K Number
K053576
Device Name
DIMENSION VISTA MYO REAGENT CARTRIDGE AND CALIBRATOR
Manufacturer
Date Cleared
2006-02-07

(47 days)

Product Code
Regulation Number
862.1150
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Method: For the quantitative measurement of myoglobin in human serum and plasma on the Dimension Vista™ System as an aid in the rapid diagnosis of acute myocardial infarction. Calibrator: For the calibration of the myoglobin (MYO) method on the Dimension Vista™ System.
Device Description
Method: The MYO method is a homogenous sandwich chemiluminescent immunoassay based on Luminescent Oxygen Channeling Immunoassay (1.OCI™) technology. LOCI™ reagents include two latex bead reagents and a biotinylated anti-myoglobin monoclonal antibody fragment. The first bead reagent (Sensibeads) is coated with streptavidin and contains photosensitizer dye. The second bead reagent (Chemibeads) is coated with a second anti-myoglobin monoclonal antibody and contains chemiluminescent dye. Sample is incubated with Chemibeads and biotinylated antibody to form a beadmyoglobin-biotinylated antibody sandwich. Sensibeads are added and bind to the biotin to form bead-pair immunocomplexes. Illumination of the complex by light at 680 nm generates singlet oxygen from Sensibeads which diffuses into Chemibeads, triggering a chemiluminescent reaction. The resulting signal is measured at 612 nm and is a direct function of the myoglobin concentration in the sample. Calibrator: The Dade Behring MYO Calibrator is a three level (A, B, C), frozen liquid product containing purified human heart myoglobin in a 6% bovine albumin matrix with stabilizers and preservatives. The kit contains 3 vials of each level (A= 2.0 mL. B= 1.0 mL. C= 1.5 mL).
More Information

Not Found

No
The description details a standard immunoassay technology (LOCI™) and its performance characteristics. There is no mention of AI, ML, or any computational methods beyond basic statistical analysis for method comparison and reproducibility.

No.
The device is for the quantitative measurement of myoglobin as an aid in the diagnosis of acute myocardial infarction, which is a diagnostic purpose, not a therapeutic one.

Yes
The intended use states that the device is "an aid in the rapid diagnosis of acute myocardial infarction."

No

The device description clearly details a homogenous sandwich chemiluminescent immunoassay based on LOCI™ technology, involving physical reagents (latex beads, antibodies, dyes) and a physical calibrator. This is a laboratory assay, not a software-only device.

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

Here's why:

  • Intended Use: The intended use explicitly states "For the quantitative measurement of myoglobin in human serum and plasma... as an aid in the rapid diagnosis of acute myocardial infarction." This clearly indicates the device is used to test samples taken from the human body (in vitro) to provide information for diagnostic purposes.
  • Method: The description of the method details a "homogenous sandwich chemiluminescent immunoassay" performed on "human serum and plasma." This is a laboratory-based test performed on biological samples.
  • Device Description: The description of both the Method and the Calibrator confirms they are reagents and materials used in a laboratory setting to perform a diagnostic test on human samples.
  • Performance Studies: The performance studies describe testing performed on "serum and heparinized plasma patient samples," further confirming the use of human biological samples.

The definition of an In Vitro Diagnostic (IVD) device is a medical device that is used to perform tests on samples such as blood, urine, or tissue, to detect diseases or other conditions. This device fits that definition perfectly.

N/A

Intended Use / Indications for Use

Method
For the quantitative measurement of myoglobin in human serum and plasma on the Dimension Vista™ System as an aid in the rapid diagnosis of acute myocardial infarction.

Calibrator
For the calibration of the myoglobin (MYO) method on the Dimension Vista™ System.

