VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS

K013900 · Ortho-Clinical Diagnostics · JJX · Dec 21, 2001 · Clinical Chemistry

Device Facts

• Record ID: K013900
• Device Name: VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS
• Applicant: Ortho-Clinical Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: Dec 21, 2001
• 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 Vitamin B12.

Device Story

VITROS Immunodiagnostic Products Vitamin B12 Range Verifiers are quality control materials used 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 consist of a buffered matrix containing human serum albumin at specific target concentrations (Low: <90 pg/mL; High: 925 pg/mL). These materials are used by laboratory personnel in a clinical setting to ensure the performance of the VITROS ECi Immunodiagnostic System instrumentation and associated reagent packs. By confirming that the system's measurement range is accurate, the verifiers assist healthcare providers in maintaining the reliability of Vitamin B12 test results, which are used to support clinical decision-making regarding patient nutritional status and metabolic health.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing comparing physical properties and intended use to the predicate device.

Technological Characteristics

Buffered matrix containing liquid human serum albumin. Designed for use with the VITROS Immunodiagnostic System (luminescence-based immunoassay).

Indications for Use

Indicated for in vitro use to verify the calibration range of the VITROS Immunodiagnostic System for Vitamin B12 measurement.

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 Vitamin B12 Range Verifiers (K990026)

Reference Devices

• VITROS ECi 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: _KO13900

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

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

Contact Person: Marlene A. Shulman

Date 510(k) prepared: November 21, 2001

#### 2. Device Name

Trade or Proprietary Name: VITROS Immunodiagnostic Products Vitamin B12 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 Vitamin B12.

#### 3. Predicate Device

The VITROS Immunodiagnostic Products Vitamin B12 Range Verifiers are substantially equivalent to VITROS Immunodiagnostic Products Vitamin B12 Range Verifiers (K990026).

#### 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 ECi Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products Range Verifiers, which are used along with VITROS Immunodiagnostic Products Reagent Pack and VITROS Immunodiagnostic Products Calibrators by the VITROS ECi Immunodiagnostic System to verify the performance of the VITROS assay).

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### 510(k) Summary, Continued.

- 2. The VITROS ECi Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The VITROS ECi System was cleared for market by a separate 510(k) pre-market notification (K962919).
- 3. Common reagents used by the VITROS ECi System in each assay. The VITROS Common rougents asocures 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 ECi 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 Vitamin B12.

#### 6. Comparison to Predicate Device

The VITROS Immunodiagnostic Products Range Verifiers are substantially equivalent to VITROS Vitamin B12 Range Verifiers (predicate device), which was approved by FDA (K990026) for IVD use.

Table 1 lists the similarities and differences of the device characteristics between the VITROS Vitamin B12 Range Verifiers with the predicate device, previously-cleared VITROS Vitamin B12 Range Verifiers.

Continued on next page

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### 510(k) Summary, Continued

Table 1 List of the assay characteristics

| Characteristics | New Device | Predicate Device |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | For use in verifying the calibration<br>range of the VITROS<br>Immunodiagnostic System when<br>used for the measurement of<br>Vitamin B12. | For use in verifying the calibration<br>range of the VITROS<br>Immunodiagnostic System when<br>used for the measurement of<br>Vitamin B12. |
| Matrix of Range<br>Verifiers | Buffered matrix containing liquid<br>human serum albumin | Buffered matrix containing liquid<br>human serum albumin |
| Range Verifier levels | Low:<br>Target Concentration: <90 pg/mL | Low:<br>Target Concentration: <50 pg/mL |
| | High Level:<br>Target Concentration: 925 pg/mL | High Level:<br>Target Concentration: 1900 pg/mL |

#### 7. Conclusions

The data presented in the pre-market notification demonstrate that the VITROS Vitamin B12 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 Vitamin B12 Range Verifiers are safe and effective for the stated intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing to the left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 1 2001

Ms. Marlene A. Shulman Regulatory Affairs Associate Ortho-Clinical Diagnostics Inc. 100 Indigo Creek Drive Rochester, NY 14626-5101

Re: k013900

KU13900
Trade/Device Name: VITROS Immunodiagnostic Products Vitamin B12 Range Verifiers Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: I, reserved Product Code: JJX Dated: November 21, 2001 Received: November 23, 2001

Dear Ms. Shulman:

We have reviewed your Section 510(k) premarket notification of intent to market the device WE have reviewed your bector 3 re(t) pe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regard) the enactment date of the Medical Device American Frances (Fried Days conninered provinces that they 20, 1978, are cannot with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). allo Cosmetic Act (110) that to nov roquilible to the general controls provisions of the Act. The I ou may, dieroloro, manov are a ct include requirements for annual registration, listing of general connois provisions of tactice, 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 If your device is olassimod (600 a00 roy als. Existing major regulations affecting your device can may be subject to satil additions, Title 21, Parts 800 to 898. In addition, FDA may oublish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loast of advisod that I DTC issualite over device complies with other requirements of the Act that I Dri has made a dolly and regulations administered by other Federal agencies. You must or any I oderal statues and regirements, including, but not limited to: registration and listing (21 eomply with an the 11th 011 0 0 0 1 0 0 manufacturing practice requirements as set Of It in the quality systems (21 CFR Part 820); and if applicable, the electronic form in the qualion control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

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 nredicate 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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Gutman

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

| 510(k) Number (if known): | K013900 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | VITROS Immunodiagnostic Products Vitamin B12 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 Vitamin B12. |

Page 1 of 1(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K013900

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ ← (Per 21 CFR 801.109)

OR

Over-The-Counter Use _

(Qptional Format 1-2-96)