VITROS Progesterone Reagent Pack
For in vitro diagnostic use only.
The Vitros Progesterone Reagent Pack quantitatively measures progesterone concentration in human serum and plasma.

VITROS Progesterone Calibrators
For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of progesterone in human serum and plasma (EDTA or heparin).

Device Description

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 and plasma. Coated microwells are used as the solid phase separation system.

The system is comprised of three main elements:

The VITROS Immunodiagnostic Products range of immunoassay products (in this case VITROS Immunodiagnostic Products Progesterone Reagent Pack, VITROS Immunodiagnostic Products Progesterone Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS Progesterone assay).
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) premarket notification (K962919/S1).
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 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).

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

AI/ML Overview

This submission describes the VITROS Immunodiagnostic Products Progesterone Reagent Pack and VITROS Immunodiagnostic Products Progesterone Calibrators (modified), which is a progesterone assay. The device is intended for in vitro diagnostic use to quantitatively measure progesterone concentration in human serum and plasma. The study presented aims to demonstrate substantial equivalence to a legally marketed predicate device (VITROS Immunodiagnostic Products Progesterone Reagent Pack and VITROS Immunodiagnostic Products Progesterone Calibrators).

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details a comparison of assay characteristics between the predicate and the new device. It does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it focuses on substantial equivalence based on comparable characteristics.

Device Characteristic	Predicate Device (Current)	New Device (Modified)	Acceptance Criteria/Performance
Number of Calibrators	3	3	Matches predicate
Nominal Calibrator values	0.0, 4.25, 120 nmol/L	0.0, 4.25, 120 nmol/L	Matches predicate
Physical State of Calibrators	Liquid	Freeze-dried	Change noted; likely evaluated for equivalent performance (details not provided)
Reconstitution Volume	Not required	1 mL	Change noted; likely evaluated for user impact (details not provided)
Storage Temperature of Calibrators	2-8°C	2-8°C	Matches predicate
Calibration range	0 to 178 nmol/L	0 to 178 nmol/L	Matches predicate
Basic principle	Solid phase immunoassay	Solid phase immunoassay	Matches predicate
Tracer	Enzyme labeled	Enzyme labeled	Matches predicate
Instrumentation	VITROS Immunodiagnostic System	VITROS Immunodiagnostic System	Matches predicate
Sample volume	25µL	25µL	Matches predicate
Incubation time and temperature	16 minutes at 37°C with shaking	16 minutes at 37°C with shaking	Matches predicate

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

The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the study). The submission focuses on comparing the modified device's characteristics to a predicate device, rather than providing detailed clinical study results with a test set.

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

Not applicable. This is an in vitro diagnostic device for quantitative measurement, and the ground truth would typically be established by established reference methods or primary analytical measurements, not by expert interpretation in the same way imaging or diagnostic algorithms are validated. The document does not mention the use of experts for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the assessment is based on analytical performance and comparison to a predicate, not on subjective interpretations requiring adjudication.

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 is an in vitro diagnostic device, not an AI-assisted diagnostic tool that involves human readers interpreting results.

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

The device itself is a standalone immunoassay system. The document implies that the performance of the VITROS Progesterone assay (modified) was evaluated on its own analytical capabilities to demonstrate substantial equivalence to the predicate. There is no mention of human interaction beyond the operation of the instrument.

7. The Type of Ground Truth Used

The ground truth for this type of in vitro diagnostic device would typically be established through highly accurate and precise analytical reference methods, or by comparing agreement with the predicate device's established performance, rather than pathology, outcomes data, or expert consensus in an observational or interpretive sense. The document states that "the information presented in the pre-market notification demonstrates that the performance of the VITROS Progesterone assay (modified) for use with human serum and plasma is substantially equivalent to the cleared predicate device." This implies that the 'ground truth' or benchmark for performance comparison is the predicate device's established performance using recognized analytical methods.

8. The Sample Size for the Training Set

The document does not provide details on a "training set" in the context of machine learning. This device is an immunoassay, not an AI/ML-based algorithm that typically requires a training set. The development of such assays involves analytical validation, linearity studies, precision, accuracy, and interference studies, but these do not fall under the conventional definition of a "training set" for AI.

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

Not applicable, as this device does not utilize a "training set" in the AI/ML sense. The "ground truth" for developing and validating immunoassay performance would be derived from rigorous analytical testing using known concentrations of analytes, reference materials, and comparison with established methods.

Summary

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Summary Information

AUG 1 3 2003

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: KO32296.