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

DDR, JIT

Device Description

Method
The MYO method is a homogenous sandwich chemiluminescent immunoassay based on Luminescent Oxygen Channeling Immunoassay (1.OCI™) technology. LOCI™ reagents include two latex bead reagents and a biotinylated anti-myoglobin monoclonal antibody fragment. The first bead reagent (Sensibeads) is coated with streptavidin and contains photosensitizer dye. The second bead reagent (Chemibeads) is coated with a second anti-myoglobin monoclonal antibody and contains chemiluminescent dye. Sample is incubated with Chemibeads and biotinylated antibody to form a beadmyoglobin-biotinylated antibody sandwich. Sensibeads are added and bind to the biotin to form bead-pair immunocomplexes. Illumination of the complex by light at 680 nm generates singlet oxygen from Sensibeads which diffuses into Chemibeads, triggering a chemiluminescent reaction. The resulting signal is measured at 612 nm and is a direct function of the myoglobin concentration in the sample.

Calibrator
The Dade Behring MYO Calibrator is a three level (A, B, C), frozen liquid product containing purified human heart myoglobin in a 6% bovine albumin matrix with stabilizers and preservatives. The kit contains 3 vials of each level (A= 2.0 mL. B= 1.0 mL. C= 1.5 mL).

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)

Method Comparison
A split sample method comparison demonstrated good agreement between the Dade Behring Dimension Vista™ MYO method and the predicate Dade Behring Dimension® MYO immunoassay with serum and heparinized plasma patient samples.
Sample size: 160
Slope: 1.003
Intercept (ng/mL): 6.98
Correlation Coefficient: 0.998
The range of MYO values in the correlation study was: 12 to 932 ng/mL.

Serum/Plasma Comparison
Serum and heparin plasma matched pairs were examined on the Dimension Vista™ system. Serum samples (n=37) ranging from 28 to 600 ng/mL when compared to lithium heparin samples gave a slope of 1.05, correlation coefficient of 1.0, and an intercept of -5.12 ng/mL using linear least squares regression statistics.
A separate study was conducted to evaluate the comparison of 115 lithium and sodium heparin samples ranging from 16 ng/mL to approximately 823 ng/mL. A linear least squares regression analysis comparing the lithium to sodium heparin samples gave a slope of 1.00, a correlation coefficient of 1.0, and an intercept of -0.54 ng/mL.

Reproducibility
Typical precision observed for the Dimension Vista™ MYO method is summarized below:
Human Serum Pool:
Pool 1: Mean 110.3 ng/mL, Repeatability SD 5.4 ng/mL, %CV 4.9, Within Lab SD 5.5 ng/mL, %CV 5.0
Pool 2: Mean 501.5 ng/mL, Repeatability SD 17.3 ng/mL, %CV 3.4, Within Lab SD 18.7 ng/mL, %CV 3.7
Pool 3: Mean 830.8 ng/mL, Repeatability SD 23.1 ng/mL, %CV 2.8, Within Lab SD 27.6 ng/mL, %CV 3.3
Biorad Liquichek™Cardiac Marker Control LT:
Level 1: Mean 113.5 ng/mL, Repeatability SD 2.7 ng/mL, %CV 2.4, Within Lab SD 4.0 ng/mL, %CV 3.6
The reproducibility testing was conducted in accordance with the NCCLS (CLSI) Approved Guideline for User Evaluation of Precision Performance of Clinical Chemistry Devices EP5-A2. For each test level, a single test from two independent cups was analyzed twice per day. The within-run and total standard deviations were calculated by the analysis of variance method.

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/K984193

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.

Not Found

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

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

0

K 053576

SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

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.

| Submitter's Name: | George M. Plummer
Dade Behring Inc.
P.O. Box 6101
Newark, DE 19714-6101 |
|-----------------------------|----------------------------------------------------------------------------------|
| Date of Preparation: | December 20, 2005 |
| Name of Product(s): | Dimension Vista™ MYO reagent cartridge and
Dimension Vista™ MYO calibrator |
| FDA Classification Name(s): | Myoglobin, Antigen, Antiserum, Control and associated calibrator |
| FDA Guidance Documents: | Not applicable |
| Predicate Device(s): | Dade Behring MYO immunoassay and Calibrator
(K984191/K984193) |

Device Description(s):

