(71 days)
No
The summary describes a standard immunoassay system for quantitative determination of Myoglobin, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is for "quantitative determination of cardiac Myoglobin in human serum and plasma," which is a diagnostic function, not a therapeutic one.
Yes
The Intended Use section clearly states that the "Measurement of myoglobin aids in the rapid diagnosis of heart and renal disease," indicating its purpose for diagnosis.
No
The device description explicitly states that the system comprises "Myoglobin reagents, Myoglobin calibrators, the Access Access Immunoassay Analyzer and the Access 2 Immunoassay Analyzer," which are all hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "Measurement of myoglobin aids in the rapid diagnosis of heart and renal disease." This indicates the device is used to examine specimens derived from the human body (serum and plasma) to provide information for diagnostic purposes.
- Device Description: The description details "The Myoglobin reagents. Myoglobin calibrators, the Access Access Immunoassay Analyzer and the Access 2 Immunoassay Analyzer comprise the Access Immunoassay Systems for the quantitative determination of cardiac Myoglobin in human serum and plasma." This confirms the device is a system of reagents and analyzers used to perform tests on human samples.
- Performance Studies: The document includes detailed performance studies (Precision, Analytical Sensitivity, Dilution Recovery, Method Comparison, etc.) which are typical for IVD devices to demonstrate their analytical performance.
- Reference Intervals: The establishment of reference intervals for Myoglobin levels in different sample types and genders is a key characteristic of IVD tests used for clinical interpretation.
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
N/A
Intended Use / Indications for Use
The Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac Myoglobin levels in human serum and plasma using the Access Immunoassay Systems.
Measurement of myoglobin aids in the rapid diagnosis of heart and renal disease.
Product codes
DDR, JIS
Device Description
The Myoglobin reagents. Myoglobin calibrators, the Access Access Immunoassay Analyzer and the Access 2 Immunoassay Analyzer comprise the Access Immunoassay Systems for the quantitative determination of cardiac Myoglobin in human serum and plasma.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Precision: Within run imprecision ranged from 1.58%CV to 2.20%CV, betweenrun imprecision ranged from 2.34%CV to 4.24%CV and total imprecision ranged from 3.03%CV to 4.54%CV.
Analytical Sensitivity: The lowest detectable level of Myoglobin distinguishable from zero (Access Myoglobin calibrator S0) with 95% confidence is
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized oval shape on the left, with two curved lines running through it. To the right of the oval is the company name, "BECKMAN COULTER," written in a bold, sans-serif font. The overall design is simple and corporate, with a focus on clarity and readability.
JUN 2 8 2002
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:
: K021229
Submitter's Name and Address
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 Telephone: (952)368-1611 Fax: (952)368-7610 Contact: Bruce Backlund
Date Prepared: April 17, 2002
Device Names
Myoglobin and Myoglobin Calibrators on the Access® Immunoassay Proprietary Name: Systems Common Name: Myoglobin Enzyme Immunoassay Classification Name: Myoglobin, Antigen, Antiserum, Control
Predicate Device
Access® Myoglobin Beckman Coulter Inc. Chaska, MN 55416
510(k) Number: K000196
Device Description
The Myoglobin reagents. Myoglobin calibrators, the Access Access Immunoassay Analyzer and the Access 2 Immunoassay Analyzer comprise the Access Immunoassay Systems for the quantitative determination of cardiac Myoglobin in human serum and plasma.
Intended Use
The Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac Myoglobin levels in human serum and plasma using the Access Immunoassay Systems.
1
Image /page/1/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized oval shape on the left, with two curved lines running through it. To the right of the oval is the text "BECKMAN" in bold, uppercase letters, stacked above the word "COULTER", also in bold, uppercase letters. The logo is black and white.
| Parameter | Access New Myoglobin | Access Current BCI
Myoglobin |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For the quantitative
determination of Myoglobin
levels in human serum and
plasma | For the quantitative
determination of Myoglobin levels
in human serum and plasma |
| Assay Principles | A two-site
immunoenzymatic
("sandwich") assay. A
sample is added to a
reaction vessel with mouse
monoclonal anti-myoglobin-
alkaline phosphatase
conjugate, mouse
monoclonal anti-myoglobin-
biotin conjugate, and
paramagnetic particles
coated with goat anti-biotin. | A two-site
immunoenzymatic
("sandwich") assay. A
sample is
added to a reaction vessel
with mouse monoclonal
anti-myoglobin-alkaline
phosphatase
conjugate, and
paramagnetic particles
coated with mouse
monoclonal anti-myoglobin. |
| Solid Support | Paramagnetic Particles | Paramagnetic Particles |
| Detection System | Utilizes dioxetane-based
chemiluminescent
substrate;
Measures light production
from a chemiluminescent
reaction | Utilizes dioxetane-based
chemiluminescent
substrate;
Measures light production
from a chemiluminescent
reaction |
| Calibrators | Liquid calibrators (frozen)
prepared from buffered
bovine serum albumin
matrix with human cardiac
Myoglobin at specified
levels | Liquid calibrators prepared
from buffered bovine
protein matrix and human
skeletal Myoglobin at
specified levels |
Comparison of Technological Characteristics
Summary of Analytical Studies
Precision: Within run imprecision ranged from 1.58%CV to 2.20%CV, betweenrun imprecision ranged from 2.34%CV to 4.24%CV and total imprecision ranged from 3.03%CV to 4.54%CV.
2
Image /page/2/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized, abstract symbol on the left, resembling an oval shape with two curved lines running through it. To the right of the symbol is the company name, "BECKMAN COULTER," written in a bold, sans-serif font, with "BECKMAN" stacked above "COULTER."
Analytical Sensitivity: The lowest detectable level of Myoglobin distinguishable from zero (Access Myoglobin calibrator S0) with 95% confidence is