The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum, plasma and urine. Coated microwells are used as the solid phase separation system. The system is comprised of three main elements: 1. The VITROS Immunodiagnostic Products range of products, in this case VITROS Immunodiagnostic Products Reagent Pack, VITROS Immunodiagnostic Products Calibrators which are combined by the VITROS Immunodiagnostic System to perform a VITROS assay. 2. The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. 3. Common reagents used by the VITROS System in each assay. The VITROS System and common reagents are dedicated specifically only for use with the VITROS Immunodiagnostic Products range of immunoassay products. The VITROS Oncology Controls are intended for in vitro use in monitoring the performance of the VITROS Immunodiagnostic System when used for the measurement of selected analytes.

AI/ML Overview

The provided text describes a 510(k) summary for the "VITROS Immunodiagnostic Products Oncology Controls." However, it focuses on demonstrating substantial equivalence to a predicate device rather than detailing a study with specific acceptance criteria and performance metrics of the new device itself.

Therefore, much of the requested information regarding acceptance criteria, specific device performance, sample sizes for test and training sets, ground truth establishment, and details of clinical studies (like MRMC or standalone) is not present in the provided document.

Here's the information that can be extracted or inferred based on the text:

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

This information is not explicitly stated in terms of numerical acceptance criteria or performance metrics for the VITROS Oncology Controls. The document focuses on demonstrating substantial equivalence to the predicate device. The performance is implied to be acceptable if it is "substantially equivalent" to a legally marketed device.

Characteristic	Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Intended Use	Must be for in vitro use in monitoring the performance of the VITROS System for selected analytes.	Met: "For in vitro use in monitoring the performance of the VITROS Immunodiagnostic System when used for the measurement of selected analytes."
Matrix of Controls	Human serum with added constituents and antimicrobial agents.	Met: "Human serum with added constituents of human origin and antimicrobial agents."
Control Levels	Normal, mildly abnormal, and grossly abnormal.	Met: "normal, mildly abnormal and grossly abnormal."
Expected Values	Derived from minimum of 10 assays with mean and standard deviation for singleton determinations across different laboratories and reagent batches. Lot specific.	Met: Described as above, "Values are lot specific."
Overall Performance	Substantially equivalent to Scantibodies SYSCON Tumor Markers Controls Levels 1 and 2.	Met: "The information presented...demonstrate that the VITROS Oncology Controls are substantially equivalent to the predicate device..."

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 specified. The document mentions "a minimum of 10 assays" for deriving expected values, but this refers to internal characterization, not a formal test set for demonstrating performance against external ground truth.
Data Provenance: Not specified. It mentions "different laboratories using different reagent batches" for deriving expected values, suggesting multi-site involvement, but no specific countries or retrospective/prospective nature are detailed for a formal study.

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):

Not applicable/Not specified. This device is a quality control material, not a diagnostic device that requires expert interpretation for establishing ground truth on patient samples. The "ground truth" for a control material would be its reliably characterized concentration of analytes.

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

Not applicable/Not specified. Adjudication methods are typically used in clinical studies where multiple readers interpret images or data, which is not relevant for a quality control material.

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 quality control material for an immunodiagnostic system, not an AI-powered diagnostic tool, so an MRMC study is irrelevant.

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

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

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

For this type of device (quality control material), the "ground truth" is the analytically determined, characterized concentration of the target analytes within the control material itself. This is established through rigorous laboratory testing (e.g., replicate analyses, use of reference methods, and statistical determination of mean and standard deviation). The document states, "Each control has quoted, for each specific analyte, a mean value derived from a minimum of 10 assays and a standard deviation anticipated for singleton determinations of each control in a number of different laboratories using different reagent batches. Values are lot specific."

8. The sample size for the training set:

Not applicable/Not specified. This device is a physical quality control material and not an AI algorithm requiring a training set in the conventional sense. The "training" in this context would be the internal characterization of the control material (see point 7).

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

Not applicable/Not specified, as it's not an AI algorithm. For the characterization of the control material (its "ground truth"), it was established by "a mean value derived from a minimum of 10 assays and a standard deviation anticipated for singleton determinations of each control in a number of different laboratories using different reagent batches."

