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 (in this case VITROS Immunodiagnostic Products TESTOSTERONE Reagent Pack, VITROS Immunodiagnostic Products TESTOSTERONE Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS TESTOSTERONE 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.

AI/ML Overview

The provided text describes the 510(k) summary for the VITROS Immunodiagnostic Products TESTOSTERONE assay, which seeks to establish substantial equivalence to a predicate device, the DPC Coat-A-Count Testosterone assay.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria in the typical sense (e.g., minimum sensitivity, specificity, or agreement percentages). Instead, the primary "acceptance criterion" appears to be substantial equivalence to the predicate device, the DPC Coat-A-Count Testosterone assay.

The reported device performance is demonstrated through a statistical correlation:

Acceptance Criterion	Reported Device Performance (VITROS TESTOSTERONE assay)
Substantial Equivalence to Predicate Device (DPC Coat-A-Count Testosterone assay)	Relationship determined by Deming's Regression: VITROS TESTOSTERONE assay = 0.9222 x DPC Coat-A-Count Testosterone assay - 2.25 nmol/L
Analytical Sensitivity	"tests were performed to obtain analytical sensitivity" (specific values not provided in this summary)
Specificity	"tests were performed to obtain ... specificity" (specific values not provided in this summary)
Precision	"tests were performed to obtain ... precision" (specific values not provided in this summary)
Dilution and Expected Values	"tests were performed to obtain ... dilution and expected values" (specific values not provided in this summary)

2. Sample size used for the test set and the data provenance

Sample Size: The text states, "Comparisons of the VITROS TESTOSTERONE assay and the predicate device were performed with samples from a variety of clinical categories." However, the specific sample size (N) used for this comparison is not mentioned in the provided summary.
Data Provenance: The samples were "patient specimens covering a variety of clinical categories." The country of origin is not specified, and it is described as a comparative study against a predicate device, implying these are real-world patient samples. The information provided does not specify if the data was retrospective or prospective.

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

This information is not provided in the document. For an immunoassay, "ground truth" is typically established by the reference method (in this case, the predicate device) or a gold standard method. The summary doesn't detail how the predicate device's results were established as "ground truth" (e.g., if multiple expert clinical review was involved), nor does it mention any external expert review of the samples used for comparison.

4. Adjudication method for the test set

This information is not applicable/provided. For an immunoassay comparison, adjudication would typically not be a factor in the same way it would be for image-based diagnostic or subjective clinical assessments. The comparison relies on the quantitative measurements of the two 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

This is not applicable. The device is an in vitro diagnostic (IVD) assay for measuring testosterone, not an AI-based imaging or interpretive device that would involve human readers or AI assistance in the way an MRMC study evaluates.

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

This is implicitly a standalone performance evaluation. The VITROS TESTOSTERONE assay is an automated immunoassay system. Its performance (as measured by correlation with the predicate, analytical sensitivity, specificity, etc.) is the performance of the system itself, without direct human intervention in the result generation or interpretation beyond operating the instrument and following its protocol. There isn't an "algorithm" in the typical sense of AI, but rather a chemical and photometric measurement system.

7. The type of ground truth used

The "ground truth" for the performance evaluation is the results obtained from the predicate device, DPC Coat-A-Count Testosterone assay (K813401). The study aims to show substantial equivalence to this already approved device. Additional analytical tests like sensitivity, specificity, and precision were also performed against defined standards or reference materials, which would represent their respective ground truths.

8. The sample size for the training set

This is not provided and is likely not applicable in the context of this type of immunoassay. Immunoassays are "trained" or developed through extensive laboratory work to establish optimal reagent concentrations, reaction conditions, and calibration curves. They are not "trained" on data sets in the way a machine learning algorithm is. The summary refers to "calibration range" and "calibrators" which are used to set up the assay, but not in the sense of a machine learning training set size.

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

As noted above, a "training set" in the machine learning sense is not applicable. The "ground truth" for establishing the assay's performance and calibration is derived from:

Reference materials and standards: For analytical sensitivity, specificity, and precision.
Predicate device measurements: For establishing substantial equivalence using patient samples.
VITROS Immunodiagnostic Products TESTOSTERONE Calibrators: These are likely standardized materials with known testosterone concentrations used to "train" or calibrate the instrument for accurate measurements within its reportable range. How these calibrator values themselves were established is not detailed but would involve rigorous laboratory methods and reference standards.

