(364 days)
Not Found
No
The summary describes a standard immunoassay system for measuring myoglobin levels and does not mention any AI or ML components. The performance studies focus on imprecision, which is typical for this type of assay.
No
This device is for the quantitative determination of myoglobin levels to aid in the diagnosis of heart and renal diseases, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurement of myoglobin aids in the rapid diagnosis of heart and renal diseases." This indicates a diagnostic purpose.
No
The device description explicitly states that the system comprises reagent, calibrators, and immunoassay analyzers, which are hardware components.
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 involves testing biological samples in vitro (outside the body).
- Device Description: The description mentions "reagent and calibrators" and "Immunoassay Analyzers," which are components typically used in laboratory settings for in vitro testing.
- Measurement of Biomarkers: The assay measures myoglobin, a biomarker in human samples, to aid in the diagnosis of diseases. This is a core function of IVDs.
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.
Measurement of myoglobin aids in the rapid diagnosis of heart and renal diseases.
Product codes (comma separated list FDA assigned to the subject device)
DDR, JIS
Device Description
The Access Myoglobin reagent and calibrators, the Access Immunoassay Analyzers comprise the Access Immunoassay Systems for the quantitative determination of cardiac Myoglobin in human serum and plasma.
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)
Imprecision: Within-run assay imprecision was tested for concentrations from approximately 79 to 2405 ng/mL. The within-run imprecision ranged from 3.05 % CV to 4.32% CV. Between-run assay imprecision ranged from 6.49% CV to 8.58% CV. Total imprecision ranged from 7.32% CV to 9.25% CV.
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.
Access Myoglobin Assay - K021229
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
§ 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
FEB 2 0 2009
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: K080481
| Applicant: | Beckman Coulter, Inc.
1000 Lake Hazeltine Drive
Chaska, MN 55318 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Rachelle Parsons
Senior Regulatory Affairs Specialist, RAC
Phone: 952.368.1227
Fax: 952.368.7610 |
| Date prepared: | August 20, 2008 |
| Proprietary name: | Access ® Myoglobin and Access Myoglobin Calibrators on
the Access Immunoassay Systems |
| Common name: | Myoglobin Enzyme Immunoassay |
| Product classification: | Class II |
| Product code: | DDR; JIS |
| Predicate device: | Access Myoglobin Assay - K021229 |
| Device description: | The Access Myoglobin reagent and calibrators, the Access
Immunoassay Analyzers 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 myoglobin levels in human serum and
plasma using the Access Immunoassay Systems. |
1
Comparison of Technological Characteristics
| Attribute | Access Myoglobin | Access Myoglobin
(With Modification to IFU) |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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, mouse
monoclonal anti-myoglobin-
biotin conjugate, and
paramagnetic particles coated
with goat anti-biotin |
| Solid Support | Paramagnetic particles. | Paramagnetic particles. |
| Detection System | Chemiluminescent substrate. | Chemiluminescent substrate. |
| Calibrator | Liquid calibrators (frozen)
prepared from buffered bovine
serum albumin matrix with
human cardiac Myoglobin at
specified levels | Liquid calibrators (frozen)
prepared from buffered bovine
serum albumin matrix with
human cardiac Myoglobin at
specified levels |
| Analytical Range | 1-4000ng/mL | 1-4000ng/mL |
| Imprecision | This assay exhibits total
imprecision of less than 8%
across the expected
physiological range. | This assay exhibits total
imprecision of ≤ 10% across
the expected physiological
range. |
Summary of Precision Study
Imprecision: Within-run assay imprecision was tested for concentrations from approximately 79 to 2405 ng/mL. The within-run imprecision ranged from 3.05 % CV to 4.32% CV. Between-run assay imprecision ranged from 6.49% CV to 8.58% CV. Total imprecision ranged from 7.32% CV to 9.25% CV.
2
Conclusion
Imprecision was the only performance characteristic revised in the Access Myoglobin assay and was not found to impact the safety and efficacy of the device. The modified Access® Myoglobin assay is substantially equivalent to the previously cleared Access® Myoglobin assay. .
. . . . . . .
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Beckman Coulter, Inc. c/o Ms. Rachelle Parsons Senior Regulatory Affairs Specialist, RAC 1000 Lake Hazeltine Drive Chaska, MN 55318
FEB 2 0 2009
Re: K080481
Trade/Device Name: Access® Myoglobin and Access Myoglobin Calibrators on the Access Immunoassay Systems
Regulation Number: 21 CFR §866.5680 Regulation Name: Myoglobin Immunological Test System. Regulatory Class: Class II Product Code: DDR, JIT Dated: February 16, 2009 Received: February 17, 2009
Dear Ms. Parsons:
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 adalteration.
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 (OS) regulation (21 CFR Part 820).
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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,
Coy C. H
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
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Indication for Use
510(k) Number (if known): K080481
Device Name:
Access Myoglobin and Access Myoglobin Calibrators on the Access® Immunoassay Systems
Indication For Use:
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, . . -- --:
Measurement of myoglobin aids in the rapid diagnosis of heart and renal diseases.
Prescription Use × (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safely (O)VD);
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(K) K 7804