VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS

K983513 · Ortho-Clinical Diagnostics, Inc. · JJY · Nov 3, 1998 · Clinical Chemistry

Device Facts

• Record ID: K983513
• Device Name: VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Nov 3, 1998
• 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 immunoassays which include Testosterone and NTx.

Device Story

VITROS Immunodiagnostic Products Range Verifiers consist of freeze-dried human plasma or buffered matrix spiked with specific analytes (Testosterone, NTx). Used in clinical laboratory settings to verify calibration range of VITROS Immunodiagnostic System. System utilizes luminescence-based immunoassay technology with coated microwells for solid phase separation. Range verifiers are processed by the automated VITROS instrumentation alongside patient samples. Healthcare providers use output to confirm system accuracy and calibration stability within defined ranges, ensuring reliable diagnostic results for patient testing.

Clinical Evidence

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

Technological Characteristics

Freeze-dried human plasma or buffered matrix spiked with analyte. Provided in low and high levels. Designed for use with VITROS Immunodiagnostic System (automated luminescence-based immunoassay).

Indications for Use

Indicated for in vitro verification of the calibration range of the VITROS Immunodiagnostic System for Testosterone and NTx assays.

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)

Reference Devices

• VITROS Immunodiagnostic System (K962919)
• VITROS Immunodiagnostic Products Total T3 (K984310)

Submission Summary (Full Text)

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

NOV 3 1998

## 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: 983513 .

#### 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: September 21, 1998

#### 2. Device Name

Trade or Proprietary Name: VITROS Immunodiagnostic Products Testosterone Range Verifiers; VITROS Immunodiagnostic Products NTx 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 Testosterone and NTx.

#### 3. Predicate Device

The VITROS Immunodiagnostic Products Testosterone and NTx 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).
Continued on next page

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

## 510(k) Summary (Appendix A), Continued

- 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 (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

For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of immunoassays which include Testosterone and NTx.

#### 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 TESTOSTERONE Range Verifiers with the predicate device, VITROS FSH Range Verifiers.

Continued on next page

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

## 510(k) Summary (Appendix A), Continued

| Device<br>Characteristic | VITROS<br>Range 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>6 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 base matrix of freeze-<br>dried human plasma or<br>buffered matrix spiked<br>with analyte (see page 6<br>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 Testosterone and NTx 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 Testosterone and NTx Range Verifiers are safe and effective for the stated intended use.

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

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are black and have a simple, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the profiles.

#### 3 1998 NOV

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

K983513 Re: VITROS Immunodiagnostic Products Range Verifiers Trade Name: Requlatory Class: I Product Code: JJY 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 leqally 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The qeneral controls provisions of the Act include requirements for annual reqistration, 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 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 requlation (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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Page 2

This letter will allow you to beqin 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 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

t

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

# Statement of Intended Use (Appendix C)

| 510(k) Number (if known): | K983513 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | VITROS Immunodiagnostic Products Range Verifiers |
| Indications for Use: | For <i>in vitro</i> use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of immunoassays which include Testosterone and NTx. |

Page 1 of 1### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | <div style="text-align:center;">OR</div> | (Division Sign-Off) |
|------------------------------------------|------------------------------------------|---------------------|
|------------------------------------------|------------------------------------------|---------------------|

Division of Clinical Laboratory Devices

| 510(k) Number | K983513 |
|----------------------|---------|
| Over-The-Counter Use | |

(Optional Format 1-2-96)