Method

The MYO method is a homogenous sandwich chemiluminescent immunoassay based on Luminescent Oxygen Channeling Immunoassay (1.OCI™) technology. LOCI™ reagents include two latex bead reagents and a biotinylated anti-myoglobin monoclonal antibody fragment. The first bead reagent (Sensibeads) is coated with streptavidin and contains photosensitizer dye. The second bead reagent (Chemibeads) is coated with a second anti-myoglobin monoclonal antibody and contains chemiluminescent dye. Sample is incubated with Chemibeads and biotinylated antibody to form a beadmyoglobin-biotinylated antibody sandwich. Sensibeads are added and bind to the biotin to form bead-pair immunocomplexes. Illumination of the complex by light at 680 nm generates singlet oxygen from Sensibeads which diffuses into Chemibeads, triggering a chemiluminescent reaction. The resulting signal is measured at 612 nm and is a direct function of the myoglobin concentration in the sample.

Calibrator

The Dade Behring MYO Calibrator is a three level (A, B, C), frozen liquid product containing purified human heart myoglobin in a 6% bovine albumin matrix with stabilizers and preservatives. The kit contains 3 vials of each level (A= 2.0 mL. B= 1.0 mL. C= 1.5 mL).

Intended Use:

Method

For the quantitative measurement of myoglobin in human serum and plasma on the Dimension Vista™ System as an aid in the rapid diagnosis of acute myocardial infarction.

Calibrator

For the calibration of the myoglobin (MYO) method on the Dimension Vista™ System.

1

Comparison to Predicate Device:

Method

A summary of the features of the Dade Behring Dimension Vista™ MYO reagent cartridge and the A summal y of the reatures of the Dade Bearing = mmunoassay (K984191/K984193) is provided in the following charts.

FeatureDimension® MYODimension Vista™ MYO
Intended UseFor the in vitro quantitative
determination of myoglobin in
human serum and heparinized
plasma as an aid in the diagnosis of
myocardial infarction.For the in vitro quantitative
determination of myoglobin in human
serum and heparinized plasma as an
aid in the diagnosis of myocardial
infarction.
Assay Type
(detection)photometric immunoassaychemiluminescent immunoassay
Reportable Range1 to 1000 ng/mL0.5 - 1000 ng/mL
AntibodyDade Behring mouse monoclonalDade Behring mouse monoclonal
Analytical
Sensitivity1 ng/mL0.5 ng/mL
Analytical
SpecificityThere are no known cross reactive
materials.There are no known cross reactive
materials.
InterferencesNo significant interference from:
bilirubin up to 60 mg/dL,
hemoglobin up to 1000 mg/dL and
triglycerides up to 1500 mg/dLNo significant interference from:
bilirubin, conj. up to 60 mg/dL
bilirubin, unconjugated up to 60
mg/dL, hemoglobin up to 1000
mg/dL and triglycerides up to 3000
mg/dL
Hook EffectNo high dose effect
(up to 300,000 ng/mL)No high dose effect
(up to 300,000 ng/mL)
Calibration IntervalCalibration curve updated for each
lot, using five levels and every 90
days, thereafter with the same
reagent lot.Calibration curve updated for each
lot, using six levels every 30 days
with the same reagent lot.
Sample Volume20 uL2 uL
FeatureDimension® MYODimension Vista™ MYO
Intended UseMYO method calibrationMYO method calibration
AnalyteHuman heart myoglobinHuman heart myoglobin
MatrixBovine serum albuminBovine serum albumin
FormLiquidFrozen liquid
Volume10 vials, 2 at each level, 1 mL each9 vials, 3 at each level, 2.0, 1.0, 1.5 mL for level A, B, C, respectively
Levels5 levels (0, 35, 100, 500, and 1060 ng/mL)3 levels provided (0, 125 and 1050 ng/mL); 3 additional levels made on-board (36.7, 367 and 733 ng/mL)

Method:

2

Calibrator:

Method performance Summary:

Analytical Results

Method Comparison

A split sample method comparison demonstrated good agreement between the Dade Behring Dimension Vista™ MYO method and the predicate Dade Behring Dimension® MYO immunoassay with serum and heparinized plasma patient samples.

| Comparative
Method | Slope | Intercept
(ng/mL) | Correlation
Coefficient | n |
|-----------------------|-------|----------------------|----------------------------|-----|
| Dimension® MYO | 1.003 | 6.98 | 0.998 | 160 |

The model equation for linear regression statistics is: [results for Dimension Vista™ MYO] = slope x [comparative method results] + intercept. The range of MYO values in the correlation study was: 12 to 932 ng/mL.

