(15 days)
Not Found
No
The summary describes a standard immunoassay for measuring CK-MB 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) device used to measure CK-MB levels, which aids in the diagnosis and treatment (monitoring) of myocardial infarction. It does not provide therapy itself.
Yes
The 'Intended Use / Indications for Use' section explicitly states, "Measurement of creatine kinase is used in the diagnosis and treatment of myocardial infarction." This indicates its role in disease diagnosis, fulfilling the definition of a diagnostic device.
No
The device description explicitly states that the system comprises reagents, calibrators, and immunoassay analyzers (hardware), in addition to the assay itself. This indicates it is a system involving both hardware and software/reagents, 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 CK-MB levels in human serum and plasma." This involves testing biological samples in vitro (outside the body).
- Device Description: It describes "reagents, calibrators, and the Access Immunoassay Analyzers" which are components used to perform tests on biological samples.
- Purpose: The measurement of CK-MB is used in the "diagnosis and treatment of myocardial infarction," which is a medical purpose achieved through in vitro testing.
- Performance Studies: The summary of performance studies details analytical studies like precision, sensitivity, linearity, and method comparison, all of which are standard evaluations for in vitro diagnostic assays.
- Reference Intervals: The establishment of reference intervals for serum and plasma further indicates its use in interpreting in vitro test results for clinical purposes.
N/A
Intended Use / Indications for Use
The Access CK-MB assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CK-MB levels in human serum and plasma using the Access Immunoassay Systems. Measurement of creatine kinase is used in the diagnosis and treatment of myocardial infarction.
Product codes (comma separated list FDA assigned to the subject device)
JHX, JIS
Device Description
The Access CK-MB reagents, calibrators, and the Access Immunoassay Analyzers (Access, Access 2, and Synchron LXi 725) comprise the Access Immunoassay Systems for the quantitative determination of CK-MB 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)
Precision: Within run imprecision ranged from 1.15%CV to 2.32%CV, between-run imprecision ranged from 1.47%CV to 2.89%CV and total imprecision ranged from 2.66%CV to 3.54%CV at levels ranging between 4.5 and 172.3 ng/mL.
Analytical Sensitivity: The lowest detectable level of CK-MB distinguishable from zero (Access CK-MB calibrator S0) with 95% confidence is
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a black circle with two white curved lines inside, resembling a stylized eye. To the right of the circle, the words "BECKMAN" and "COULTER" are stacked on top of each other in a bold, sans-serif font.
JAN 1 7 2003
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:
Submitter's Name and Address
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 Telephone: (952)368-1323 Fax: (952)368-7610 Contact: Brent Taber
Date Prepared: December 31, 2002
Device Names
| Proprietary Name: | CK-MB and CK-MB Calibrators on the Access®
Immunoassay Systems |
| ------------------- | ------------------------------------------------------------------- |
|---|
- Common Name: CK-MB Enzyme Immunoassay
Classification Name: Fluorometric Method, CPK or Isoenzymes
Predicate Device
Access® CK-MB Assay for Use on the Access® Immunoassay Analyzer Beckman Coulter, Inc. Chaska, MN 55318
510(k) Number: K000716
1
Image /page/1/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized black 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 modern.
Device Description
The Access CK-MB reagents, calibrators, and the Access Immunoassay Analyzers (Access, Access 2, and Synchron LXi 725) comprise the Access Immunoassay Systems for the quantitative determination of CK-MB in human serum and plasma.
Intended Use
The Access CK-MB assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CK-MB levels in human serum and plasma using the Access Immunoassay Systems.
| Attribute | Current Access CK-MB | Modified Access CK-MB |
|---|---|---|
| Intended | ||
| Use | For the measurement of | |
| CK-MB in human serum and | ||
| plasma | For the measurement of | |
| CK-MB in human serum and | ||
| plasma | ||
| Assay | ||
| Principles | Utilizes the binding of | |
| CK-MB to specific monoclonal | ||
| antibodies in a two site | ||
| "sandwich" immunoassay; | ||
| Utilizes alkaline phosphatase | ||
| enzyme conjugated to | ||
| monoclonal antibody | Utilizes the binding of | |
| CK-MB to specific monoclonal | ||
| antibodies in a two site | ||
| "sandwich" immunoassay; | ||
| Utilizes alkaline phosphatase | ||
| enzyme conjugated to | ||
| monoclonal antibody | ||
| 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 prepared | |
| from buffered bovine serum | ||
| albumin matrix with | ||
| recombinant CK-MB at | ||
| specified levels | Liquid calibrators prepared | |
| from buffered bovine serum | ||
| albumin matrix with | ||
| recombinant CK-MB at | ||
| specified levels |
Comparison of Technological Characteristics
2
Image /page/2/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized black oval shape on the left, with two curved white lines running through it. To the right of the oval is the company name, "BECKMAN COULTER," written in a bold, sans-serif font. The text is stacked, with "BECKMAN" on top of "COULTER."
Summary of Analytical Studies
Within run imprecision ranged from 1.15%CV to 2.32%CV, Precision: between-run imprecision ranged from 1.47%CV to 2.89%CV and total imprecision ranged from 2.66%CV to 3.54%CV at levels ranging between 4.5 and 172.3 ng/mL.
Analytical Sensitivity: The lowest detectable level of CK-MB distinguishable from zero (Access CK-MB calibrator S0) with 95% confidence is Trade/Device Name: CK-MB and CK-MB Calibrators on the Access Immunoassay Systems Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system. Regulatory Class: Class II Product Code: JHX, JIS Dated: December 31, 2002 Received: January 2, 2003
Dear Mr. Taber:
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 (OS) 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) 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). Other general information on your responsibilities under the Act may be obtained 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
6
INDICATIONS FOR USE STATEMENT
Page / of /
510(k) Number (if known): K030012
Device Name: CK-MB and CK-MB Calibrators on the Access® Immunoassay Systems
Indications For Use:
The Access CK-MB assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CK-MB levels in human serum and plasma using the Access Immunoassay Systems. Measurement of creatine kinase is used in the diagnosis and treatment of myocardial infarction.
Han Coogen
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K030012
(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) X
OR
Over-The Counter Use
(Optional Format 1-2-96)