VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS

K033300 · Ortho-Clinical Diagnostics, Inc. · DDR · Nov 5, 2003 · Immunology

Device Facts

• Record ID: K033300
• Device Name: VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: DDR · Immunology
• Decision Date: Nov 5, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5680
• Device Class: Class 2

Intended Use

For the in vitro quantitative measurement of myoglobin concentration in human serum or plasma (EDTA or heparin) to aid in the diagnosis of myocardial infarction. For in vitro use in the calibration of the Vitros Immunodiagnostic System for the quantitative measurement of Myoglobin in human serum and plasma (EDTA or heparin). Assayed for use in verifying the calibration range of the Vitros Immunodiagnostic System when used for the measurement of Myoglobin. For in vitro use.

Device Story

The Vitros Immunodiagnostic System performs quantitative/semi-quantitative analysis of myoglobin in human serum or plasma. The system utilizes coated microwells as a solid-phase separation system and enzyme-labeled tracers. The process involves an automated immunoassay where patient samples (10μL) are incubated for 8 minutes at 37°C with mouse monoclonal anti-myoglobin antibodies. The system measures luminescence as the signal to determine analyte concentration. Used in clinical laboratory settings, the system is operated by trained laboratory personnel. The output provides clinicians with quantitative myoglobin concentration values, which serve as an aid in the diagnosis of myocardial infarction. The device includes reagent packs, calibrators, and range verifiers to ensure system accuracy and calibration range verification.

Clinical Evidence

Bench testing only. Performance established via correlation studies against the DADE Dimension RxL Myoglobin method using a panel of patient samples (r=0.997; slope 0.990; intercept 0.81 ng/mL). Precision, analytical sensitivity, and specificity were evaluated and found acceptable. No clinical prospective or retrospective studies were required.

Technological Characteristics

Solid-phase immunoassay using coated microwells. Employs enzyme-labeled tracers and mouse monoclonal anti-myoglobin antibodies. Sample volume: 10μL. Incubation: 8 minutes at 37°C. Instrumentation: Vitros Immunodiagnostic System. Calibration range: 0-2000 ng/mL. Matrix for verifiers: freeze-dried horse serum spiked with human-origin analyte.

Indications for Use

Indicated for in vitro quantitative measurement of myoglobin in human serum or plasma (EDTA or heparin) to aid in the diagnosis of myocardial infarction.

Regulatory Classification

Identification

A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.

Predicate Devices

• DADE Dimension RxL Myoglobin (MYO) Method (K984191)
• Vitros Troponin I Range Verifiers (K992349)

Submission Summary (Full Text)

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

NOV - 5 2003

# 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: K033300

| 1. Submitter name, address, contact | Ortho-Clinical Diagnostics, Inc.<br>100 Indigo Creek Drive<br>Rochester, New York 14626-5101<br>[phone] |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Contact Person: | Charlotte Baker |

| 2. Preparation date | Date 510(k) prepared: October 10, 2003 |
|---------------------|----------------------------------------|
|---------------------|----------------------------------------|

| 3. Device name | Trade or Proprietary Name:<br>Vitros Immunodiagnostic Products Myoglobin Reagent Pack<br>Vitros Immunodiagnostic Products Myoglobin Calibrators<br>Vitros Immunodiagnostic Products Myoglobin Range Verifiers<br>Common Name: Myoglobin assay<br>Classification Name: Immunoassay Method, Myoglobin (866.5680)<br>Class: II |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 4. Predicate device | a. The Vitros Immunodiagnostic Products Myoglobin assay is substantially equivalent to the DADE Dimension RxL Myoglobin (MYO) Method.<br>b. The Vitros Immunodiagnostic Products Myoglobin Range Verifiers are substantially equivalent to the Vitros Troponin I Range Verifiers. |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

Continued on next page

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

The Vitros Immunodiagnostic System uses luminescence as the signal in the 5. Device quantitative and semi-quantitative determination of selected analytes in description 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: Vitros Immunodiagnostic Products Myoglobin Reagent Pack, the Vitros Immunodiagnostic Products Myoglobin Calibrators and the Vitros Immunodiagnostic Products Myoglobin Range Verifiers, (which are combined by the Vitros Immunodiagnostic System to perform the Vitros Myoglobin assay), and Vitros Immunodiagnostic Products High Sample Diluent B.
Note: High Sample Diluent B was cleared as part of the Vitros Immunodiagnostic Products Total B-hCG Reagent Pack and Vitros Immunodiagnostic Products Total β-hCG Calibrators 510(k) premarket notification (K970894).

