VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS

K032296 · Ortho-Clinical Diagnostics, Inc. · JIS · Aug 13, 2003 · Clinical Chemistry

Device Facts

• Record ID: K032296
• Device Name: VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: JIS · Clinical Chemistry
• Decision Date: Aug 13, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

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 Story

The VITROS Progesterone assay is a solid-phase immunoassay used for the quantitative determination of progesterone in human serum and plasma. The system utilizes coated microwells as a solid-phase separation system and enzyme-labeled tracers to generate a luminescent signal. The device is operated on the VITROS Immunodiagnostic System, which automates the immunoassay process. The system processes 25µL samples with a 16-minute incubation at 37°C. The output is a quantitative progesterone concentration value, which clinicians use to assess patient hormone levels. The device is intended for professional use in clinical laboratory settings.

Clinical Evidence

Bench testing only; verification and validation activities performed per design control requirements to confirm performance of freeze-dried calibrators.

Technological Characteristics

Solid-phase immunoassay using enzyme-labeled tracers and luminescence detection. Instrumentation: VITROS Immunodiagnostic System. Calibrators: Freeze-dried, 1 mL reconstitution volume, stored at 2-8°C. Sample type: Human serum and plasma (EDTA or heparin).

Indications for Use

Indicated for the quantitative measurement of progesterone concentration in human serum and plasma (EDTA or heparin) for in vitro diagnostic use.

Regulatory Classification

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.)

Special Controls

*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.

Submission Summary (Full Text)

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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 [phone]
Contact Person: Susan M. Werner

- 2. Preparation Date Special 510(k) prepared: July 24, 2003 date
- 3. 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).

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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).
- 2. 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).
- 3. 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.

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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

| Device<br>Characteristic | Predicate Device<br>VITROS Progesterone assay<br>(Current) | New Device<br>VITROS Progesterone assay<br>(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 of<br>Calibrators | 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 and<br>temperature | 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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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 [phone]. 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 [phone] or [phone] 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 Pack<br>VITROS Immunodiagnostic Products Progesterone Calibrators |
| Indications for Use: | VITROS Progesterone Reagent Pack<br>For in vitro diagnostic use only.<br>The Vitros Progesterone Reagent Pack quantitatively measures<br>progesterone concentration in human serum and plasma.<br><br>VITROS Progesterone Calibrators<br>For in vitro use in the calibration of the VITROS<br>Immunodiagnostic System for the quantitative measurement of<br>progesterone 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

OR

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

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