K Number

Device Name

VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS

Manufacturer

Ortho-Clinical Diagnostics, Inc.

Date Cleared

2003-11-05

(22 days)

Product Code

DDR JIS JJX

Regulation Number

866.5680

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 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 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. - 2. The Vitros Immunodiagnostic System -- instrumentation, which provides automated use of the immunoassay kits. - 3. Common reagents used by the Vitros System in each assay. The Vitros System and common reagents are dedicated specifically for use only with the Vitros Immunodiagnostic Products range of immunoassay products.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K984191, K992349

Reference Devices

K970894, K962919, K964310

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on a standard immunoassay system using luminescence and coated microwells, with no mention of AI/ML terms or functionalities. The performance studies are standard correlation and precision studies, not indicative of AI/ML model validation.

Therapeutic

No
Explanation: This device is an in vitro diagnostic (IVD) device used for the quantitative measurement of myoglobin, aiding in the diagnosis of myocardial infarction. It does not directly provide therapy or treatment to a patient.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is "to aid in the diagnosis of myocardial infarction," which is a diagnostic purpose.

SaMD (Software as a Medical Device)

The device description explicitly states it is comprised of three main elements, including "instrumentation," which is hardware.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states "For the in vitro quantitative measurement of myoglobin concentration in human serum or plasma... to aid in the diagnosis of myocardial infarction." This clearly indicates the device is used to test samples taken from the human body outside of the body (in vitro) for diagnostic purposes.
Device Description: The description details a system that uses immunoassay products and instrumentation to measure analytes in human body fluids. This aligns with the nature of IVD devices.
Calibration and Verification: The intended use also includes calibration and verification of the system for measuring Myoglobin, which are common functions of IVD systems.

The information provided strongly supports the classification of this device as an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

DDR; JIS; JJX

Device Description

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).
1. 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).
1. 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Comparison to predicate device:
The Vitros Myoglobin assay is intended 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. 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 Immunodiagnostic Products Myoglobin Calibrators are substantially equivalent to the DADE Dimension RxL Myoglobin (MYO) Method Reagent Pack and (predicate device) which was cleared by the FDA (K984191) for IVD use. 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).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K984191, K992349

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K970894, K962919, K964310

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 866.5680 Myoglobin immunological test system.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

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.
100 Indigo Creek Drive
Rochester, New York 14626-5101
(585) 453-3730 |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Contact Person: | Charlotte Baker |

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

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

----------------	-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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

---------------------	-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Continued on next page

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).
1. 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).
1. 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

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.

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

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
calibration range of the Vitros
Immunodiagnostic System when
used for the measurement of
Myoglobin. For in vitro use.	Assayed for use in verifying the
calibration range of the Vitros
Immunodiagnostic System when used
for the measurement of cardiac
Troponin I (cTnI). For in vitro use.
Matrix of Range
Verifiers	A base matrix of freeze-dried horse
serum spiked with analyte of human
origin	A base matrix of freeze-dried human
serum spiked with analyte of human
origin.
Range Verifier
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

8. Conclusions

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

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

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).

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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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

Indications for Use Statement

510(k) Number (if known):	K033300
Device Name:	Vitros Immunodiagnostic Products Myoglobin Reagent Pack
Vitros Immunodiagnostic Products Myoglobin Calibrators
Vitros Immunodiagnostic Products Myoglobin Range Verifiers
Indications for 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. |

(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)
---------------------------------------	------------------------------------------------------------------

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