- 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 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.

Continued on next page

Ortho-Clinical Diagnostics, Inc.

Vitros Immunodiagnostic Products Myoglobin Reagent Pack Vitros Immunodiagnostic Products Myoglobin Calibrators Vitros Immunodiagnostic Products Myoglobin Range Verifiers Page 5 of 126

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

a. The Vitros Myoglobin assay is intended for the in vitro quantitative 6. Device measurement of myoglobin concentration in human serum or plasma (EDTA, intended use or heparin) to aid in the diagnosis of myocardial infarction. b. The Vitros Myoglobin Range Verifiers are intended for the assayed use in verifying the calibration range of the Vitros Immunodiagnostic System when used for the measurement of Myoglobin. For in vitro use. The Vitros Immunodiagnostic Products Myoglobin Reagent Pack and Vitros 7. a. Comparison to Immunodiagnostic Products Myoglobin Calibrators are substantially predicate device: equivalent to the DADE Dimension RxL Myoglobin (MYO) Method Reagent Pack and (predicate device) which was cleared by the FDA (K984191) for IVD use. Calibrators The relationship between the Vitros Myoglobin and the predicate device, determined by Passing & Bablok, is: Vitros Myoglobin = 0.990 x X +0.81 (ng/mL), with a correlation coefficient of 0.997, where X is DADE Dimension RxL Myoglobin Method. This relationship was determined from a panel of patient samples from a variety of clinical categories. In addition to the above mentioned correlation studies were performed to determine the precision, analytical sensitivity, specificity and expected values of the Vitros Myoglobin assay, (refer to the Vitros Myoglobin Reagent package insert for summaries of the results of these studies). Table 1 lists the characteristics of the assays performed using the Vitros Myoglobin assay and the DADE Dimension RxL Myoglobin (MYO) assay. Continued on next page

Ortho-Clinical Diagnostics, Inc.

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

| 7. a.<br>Comparison to<br>predicate | Table 1<br>Device<br>Characteristic | New Device | Predicate Device |
|---------------------------------------|-------------------------------------|------------------------------------------------|------------------------------------------------|
| device: Reagent | Calibration range | 0-2000 ng/mL | 0-1000 ng/mL |
| Pack and<br>Calibrators,<br>Continued | Basic principle | Solid phase<br>immunoassay | Solid phase<br>immunoassay |
| | Tracer | Enzyme labeled | Enzyme labeled |
| | Instrumentation | Vitros<br>Immunodiagnostic<br>System | DADE Dimension<br>Immunoassay System |
| | Antibody | Mouse monoclonal anti-<br>myoglobin antibodies | Mouse monoclonal anti-<br>myoglobin antibodies |
| | Sample type | Serum and plasma<br>(EDTA or heparin) | Serum and plasma<br>(heparin) |
| | Sample volume | 10μL | 20μL |
| | Incubation time and<br>temperature | 8 minutes at 37°C | 7 minutes at 37°C |

7. b. Comparison to predicate device: Range Verifiers

The Vitros Immunodiagnostic Products Myoglobin Range Verifiers are substantially equivalent to the Vitros Troponin I Range Verifiers (predicate device) which was cleared by the FDA (K992349) for IVD use.

Table 2 lists the similarities and differences of the device characteristics between the Vitros Myoglobin Range Verifiers with the predicate device, Vitros Troponin I Range Verifiers.

| Table 2 | | |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | New Device | Predicate Device |
| Intended Use | Assayed for use in verifying the<br>calibration range of the Vitros<br>Immunodiagnostic System when<br>used for the measurement of<br>Myoglobin. For <i>in vitro</i> use. | Assayed for use in verifying the<br>calibration range of the Vitros<br>Immunodiagnostic System when used<br>for the measurement of cardiac<br>Troponin I (cTnI). For <i>in vitro</i> use. |
| Matrix of Range<br>Verifiers | A base matrix of freeze-dried horse<br>serum spiked with analyte of human<br>origin | A base matrix of freeze-dried human<br>serum spiked with analyte of human<br>origin. |
| Range Verifier<br>Levels | Low and High | Low and High |

Ortho-Clinical Diagnostics, Inc.

