VITROS IMMUNODIAGNOSTIC PRODUCTS AFP RANGE VERIFIERS

K990061 · Ortho-Clinical Diagnostics, Inc. · JJX · Jan 25, 1999 · Clinical Chemistry

Device Facts

• Record ID: K990061
• Device Name: VITROS IMMUNODIAGNOSTIC PRODUCTS AFP RANGE VERIFIERS
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jan 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 alpha-fetoprotein (AFP).

Device Story

VITROS Immunodiagnostic Products AFP Range Verifiers are used to verify the calibration range of the VITROS Immunodiagnostic System for AFP measurement. The system utilizes luminescence-based immunoassay technology with coated microwells for solid-phase separation. The verifiers consist of low and high levels of human serum-based matrix (freeze-dried human serum or cord serum AFP in human serum). The device is used in clinical laboratory settings by trained personnel. The system instrumentation automates the assay process using specific reagent packs and calibrators. Healthcare providers use the verification results to ensure the accuracy and reliability of the VITROS system's calibration range, supporting clinical decision-making regarding AFP levels in patient samples.

Clinical Evidence

No clinical data provided; bench testing only. Equivalence was demonstrated by comparing physical properties and intended uses with commercially available reagents.

Technological Characteristics

Range verifiers consist of low and high levels of freeze-dried human serum or cord serum AFP in human serum. The system uses luminescence-based immunoassay technology with coated microwells for solid-phase separation. The device is designed for use with the VITROS Immunodiagnostic System instrumentation.

Indications for Use

Indicated for in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System for the measurement of alpha-fetoprotein (AFP).

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 (K964310)

Submission Summary (Full Text)

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# 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: K 99 00(o

#### 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: January, 1999.

#### 2. Device Name

Trade or Proprietary Name: VITROS Immunodiagnostic Products AFP 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 alpha-fetoprotein (AFP).

#### 3. Predicate Device

The VITROS Immunodiagnostic Products AFP 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 AFP Reagent Pack, VITROS Immunodiagnostic Products AFP Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS AFP assay).
Continued on next page

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### 510(k) Summary, 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 (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 alpha-fetoprotein (AFP).

#### 6. Comparison to Predicate Device

The VITROS Immunodiagnostic Products AFP 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 AFP Range Verifiers with the predicate device, VITROS FSH Range Verifiers.

Continued on next page

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# 510(k) Summary, Continued

| | | Table 1 List of the assay characteristics | | |
|--|--|-------------------------------------------|--|--|
|--|--|-------------------------------------------|--|--|

| Device<br>Characteristic | VITROS AFP 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 alpha-<br>fetoprotein (AFP). | 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 serum (low)<br>or cord serum AFP in<br>human serum (high) | 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 |

#### 7. Conclusions

The data presented in the pre-market notification demonstrate that the VITROS AFP 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 AFP Range Verifiers are safe and effective for the stated intended use.

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Public Health Service

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JAN 25 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

K990061 Re:

Trade Name: VITROS Immunodiagnostic Products AFP Range Verifiers Regulatory Class: I Product Code: JJX Dated: January 7, 1999 Received: January 8, 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 Butman

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 K990061 510(k) Number (if known): VITROS Immunodiagnostic Products AFP Range Verifiers Device Name: For in vitro use in verifying the calibration range of the VITROS Indications for Use: Immunodiagnostic System when used for the measurement of alpha-fetoprotein (AFP).

Lesn Cooper
(Division Sign-Off)

Division of Clinical Labo tory Devices 510(k) Number

### (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)

OR

Over-The-Counter Use

(Optional Format 1-2-96)