(167 days)
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No
The device description details a standard clinical chemistry assay based on enzymatic reactions and spectrophotometric measurement. There is no mention of AI, ML, image processing, or any data-driven algorithms beyond basic statistical analysis for performance evaluation.
No
This device is an in vitro diagnostic assay used for the quantitative determination of creatine kinase in human serum or plasma, which aids in diagnosis and treatment, but it does not directly perform any therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the "Measurement of creatine kinase is used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy." This indicates its role in disease diagnosis.
No
The device is an in vitro diagnostic assay, which is a chemical reagent kit used with a specific instrument (AEROSET™) to measure a substance in a biological sample. This involves physical components (reagents) and a hardware instrument, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is used for the quantitation of creatine kinase in human serum or plasma. This indicates that the test is performed on samples taken from the human body.
- Device Description: The "Device Description" further clarifies that it is an in vitro diagnostic assay for the quantitative determination of creatine kinase in human serum or plasma. It describes the biochemical reactions that occur outside the body to measure the analyte.
- Purpose: The measurement of creatine kinase is used in the diagnosis and treatment of medical conditions (myocardial infarction and muscle diseases). This aligns with the purpose of IVD devices, which are used to provide information for diagnostic or therapeutic purposes.
The information provided clearly indicates that this device is designed to be used in vitro (outside the living organism) to analyze human biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Creatine Kinase assay is used for the quantitation of creatine kinase in human serum or plasma on the AEROSET™ instrument.
Measurement of creatine kinase is used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
Product codes (comma separated list FDA assigned to the subject device)
75 CGS
Device Description
Creatine Kinase is an in vitro diagnostic assay for the quantitative determination of creatine kinase in human serum or plasma. The Creatine Kinase assay is a clinical chemistry assay in which the creatine kinase present in the sample catalyzes the transfer of a high energy phosphate group from creatine phosphate to ADP. The ATP produced in this reaction is subsequently used to phosphorylate glucose to produce glucose-6-phosphate (G-6-P) in the presence of hexokinase. G-6-P is then oxidized by glucose-6-phosphate dehydrogenase (G-6-PDH) with the concomitant reduction of NADP to NADPH. The rate of formation of NADPH is monitored at 340 nm and is proportional to the activity of creatine kinase in the sample.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative performance studies were conducted using the AEROSET™ System. The Creatine Kinase assay method comparison yielded acceptable correlation with the Boehringer Mannheim CK/NAC assay on the Hitachi 717 Analyzer. The correlation coefficient = 0.999, slope = 0.988, and Y -intercept = - 0.829 U/L. Precision studies were conducted using the Creatine Kinase assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 101 is 3.5% and Level 2/Panel 102 is 4.6%. The Creatine Kinase assay is linear up to 7,150 U/L. The limit of quantitation (sensitivity) for the Creatine Kinase assay is 4.7 U/L. These data demonstrate that the performance of the Creatine Kinase assay is substantially equivalent to the performance of the Boehringer Mannheim CK/NAC assay on the Hitachi 717 Analyzer.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
correlation coefficient = 0.999, slope = 0.988, Y -intercept = - 0.829 U/L, total %CV for Level 1/Panel 101 is 3.5%, total %CV for Level 2/Panel 102 is 4.6%, linear up to 7,150 U/L, limit of quantitation (sensitivity) for the Creatine Kinase assay is 4.7 U/L.
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).
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§ 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
2/16/99
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510(k) Summary
Submitter's Name/Address
Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038 Contact Person Linda Morris Senior Regulatory Specialist MS 1-8 Regulatory Affairs (972) 518-6711 Fax (972) 753-3367
| Date of Preparation of this Summary: | September 1, 1998 |
|---|---|
| Device Trade or Proprietary Name: | CK |
| Device Common/Usual Name or Classification Name: | Creatine Kinase |
| Classification Number/Class: | Class II |
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:
Test Description:
Creatine Kinase is an in vitro diagnostic assay for the quantitative determination of creatine kinase in human serum or plasma. The Creatine Kinase assay is a clinical chemistry assay in which the creatine kinase present in the sample catalyzes the transfer of a high energy phosphate group from creatine phosphate to ADP. The ATP produced in this reaction is subsequently used to phosphorylate glucose to produce glucose-6-phosphate (G-6-P) in the presence of hexokinase. G-6-P is then oxidized by glucose-6-phosphate dehydrogenase (G-6-PDH) with the concomitant reduction of NADP to NADPH. The rate of formation of NADPH is monitored at 340 nm and is proportional to the activity of creatine kinase in the sample.
Creatine Kinase 510(k) September 1, 1998 CK_5_V1.lwp
Section II Page 1
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Substantial Equivalence:
The Creatine Kinase assay is substantially equivalent to the following device: Boehringer Mannheim® CK/NAC assay (K782156) on the Hitachi® 717 Analyzer. Both assays vield similar Performance Characteristics.
Similarities:
- . Both assays are in vitro clinical chemistry methods.
- Both assays can be used for the quantitative determination of creatine kinase. .
- . Both assays yield similar clinical results.
Differences:
- . There is a difference between the assay range.
Intended Use:
The Creatine Kinase assay is used for the quantitation of creatine kinase in human serum or plasma on the AEROSET™ instrument.
Performance Characteristics:
Comparative performance studies were conducted using the AEROSET™ System. The Creatine Kinase assay method comparison vielded acceptable correlation with the Boehringer Mannheim CK/NAC assay on the Hitachi 717 Analyzer. The correlation coefficient = 0.999, slope = 0.988, and Y -intercept = - 0.829 U/L. Precision studies were conducted using the Creatine Kinase assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 101 is 3.5% and Level 2/Panel 102 is 4.6%. The Creatine Kinase assay is linear up to 7,150 U/L. The limit of quantitation (sensitivity) for the Creatine Kinase assay is 4.7 U/L. These data demonstrate that the performance of the Creatine Kinase assay is substantially equivalent to the performance of the Boehringer Mannheim CK/NAC assay on the Hitachi 717 Analyzer.
Creatine Kinase 510(k) September 1, 1998 CK_S_VI lwp
Section II Page 2
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Conclusion:
The Creatine Kinase assay is substantially equivalent to the Boehringer Mannheim CK/NAC assay on the Hitachi 717 Analyzer as demonstrated by results obtained in the studies.
Creatine Kinase 510(k) September 1, 1998
CK_5_VI.Iwp
Section II
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Public Health Service
FEB 1 6 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Linda Morris Senior Requlatory Specialist Abbott Laboratories 1920 Hurd Drive 75038 Irving, Texas
Re : K983070 Trade Name: Creatine Kinase Requlatory Class: II Product Code: 75 CGS December 28, 1998 Dated: December 29, 1998 Received:
Dear Ms. Morris:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You mav. 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 aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Creatine Kinase Device Name:
Indications For Use:
The Creatine Kinase assay is used for the quantitation of creatine kinase in human serum or plasma on the AEROSET™ instrument. Measurement of creatine kinase is used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
Veronica Dahluia for Jair Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K983070/51
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use_ Prescription Use / OR (Per 21 CFR 801.109)
(Optional Format 1-2-96)
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Creatine Kinase 510(k) September 1, 1998 CK_5_VI.lwp