on expected values for monitoring.	Vitros controls: Quoted mean value from ≥10 assays and standard deviation; values are lot specific. Predicate controls: No assigned values; formulated for positive reactivity; specific levels vary among assays/labs.
Substantial Equivalence	Demonstrate substantial equivalence to predicate device.	The pre-market notification demonstrates that the Vitros Anti-HCV Controls are substantially equivalent to the predicate device Boston Biomedica, Inc. ACCURUN 1® Multi-Marker Positive Control.

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

The document does not provide details on a "test set" in the context of a performance study with a specific sample size. The statement "Each control has a quoted mean value derived from a minimum of 10 assays" suggests some internal testing was performed, but this is not described as a formal validation study with a defined test set. Data provenance (country, retrospective/prospective) is not mentioned.

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 information is not provided because the document describes a regulatory submission for a control material, not a diagnostic device requiring expert interpretation for ground truth establishment.

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

Not applicable, as no external "test set" or adjudication requiring expert input is described in the provided text.

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 material for an immunoassay system, not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.

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

This concept is not relevant to the described device. The "device" is a control reagent for an automated immunoassay system, not an algorithm.

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

For control materials, the "ground truth" relates to the manufacturing specifications and known reactivity of the control. The document states that Vitros controls have "a quoted mean value derived from a minimum of 10 assays and a standard deviation," and "Values are lot specific." For the predicate, it's mentioned that controls "are formulated to produce positive reactivity." This implies that the ground truth for these controls is based on internal characterization and manufacturing processes to ensure they elicit expected responses within the intended assay. There is no external "ground truth" like pathology or expert consensus required for a control material in the same way it would be for a diagnostic test.

8. The sample size for the training set

Not applicable. This device is a control material, not a machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for this type of device.

Summary

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AUG 2 9 2001

Chapter 1 - Summary Information

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: K012561

1. Submitter name, address, contact

Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 (716) 453-4469

Contact Person: Susan Werner

Date 510(k) prepared: August 6, 2001

Device Name 2.

Trade or Proprietary Name: Vitros Immunodiagnostic Products Anti-HCV Controls Common Name: Anti-HCV controls Controll Name: 21CFR 862.1660 Quality Control Material (Assayed and Unassayed).

3. Predicate Device

I reducts be novels Anti-HCV Controls are substantially equivalent to Boston Biomedica, Inc. ACCURUN 1® Multi-Marker Positive Control (BK930027).

4. Device Description

The Virros Immunodiagnostic System uses luminescence as the signal in the qualitative detection The Pirod Hillians are many plasma. Coated microwells are used as the solid phase separation system.

The system is comprised of three main elements:

1. The Viros Immunodiagnostic Products range of products, in this case Vitros Immunodiagnostic The / in of millians and Vitros Immunodiagnostic Products Calibrator, which are r routed by the Vitros Immunodiagnostic System to perform a Vitros assay. The Vitros Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator have been submitted for FDA review in PMA P010021.
  3

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510(k) Summary, continued.

1. The Vitros Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The Vitros Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919).
1. Common reagents used by the Vitros System in each assay. The Vitros Immunodiagnostic Products Signal Reagent and Vitros Immunodiagnostic Products Universal Wash Reagent were cleared as part of the Vitros Immunodiagnostic Products Total T3 510(k) pre-market notification (K964310).

The Vitros System and common reagents are dedicated specifically only for use with the Vitros Immunodiagnostic Products range of immunoassay products.

5. Device Intended Use

The Vitros Anti-HCV Controls are intended for use in monitoring the performance of the Vitros ECi Immunodiagnostic System when used for the in vitro qualitative detection of immunoglobulin G antibody to hepatitis C virus (anti-HCV) in human serum and plasma (heparin, EDTA or citrate). The performance of the Vitros Immunodiagnostic Products Anti-HCV Controls has not been established with any other anti-HCV assays.

6. Comparison to Predicate Device

The Virros Immunodiagnostic Products Anti-HCV Controls are substantially equivalent to Boston Biomedica, Inc. ACCURUN 1® Multi-Marker Positive Control (BK930027).

Table 1 lists the similarities and differences of the device characteristics between the Vitros Anti-HCV Controls and the predicate device.

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Characteristics	New Device	Predicate Device
Intended use	For use in monitoring theperformance of the Vitros ECiImmunodiagnostic System whenused for the in vitro qualitativedetection of immunoglobulin Gantibody to hepatitis C virus(anti-HCV) in human serum andplasma (heparin, EDTA orcitrate). The performance of theVitros ImmunodiagnosticProducts Anti-HCV Controls hasnot been established with anyother anti-HCV assays.	ACCURUN 1® controls are intended toestimate laboratory testing precision andcan be used to detect errors in laboratorytesting procedures. ACCURUN 1® Multi-Marker Positive Controls have beenformulated for use with in vitro diagnostictest kits for the detection of antibodies toHuman Immunodeficiency Virus Types 1and 2 (HIV 1 and 2), antibodies to HumanT-Lymphotropic Virus Types I and II(HTLV I and II), antibodies to Hepatitis BCore Antigen (HBcAg), antibodies toHepatitis C Virus (HCV), antibodies toCytomegalovirus (CMV), and Hepatitis BSurface Antigen. A negative control forthese analytes is available separately fromBBI®.
Matrix of controls	Human serum with addedantimicrobial agents	Human serum or plasma with addedstabilizers and preservative.
Control levels	Positive and negative	Positive
Expected values	Each control has a quoted meanvalue derived from a minimum of10 assays and a standarddeviation anticipated for singledeterminations of each control ina number of different laboratoriesusing different reagent lots.Values are lot specific.	As stated in the package insert,ACCURUN 1® controls do not haveassigned values, but are formulated toproduce positive reactivity in the listedmanufacturer's assays. Specific levels ofreactivity will vary among differentmanufacturers' assays, differentprocedures, different reagent lot numbers,and different laboratories. Each laboratoryshould establish its own range ofacceptable values for each analyte.

7. Conclusions

The information presented in the pre-market notification demonstrates that the Vitros Anti-HCV Controls are substantially equivalent to the predicate device Boston Biomedica, Inc. ACCURUN 1® Multi-Marker Positive Control which was cleared by FDA (BK930027).

The information presented in the premarket notification provide a reasonable assurance that the Vitros Anti-HCV Controls are safe and effective for the stated intended use.

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Image /page/3/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 stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 2 9 2001

Ms. Susan Werner Regulatory Affairs Associate Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626-5101

K012561 Re:

Trade/Device Name: Vitros Immunodiagnostic Products Anti-HCV Controls Regulation Number: 21 CFR 862.1660 Regulatory Class: I Product Code: JJX, MJY, MJX Dated: August 6, 2001 Received: August 8, 2001

Dear Ms. Werner:

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 to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amerade over and 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 -

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 nothleadon. The I Dr I imailig of coation 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 v additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at additionally 007:10 for in This anglestions on the promotion and advertising of your device, (201) 594-4500. Radinomal), at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsibilities and its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/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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Statement of Intended Use

Page 1 of 1

K012561

510(k) Number (if known):

Device Name:

Vitros Immunodiagnostic Products Anti-HCV Controls

Indications for Use:

Woody Dubois

ision of Cimical Laboratory Devices, 01256 510(k) Number.

(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)

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.