(88 days)
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No
The summary describes a standard immunoassay for quantitative determination of myoglobin levels and does not mention any AI or ML components in the device description or performance studies.
No.
This device is an in vitro diagnostic (IVD) immunoassay that quantitatively determines myoglobin levels to aid in diagnosis, not to provide treatment.
Yes
The first paragraph under "Intended Use / Indications for Use" states that the assay is used "to aid in the diagnosis of heart or renal disease."
No
The device is an in vitro diagnostic (IVD) assay kit consisting of reagents and calibrators, designed for use with a specific hardware analyzer (Dxl 9000 Access Immunoassay Analyzer). It is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of myoglobin levels in human serum and plasma." This is a test performed on samples taken from the human body, but outside of the body (in vitro).
- Device Description: It describes a "paramagnetic particle, chemiluminescent immunoassay" and mentions "reagent pack and calibrators," which are typical components of in vitro diagnostic tests. It also specifies use with an "Immunoassay Analyzer in a clinical laboratory setting," further indicating an in vitro diagnostic application.
- Anatomical Site: It explicitly states "Not Applicable (In vitro diagnostic)," confirming its nature as a test performed outside the body.
- Intended User / Care Setting: "clinical laboratory setting" is where IVD tests are typically performed.
N/A
Intended Use / Indications for Use
The Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of myoglobin levels in human serum and plasma using the Access Immunoassay Systems to aid in the diagnosis of heart or renal disease.
Product codes (comma separated list FDA assigned to the subject device)
DDR
Device Description
The Access Myoglobin assay is a sandwich immunoenzymatic assay. The Access Myoglobin assay consists of the reagent pack and calibrators. Other items needed to run the assay include substrate and wash buffer. The Access Myoqlobin assay reagent pack, Access Myoqlobin assay calibrators, along with the UniCel Dxl Wash Buffer II are designed for use with the Dxl 9000 Access Immunoassay Analyzer in a clinical laboratory setting.
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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison: A study based on CLSI EP09c, 3rd Edition using Weighted Deming regression and Pearson's correlation compared the Access 2 Immunoassay System and the Dxl 9000 Access Immunoassay Analyzer.
N: 155
Concentration Range (ng/mL): 8.2 – 3900
Slope: 0.99
Slope 95% CI: 0.98 – 1.00
Intercept: 0.47
Intercept 95% CI: -0.10 – 1.0
R: 1.00
Imprecision: A study based on CLSI EP05-A3 performed on the Dxl 9000 Access Immunoassay Analyzer tested multiple samples in duplicate in 2 runs per day for a minimum of 20 days.
Sample 1: N=80, Mean=7.9, Repeatability (Within-Run) SD=0.18, %CV=2.3; Between-Run SD=0.18, %CV=2.2; Between-Day SD=0.17, %CV=2.2; Within-Laboratory SD=0.31, %CV=3.9
Sample 2: N=80, Mean=101, Repeatability (Within-Run) SD=2.2, %CV=2.1; Between-Run SD=4.0, %CV=4.0; Between-Day SD=3.0, %CV=3.0; Within-Laboratory SD=5.5, %CV=5.4
Sample 3: N=80, Mean=465, Repeatability (Within-Run) SD=8.0, %CV=1.7; Between-Run SD=15.1, %CV=3.2; Between-Day SD=0.0, %CV=0.0; Within-Laboratory SD=17.0, %CV=3.7
Sample 4: N=80, Mean=1763, Repeatability (Within-Run) SD=35.0, %CV=2.0; Between-Run SD=57.5, %CV=3.3; Between-Day SD=0.1, %CV=0.0; Within-Laboratory SD=67.3, %CV=3.8
Sample 5: N=80, Mean=2719, Repeatability (Within-Run) SD=54.8, %CV=2.0; Between-Run SD=85.9, %CV=3.2; Between-Day SD=0.0, %CV=0.0; Within-Laboratory SD=101.9, %CV=3.7
Linearity: A study based on CLSI EP06-Ed2 performed on the Dxl 9000 Access Immunoassay Analyzer determined the assay demonstrated linearity across the measuring interval.
Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ): Studies were conducted on the Dxl 9000 Access Immunoassay Analyzer following CLSI guideline EP17-A2. The LoB study included multiple reagent lots and 3 instruments over a minimum of 3 days. The LoD and LoQ studies included multiple reagent lots and 3 instruments over a minimum of 5 days.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
LoB: 3.0 ng/mL
LoD: 3.0 ng/mL
LoQ (≤ 20% within-lab CV): 3.0 ng/mL
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.
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.
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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
§ 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
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September 18, 2023
Beckman Coulter, Inc. Kate Oelberg Senior Staff Quality and Regulatory Affairs 1000 Lake Hazeltine Drive Chaska, Minnesota 55318
Re: K231832
Trade/Device Name: Access Myoglobin Regulation Number: 21 CFR 866.5680 Regulation Name: Myoglobin Immunological Test System Regulatory Class: Class II Product Code: DDR Dated: June 21, 2023 Received: June 22, 2023
Dear Kate Oelberg:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Paula V. Caposino -S
Paula Caposino, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K231832
Device Name Access Myoglobin
Indications for Use (Describe)
The Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of myoglobin levels in human serum and plasma using the Access Immunoassay Systems to aid in the diagnosis of heart or renal disease.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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.
510(k) Number K231832
Submitter Name and Address:
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
Primary Contact:
Kate Oelberg, Senior Staff Quality and Regulatory Affairs Email: kmoelberg@beckman.com Phone: (612) 431-7315
Alternate Contact:
Kuljeet Kaur, Requlatory Affairs Manager Email: kkaur@beckman.com Office Phone: (952) 465-1914
Trade Name: Access Myoglobin Common Name: Myoqlobin Classification Regulation: 21 CFR 866.5680 Classification Product Code: DDR
Predicate Device:
Access Myoglobin 510(k) Number K021229
Device Description
The Access Myoglobin assay is a sandwich immunoenzymatic assay. The Access Myoglobin assay consists of the reagent pack and calibrators. Other items needed to run the assay include substrate and wash buffer. The Access Myoqlobin assay reagent pack, Access Myoqlobin assay calibrators, along with the UniCel Dxl Wash Buffer II are designed for use with the Dxl 9000 Access Immunoassay Analyzer in a clinical laboratory setting.
Intended Use
The Access Myodobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of myoglobin levels in human serum and plasma using the Access Immunoassay Systems to aid in the diagnosis of heart or renal disease.
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Comparison of Technological Characteristics to the Predicate (Assay)
| System
Attribute/Characteristic | Predicate Access Myoglobin
assay (K021229) run on the
Access 2 Immunoassay
System | Access Myoglobin assay run
on the Dxl 9000 Access
Immunoassay Analyzer
Instrument |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Intended Use/
Indications for Use | The Access Myoglobin assay
is a paramagnetic particle,
chemiluminescent
immunoassay for the
quantitative
determination of myoglobin
levels in human serum and
plasma using the Access
Immunoassay Systems. | Same |
| Assay Principles | The Access Myoglobin assay
is 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. | Same |
| Solid Support | Paramagnetic Particles | Same |
| Detection System | Utilizes dioxetane-based
chemiluminescent substrate;
Measures light production from
a chemiluminescent reaction | Same |
| Calibrators | Liquid calibrators prepared
from buffered bovine protein
matrix and human skeletal
Myoglobin at various levels | Same |
| Sample Type | Serum/Plasma (heparin or
EDTA) | Same |
| Measuring Range | 1 - 4000 ng/mL | 3.0 - 4000 ng/mL |
| Expected Results | Separate ranges for Heparin
plasma/serum vs EDTA
plasma | Same ranges |
| Instrument | Access Immunoassay system | Dxl 9000 Access
Immunoassay Analyzer |
| Substrate | Access Substrate | Lumi-Phos PRO substrate |
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Standard/Guidance Document Referenced (if applicable):
CLSI EP05-A3: Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Third Edition
CLSI EP06-2nd Edition : Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline
CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures: Approved Guideline - Second Edition
CLSI EP09c: Measurement Procedure Comparison and Bias Estimation Using Patient Samples-Third Edition
CLSI EP28-A3c Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory - Third Edition
CLSI EP35 Assessment of Equivalence of Suitability of Specimen Types for Medical Laboratory Measurement Procedures - First Edition
Summary of Studies:
Method Comparison:_A study based on CLSI EP09c, 3rd Edition using Weighted Deming regression and Pearson's correlation compared the Access 2 Immunoassay System and the Dxl 9000 Access Immunoassay Analyzer.