Vitros Immunodiagnostic Products Myoglobin Reagent Pack Vitros Immunodiagnostic Products Myoglobin Calibrators Vitros Immunodiagnostic Products Myoglobin Range Verifiers

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

#### 8. Conclusions

| a. Reagent Pack<br>and Calibrators: | Equivalence was demonstrated using currently commercially available<br>reagents along with patient samples by comparing the physical properties<br>and intended uses of these devices with commercially available reagents. |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| b. Range Verifiers: | Both the new device and the predicate device are intended for the assayed<br>use in verifying the calibration range of immunoassays determined by<br>immunoassay analyzers. The new device and predicate device are<br>substantially equivalent. |
| | The data presented in the premarket notification provide a reasonable<br>assurance that the Vitros Myoglobin assay and the Vitros Myoglobin<br>Range Verifiers are safe and effective for the stated intended uses and are<br>substantially equivalent to the cleared predicate devices. |

Vitros Immunodiagnostic Products Myoglobin Reagent Pack Vitros Immunodiagnostic Products Myoglobin Calibrators Vitros Immunodiagnostic Products Myoglobin Range Verifiers

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract image of an eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

NOV - 5 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Charlotte Baker Regulatory Affairs Associate Ortho-Clinic Diagnostics, Inc. Regulatory Affairs MC00881 100 Indigo Creek Drive Rochester, NY 14626-5101

k033300 Re:

> Trade/Device Name: Virtos Immunodiagnostic Products Myoglobin Reagent Pack Virtos Immunodiagnostic Products Myoglobin Calibrators Virtos Immunodiagnostic Products Myoglobin Range Verifiers Regulation Number: 21 CFR 866.5680 Regulation Name: Myoglobin immunological test system Regulatory Class: Class II Product Code: DDR; JIS; JJX Dated: October 10, 2003 Received: October 14, 2003

Dear Ms. Baker:

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).

{6}------------------------------------------------

Page 2 -

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 Putman

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

{7}------------------------------------------------

### Indications for Use Statement

| 510(k) Number (if known): | K033300 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Vitros Immunodiagnostic Products Myoglobin Reagent Pack<br>Vitros Immunodiagnostic Products Myoglobin Calibrators<br>Vitros Immunodiagnostic Products Myoglobin Range Verifiers |
| Indications for Use: | For the in vitro quantitative measurement of myoglobin<br>concentration in human serum or plasma (EDTA or heparin) to<br>aid in the diagnosis of myocardial infarction.<br><br>For in vitro use in the calibration of the Vitros<br>Immunodiagnostic System for the quantitative measurement of<br>Myoglobin in human serum and plasma (EDTA or heparin).<br><br>Assayed for use in verifying the calibration range of the Vitros<br>Immunodiagnostic System when used for the measurement of<br>Myoglobin. For in vitro use. |

#### (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) | <div> <img alt="Checkmark" src="prescription_check.png"/> </div> |
|---------------------------------------|------------------------------------------------------------------|
|---------------------------------------|------------------------------------------------------------------|

OR

| Over-The-Counter Use | |
|----------------------|--|
|----------------------|--|

| Division Sign-Off | Carol Benson |
|-------------------|---------------------|
| | B. Jean Cooper, DVM |

(Optional Format 1-2-96)
Office of In Vitro Diagnostic Device Evaluation and Safety

| 510(k) | K033300 |
|--------|---------|
|--------|---------|

Ortho-Clinical Diagnostics, Inc.

Vitros Immunodiagnostic Products Myoglobin Reagent Pack Vitros Immunodiagnostic Products Myoglobin Calibrators Vitros Immunodiagnostic Products Myoglobin Range Verifiers Page 10 of 126