Serum/Plasma Comparison

Serum and heparin plasma matched pairs were examined on the Dimension Vista™ system. Serum samples (n=37) ranging from 28 to 600 ng/mL when compared to lithium heparin samples gave a slope of 1.05, correlation coefficient of 1.0, and an intercept of -5.12 ng/mL using linear least squares regression statistics.

A separate study was conducted to evaluate the comparison of 115 lithium and sodium heparin samples ranging from 16 ng/mL to approximately 823 ng/mL. A linear least squares regression analysis comparing the lithium to sodium heparin samples gave a slope of 1.00, a correlation coefficient of 1.0, and an intercept of -0.54 ng/mL.

3

Reproducibility Typical precision observed for the Dimension Vista™ MYO method is summarized below:

SampleMean (ng/mL)RepeatabilityWithin Lab
SD (ng/mL)%CVSD (ng/mL)%CV
Human Serum Pool
Pool 1110.35.44.95.55.0
Pool 2501.517.33.418.73.7
Pool 3830.823.12.827.63.3
Biorad Liquichek™Cardiac Marker Control LT
Level 1113.52.72.44.03.6
  • Liquichek™ is a registered trademark of Biorad Laboratories, Irvine CA.

The reproducibility testing was conducted in accordance with the NCCLS (CLSI) Approved Guideline for User Evaluation of Precision Performance of Clinical Chemistry Devices EP5-A2. For each test level, a single test from two independent cups was analyzed twice per day. The within-run and total standard deviations were calculated by the analysis of variance method.

Calibrator

The Dimension Vista™ MYO calibrator is similar to other calibrator products associated with their assays, such as the Dimension® MYO calibrator.

Comments on Substantial Equivalence:

Both the Dimension Vista™ MYO reagent cartridge and the Dimension® MYO immunoassays are intended for the quantitative determination of myoglobin. Comparative data for serum and human plasma samples demonstrate good analytical and clinical agreement between the methods.

Conclusion:

The Dade Behring Dimension Vista™ MYO and the predicate Dade Behring Dimension® MYO immunoassays (K984191/K984193) are substantially equivalent based on their intended use and performance characteristics as described above. The calibrator products are also equivalent in their design and intended use with their respective assay systems.

Gmt. Plummer

George M. Plummer Regulatory Affairs and Compliance Manager December 20, 2005

4

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, and the words "U.S. Department of Health & Human Services - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The background is white.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 7 2006

Mr. George M. Plummer Regulatory Affairs & Compliance Manager Dade Behring Inc. Glasgow Business Community Bldg. 500. M.S. 514 PO Box 6101 Newark, DE 19714-6101

K053576 Re:

Trade/Device Name: Dimension Vista™ MYO reagent cartridge and Dimension Vista™ MYO calibrator Regulation Number: 21 CFR§ 866.5680 Regulation Name: Myoglobin immunological test system Regulatory Class: Class II Product Code: DDR, JIT Dated: December 20, 2005 Received: December 23, 2005

Dear Mr. Plummer:

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).

5

Page 2 --

This letter will allow you to begin marketing your device as described in your Section 510(k) rms lot 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 (240) 276-0484. 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/industry/support/index.html.

Sincerely yours,

Alberto Garcia, Ph.D.

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

6

INDICATIONS FOR USE STATEMENT

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510(k) Number (If Known):

Device(s) Name(s):

Dimension Vista™ MYO reagent cartridge and Dimension Vista™ MYO calibrator

Indications for Use:

Method

For the quantitative measurement of myoglobin in human serum and plasma on the Dimension Vista™ System as an aid in the rapid diagnosis of acute myocardial infarction.

Calibrator

Prescription Use

For the calibration of the myoglobin (MYO) method on the Dimension Vista™ System.

Prescription Use
(Part 21 CFR 801 Subpart D)

and/or

Over-the-counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ============================================================================================================================================================================= ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Qim Chappie
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

K053576