Summary

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KA983807

NOV 4 1999

Appendices

510(k) Summary (Appendix A)

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: H98350 7

Submitter name, address, contact Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 (716) 453-3607

Contact Person: Anne Zavertnik

Date 510(k) prepared: September 21, 1998

2. Device Name

Trade or Proprietary Name: VITROS Immunodiagnostic Products TESTOSTERONE assay Common Name: Testosterone assay

Classification Name: TESTOSTERONE assay for the in vitro quantitative measurement of testosterone in human serum and plasma (EDTA or heparin).

3. Predicate Device

The VITROS Immunodiagnostic Products TESTOSTERONE assay is substantially equivalent to DPC Coat-A-Count Testosterone assay (K813401).

4. Device Description

The system is comprised of three main elements:

1. The VITROS Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products TESTOSTERONE Reagent Pack, VITROS Immunodiagnostic Products TESTOSTERONE Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS TESTOSTERONE assay).
  Continued on next page

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510(k) Summary (Appendix A), 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 (K984310).

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 TESTOSTERONE assay is intended for the in vitro quantitative measurement of testosterone in human serum or plasma (EDTA or heparin).

6. Comparison to Predicate Device

The VITROS Immunodiagnostic Products TESTOSTERONE assay is substantially equivalent to DPC Coat-A-Count Testosterone assay (predicate device), which was approved by FDA (K813401) for IVD use.

The relationship between the VITROS TESTOSTERONE assay and the predicate device, determined by Deming's Regression, is:

VITROS TESTOSTERONE assay = 0.9222 x DPC Coat-A-Count Testosterone assay - 2.25 nmol/L

Comparisons of the VITROS TESTOSTERONE assay and the predicate device were performed with samples from a variety of clinical categories.

In addition to the studies mentioned above, tests were performed to obtain analytical sensitivity, specificity, precision, dilution and expected values. Refer to the VITROS TESTOSTERONE assay package insert for VITROS TESTOSTERONE assay results.

Table 1 lists the similarities and differences of the device characteristics between the VITROS TESTOSTERONE assay with the predicate device, DPC Coat-A-Count Testosterone assay.

Continued on next page

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510(k) Summary (Appendix A), Continued

Device	VITROS	Predicate
Characteristic	TESTOSTERONE assay	Device
Calibration range	0-75 nmol/L	0.7 - 55 nmol/L
Basic principle	Solid phase immunoassay	Solid phase immunoassay
Tracer	Enzyme labeled	Radio labeled
Instrumentation	VITROS	Microwell plate reader
	Immunodiagnostic System
Sample type	Serum, plasma (EDTA or	Serum, plasma (heparin)
	heparin)
Antibody	Mouse monoclonal anti-	Polyclonal anti-
	testosterone antibody	testosterone antibody
	biotinylated antibody	coated onto
	reagent.	polypropylene tubes.
Sample volume	25 uL	50 uL
Incubation time and	16 minutes at 37° C	3 hours at 37° C
temperature

Table 1 List of the assay characteristics

7. Conclusions

The data presented in the pre-market notification demonstrate that the VITROS TESTOSTERONE assay performs substantially equivalent to the predicate device, for which there is FDA clearance.

Equivalence was demonstrated using currently commercially available reagents along with patient specimens covering a variety of clinical categories.

The data presented in the premarket notification provide a reasonable assurance that the VITROS TESTOSTERONE assay is safe and effective for the stated intended use.

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Public Health Service

Image /page/3/Picture/1 description: The image shows the Department of Health & Human Services logo and text. The text includes the department's name and the date NOV 4 1998. The logo is a stylized human figure.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Anne Zavertnik Requlatory Affairs Associate Ortho-Clinical Diaqnostics, Inc. Requlatory Affairs MC00882 100 Indigo Creek Drive Rochester, New York 14626-5101

к983507 Re: Trade Name: VITROS Immunodiagnostic Products TESTOSTERONE Assay Product Code: 3JY Requlatory Class: I CDZ I II JIX Dated: October 6, 1998 Received: October 7, 1998

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 aqainst 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 Requlations, 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 (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.

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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 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 requlation (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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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

A.L.I

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Statement of Intended Use (Appendix D)

(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)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	K983507

Ortho-Clinical Diagnostics

VITROS Immunodiagnostic Products Testosterone Reagent Pack VITROS Immunodiagnostic Products Testosterone Calibrators VITROS Immunodiagnostic Products Testosterone Controls

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.