1. Submitter Ortho-Clinical Diagnostics, Inc. name, 100 Indigo Creek Drive address, Rochester, New York 14626-5101 contact (585) 453-4469
  Contact Person: Susan M. Werner
1. Preparation Date Special 510(k) prepared: July 24, 2003 date
1. Device Trade or Proprietary Name: name VITROS Immunodiagnostic Products Progesterone Reagent Pack VITROS Immunodiagnostic Products Progesterone Calibrators

Common Name: Progesterone assay Classification Name: Progesterone test system (21 CFR 862.1620).

Continued on next page

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510(k) Summary, Continued

The VITROS Immunodiagnostic Products Progesterone Reagent Pack and 4. Predicate device VITROS Immunodiagnostic Products Progesterone Calibrators (modified) are substantially equivalent to the VITROS Immunodiagnostic Products Progesterone Reagent Pack and VITROS Immunodiagnostic Products Progesterone Calibrators (current).
The VITROS Immunodiagnostic System uses luminescence as the signal in 5. Device description the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. 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 immunoassay products (in this case VITROS Immunodiagnostic Products Progesterone Reagent Pack, VITROS Immunodiagnostic Products Progesterone Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS Progesterone assay).
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) premarket notification (K962919/S1).
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 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).

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

Continued on next page

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510(k) Summary, Continued

VITROS Progesterone Reagent Pack 6. Device intended For in vitro diagnostic use only. use The VITROS Progesterone Reagent Pack quantitatively measures Progesterone concentration in human serum and plasma.
VITROS Progesterone Calibrators For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of progesterone in human serum and plasma (EDTA or heparin).
The VITROS Immunodiagnostic Products Progesterone Reagent Pack and 7. Comparison to predicate VITROS Immunodiagnostic Products Progesterone Calibrators (modified) are device substantially equivalent to VITROS Immunodiagnostic Products Progesterone Reagent Pack and Calibrators cleared by the FDA (K022901) for in vitro diagnostic use.
Table 1 lists the characteristics of the modified VITROS Progesterone assay and the current VITROS Progesterone assay.

Table 1: List of Assay Characteristics: Comparison to Predicate Device

DeviceCharacteristic	Predicate DeviceVITROS Progesterone assay(Current)	New DeviceVITROS Progesterone assay(Modified)

Number of Calibrators	3	3
Nominal Calibrator values	0.0, 4.25, 120 nmol/L	0.0, 4.25, 120 nmol/L
Physical State of Calibrators	Liquid	Freeze-dried
Reconstitution Volume	Not required	1 mL
Storage Temperature ofCalibrators	2-8°C	2-8°C
Calibration range	0 to178 nmol/L	0 to178 nmol/L
Basic principle	Solid phase immunoassay	Solid phase immunoassay
Tracer	Enzyme labeled	Enzyme labeled
Instrumentation	VITROS Immunodiagnostic System	VITROS Immunodiagnostic System
Sample volume	25µL	25µL
Incubation time andtemperature	16 minutes at 37°C with shaking	16 minutes at 37°C with shaking

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510(k) Summary, Continued

The information presented in the pre-market notification demonstrates that the 8. Conclusions performance of the VITROS Progesterone assay (modified) for use with human serum and plasma is substantially equivalent to the cleared predicate device.

The information presented in the premarket notification provides a reasonable assurance that the VITROS Progesterone assay (modified) for use with human serum and plasma is safe and effective for the stated intended use.

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Public Health Service

AUG 1 3 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K032296

Trade/Device Name: VITROS Immunodiagnostic Progesterone Reagent Pack VITROS Immunodiagnostic Products Progesterone Calibrators Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIS Dated: July 24, 2003

Received: August 4, 2003

Dear Ms. Werner:

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 misbranding and adulteration.

If your 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). You may obtain other general information on your responsibilities under the Act 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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Indications for Use Statement

Page 1 of 1

510(k) Number (if known):	K032296
Device Name:	VITROS Immunodiagnostic Products Progesterone Reagent PackVITROS Immunodiagnostic Products Progesterone Calibrators
Indications for Use:	VITROS Progesterone Reagent PackFor in vitro diagnostic use only.The Vitros Progesterone Reagent Pack quantitatively measuresprogesterone concentration in human serum and plasma.VITROS Progesterone CalibratorsFor in vitro use in the calibration of the VITROSImmunodiagnostic System for the quantitative measurement ofprogesterone in human serum and plasma (EDTA or heparin).

(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)

Carol C. Benary/s Jean Cooper, DVM

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K032296

Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products Progesterone Reagent Pack VITROS Immunodiagnostic Products Progesterone Calibrators

Page 7 of 47

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.