| N | Concentratio
n Range*
(ng/mL) | Slope | Slope
95% CI | Intercept | Intercept
95% CI | R |
|-----|-------------------------------------|-------|-----------------|-----------|---------------------|------|
| 155 | 8.2 – 3900 | 0.99 | 0.98 – 1.00 | 0.47 | -0.10 – 1.0 | 1.00 |
*Range is Access 2 values
Imprecison: The assay was designed to have within-laboratory imprecision as listed below:
≤ 1.10 ng/mL (µg/L) SD at concentrations ≤ 11.0 ng/mL (µg/L)
≤ 10.0% CV at concentrations > 11.0 ng/mL (uq/L)
A study based on CLSI EP05-A3 performed on the Dxl 9000 Access Immunoassay Analyzer tested multiple samples in duplicate in 2 runs per day for a minimum of 20 days.
| ng/mL (µg/L) | | Repeatability
(Within-Run) | | Between-Run | | Between-Day | | Within-
Laboratory | | |
|--------------|----|-------------------------------|------|-------------|------|-------------|------|-----------------------|-------|-----|
| Sample | N | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Sample 1 | 80 | 7.9 | 0.18 | 2.3 | 0.18 | 2.2 | 0.17 | 2.2 | 0.31 | 3.9 |
| Sample 2 | 80 | 101 | 2.2 | 2.1 | 4.0 | 4.0 | 3.0 | 3.0 | 5.5 | 5.4 |
| Sample 3 | 80 | 465 | 8.0 | 1.7 | 15.1 | 3.2 | 0.0 | 0.0 | 17.0 | 3.7 |
| Sample 4 | 80 | 1763 | 35.0 | 2.0 | 57.5 | 3.3 | 0.1 | 0.0 | 67.3 | 3.8 |
| Sample 5 | 80 | 2719 | 54.8 | 2.0 | 85.9 | 3.2 | 0.0 | 0.0 | 101.9 | 3.7 |
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Linearity: A study based on CLSI EP06-Ed2 performed on the Dxl 9000 Access Immunoassay Analyzer determined the assay demonstrated linearity across the measuring interval.
Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ): Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ) studies were conducted on the Dxl 9000 Access Immunoassay Analyzer following CLSI guideline EP17-A2 The LoB study included multiple reagent lots and 3 instruments over a minimum of 3 days. The LoD and LoQ studies included multiple reagent lots and 3 instruments over a minimum of 5 days.
| ng/mL (μg/L) | |
|---|---|
| Limit of Blank (LoB) | 3.0 |
| Limit of Detection (LoD) | 3.0 |
| Limit of Quantitation (LoQ) | |
| ≤ 20% within-lab CV | 3.0 |
Substantial Equivalence Comparison Conclusion
Beckman Coulter's Access Myoglobin assay on the Dxl 9000 Access Immunoassay Analyzer is substantially equivalent to Myoglobin assay on the Access Immunoassay System (K021229) as demonstrated through the information and data provided in this submission. The performance testing presented in this submission provides evidence that the device is safe and effective in its intended use.