VITROS IMMUNODIAGNOSTIC PRODUCTS CA15-3 RANGE VERIFIERS, CA125 II RANGE VERIFIERS, PSA RANGE VERIFIERS

K990783 · Ortho-Clinical Diagnostics, Inc. · JJX · Mar 25, 1999 · Clinical Chemistry

Device Facts

• Record ID: K990783
• Device Name: VITROS IMMUNODIAGNOSTIC PRODUCTS CA15-3 RANGE VERIFIERS, CA125 II RANGE VERIFIERS, PSA RANGE VERIFIERS
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Mar 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of DF3 defined antigen, OC 125 defined antigen or PSA.

Device Story

VITROS Immunodiagnostic Products Range Verifiers are liquid buffered matrices spiked with specific analytes (CA 15-3, CA 125 II, PSA). Used in clinical laboratory settings to verify the calibration range of the VITROS Immunodiagnostic System. The system utilizes luminescence-based immunoassay technology with coated microwells for solid-phase separation. The verifiers are provided in low and high levels. Laboratory technicians use these products to ensure system accuracy within the established calibration range for the specified analytes. This verification process supports the reliability of patient test results, aiding clinicians in the management of patients requiring these specific antigen measurements.

Clinical Evidence

No clinical data. Substantial equivalence is demonstrated through comparison of physical properties and intended use with the predicate device.

Technological Characteristics

Liquid buffered matrix spiked with analyte; low and high levels. Operates as part of the VITROS Immunodiagnostic System using luminescence-based immunoassay technology with coated microwells. System instrumentation and common reagents (Signal Reagent, Universal Wash Reagent) are previously cleared (K962919, K964310).

Indications for Use

Indicated for in vitro verification of the calibration range of the VITROS Immunodiagnostic System for the measurement of DF3 defined antigen, OC 125 defined antigen, or PSA in human body fluids (serum, plasma, urine).

Regulatory Classification

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.

Predicate Devices

• VITROS Immunodiagnostic Products FSH Range Verifiers (K973517)

Submission Summary (Full Text)

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3/25/99

# 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: H990783 .

#### 1. Submitter name, address, contact

Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 [phone]

Contact Person: Anne Zavertnik

Date 510(k) prepared: March 4, 1999

#### 2. Device Name

Trade or Proprietary Name: VITROS Immunodiagnostic Products CA 15-3™ Range Verifiers: VITROS Immunodiagnostic Products CA 125 II™ Range Verifiers, and VITROS Immunodiagnostic Products PSA Range Verifiers.

Common Name: Range Verifiers

Classification Name: VITROS Range verifiers for use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of immunoassays which include CA 15-3, CA 125 II and PSA.

#### 3. Predicate Device

The VITROS Immunodiagnostic Products CA 15-3, CA 125 II and PSA Range Verifiers are substantially equivalent to VITROS Immunodiagnostic Products FSH Range Verifiers (K973517).

#### 4. 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, 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 Reagent Pack, VITROS Immunodiagnostic Products Calibrators, which are combined by the VITROS Immunodiagnostic System to perform a VITROS assay).

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- 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) pre-market notification (K962919).
- 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 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

For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of DF3 defined antigen, OC 125 defined antigen or PSA.

#### 6. Comparison to Predicate Device

The VITROS Immunodiagnostic Products Range Verifiers are substantially equivalent to VITROS FSH Range Verifiers (predicate device), which was approved by FDA (K973517) for IVD use.

Table 1 lists the similarities and differences of the device characteristics between the VITROS CA 15-3. CA 125 II and PSA Range Verifiers with the predicate device, VITROS FSH Range Verifiers.

Continued on next page

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## 510(k) Summary, Continued

| Device<br>Characteristic | VITROS CA 15-3, CA<br>125 II AND PSA Range<br>Verifiers | Predicate<br>Device |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | For use in verifying the<br>calibration range of the<br>VITROS<br>Immunodiagnostic System<br>when used for the<br>measurement of a<br>particular analyte (see page<br>11 for a list of analytes). | For use in verifying the<br>calibration range of the<br>VITROS<br>Immunodiagnostic<br>System when used for the<br>measurement of FSH. |
| Matrix of Range Verifiers | A liquid buffered matrix<br>spiked with analyte (see<br>page 11 for full details). | A base matrix of freeze-<br>dried human plasma<br>spiked with human<br>pituitary FSH. |
| Range Verifier levels | Low and high | Low and high |

Table 1 List of the assay characteristics

#### 7. Conclusions

The data presented in the pre-market notification demonstrate that the VITROS CA 15-3, CA 125 II and PSA Range Verifiers are substantially equivalent to the predicate device, for which there is FDA clearance.

Equivalence was demonstrated by comparing the physical properties and intended uses of these devices with commercially available reagents.

The data presented in the premarket notification provide a reasonable assurance that the VITROS CA 15-3, CA 125 II and PSA Range Verifiers are safe and effective for the stated intended use.

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Public Health Service

Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

MAR 2 5 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Anne Zavertnik Regulatory Affairs Associate Ortho-Clinical Diagnostics A•Johnson & Johnson Company 100 Indigo Creek Drive Rochester, New York 14626-5101

K990783 Re:

Trade Name: VITROS Immunodiagnostic Products CA 15-3 Range Verifiers VITROS Immunodiagnostic Products CA 125 II Range Verifiers VITROS Immunodiagnostic Products PSA Range Verifiers

Regulatory Class: I Product Code: JJX Dated: March 4, 1999 Received: March 9, 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 (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

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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [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 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 K 990783 510(k) Number (if known): 1. VITROS Immunodiagnostic Products CA 15-3 Range Verifiers Device Name: 2. VITROS Immunodiagnostic Products CA 125 II Range Verifiers 3. VITROS Immunodiagnostic Products PSA Range Verifiers 1. For in vitro use in verifying the calibration range of the VITROS Indications for Use: Immunodiagnostic System when used for the measurement of DF3 defined antigen. 2. For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of OC 125 defined antigen. 3. For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of PSA.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| | <img alt="Signature" src="signature.png"/> |
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K990783 |

| Prescription Use<br>(Per 21 CFR 801.109) | <span style="font-size: 2em;">✓</span> |
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OR

| Over-The-Counter Use | |
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(Optional Format 1-2-96)