Summary

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

3/12/99

Chapter 1 - Summary Information

510(k) Summarv

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: H990531

1. Submitter name, address, contact

Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 (716) 453-3790

Contact Person: Anne Zavertnik

Date 510(k) prepared: February 17, 1999

2. Device Name

Trade or Proprietary Name: VITROS Immunodiagnostic Products Oncology Controls Common Name: Oncology controls Classification Name: 21CFR 862.1660 Quality Control Material (Assayed and Unassayed).

3. Predicate Device

The VITROS Immunodiagnostic Products Oncology controls are substantially equivalent to Scantibodies SYSCON Tumor Markers Controls Levels 1and 2 (K955812).

4. Device Description

The system is comprised of three main elements:

1. The VITROS Immunodiagnostic Products range of products, in this case VITROS Immunodiagnostic Products Reagent Pack, VITROS Immunodiagnostic Products Calibrators which are combined by the VITROS Immunodiagnostic System to perform a VITROS assay.

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

510(k) Summary, continued.

The VITROS Immunodiagnostic System instrumentation, which provides automated use of the 2. 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 Oncology Controls are intended for in vitro use in monitoring the performance of the VITROS Immunodiagnostic System when used for the measurement of selected analytes.

6. Comparison to Predicate Device

The VITROS Immunodiagnostic Products Oncology Controls is substantially equivalent to Scantibodies SYSCON Tumor Markers Controls Levels 1and 2 which was cleared by FDA (K955812) for IVD use.

Table 1 lists the similarities and differences of the device characteristics between the VITROS Oncology Controls and the predicate device.

Table 1 List of the controls characteristics

Characteristics	New Device	Predicate Device
Intended use	For use in monitoringthe performance of theVITROS System whenused for themeasurement ofselected analytes	A human based controlused to monitoranalytical proceduresand reagents fordetecting tumormarkers in patientserum specimens
Matrix of controls	Human serum withadded constituents ofhuman origin andantimicrobial agents	Human serum withadded constituents ofhuman origin andstabilizers
Control levels	normal, mildly abnormaland grossly abnormal	normal and abnormal

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

510(k) Summary, continued.

Table 1, (continued)

Characteristics	New Device	Predicate Device
Expected values	Each control has quoted,for each specific analyte,a mean value derivedfrom a minimum of 10assays and a standarddeviation anticipated forsingleton determinationsof each control in anumber of differentlaboratories usingdifferent reagentbatches. Values are lotspecific.	The mean values printedin the insert werederived from replicateanalyses from themethod referenced andare specific for the lotof the ScantibodiesSYSCON TumorMarker Controls,Levels 1 and 2.Acceptable ranges maybe defined using twostandard deviations ofthe designatedconcentration for eachanalyte based on themean values determinedby each laboratory.

7. Conclusions

The information presented in the pre-market notification demonstrate that the VITROS Oncology Controls are substantially equivalent to the predicate device Scantibodies SYSCON Tumor Marker Controls Levels 1 and 2 which was cleared by FDA (K955812) for IVD use.

The information presented in the premarket notification provide a reasonable assurance that the VITROS Oncology Controls are safe and effective for the stated intended use.

{3}------------------------------------------------

Statement of Accuracy of Foreign Language Translations

Translations for the package inserts and labeling are provided and verified as Statement being accurate by individual regulatory contacts in each of the appropriate countries prior to their release.

It is the policy of Ortho-Clinical Diagnostics to ensure the accuracy of foreign language translations of package inserts and labeling for all products. All new literature is circulated to regulatory personnel for verification of accuracy of translation. We can therefore confirm that foreign language translations of the package insert for VITROS Oncology Controls accurately reflect the English language version.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the left side and top of the logo in a circular fashion.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 2 1999

Anne Zavertnik Regulatory Affairs Associate Ortho-Clinical Diagnostics 100 Indigo Creek Drive Rochester NY 14626-5101

Re: K990531

Trade Name: VITROS Immunodiagnostic Products Oncology Controls Regulatory Class: I Product Code: JJY Dated: February 17, 1999 Received: February 19, 1999

Dear Ms. Zavertnik:

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 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). 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.

{5}------------------------------------------------

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

{6}------------------------------------------------

Statement of Intended Use

Page 1 of 1

510(k) Number (if
known):

Device Name:

Indications for Use:

K990531

VITROS Immunodiagnostic Products Oncology Controls

For in vitro use in monitoring the performance of the VITROS
Immunodiagnostic System when used for the measurement of selected
analytes.

Retin E. Madeni

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ﮨﮯ 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.