(42 days)
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No
The summary describes a laboratory test kit for measuring enzyme activity using chemical reagents. There is no mention of AI, ML, image processing, or any computational analysis that would suggest the use of these technologies. The performance studies focus on standard analytical chemistry metrics like correlation and precision.
No
The device is intended to measure the activity of an enzyme, which is a diagnostic function, not a therapeutic one.
Yes
The device is intended to measure the activity of an enzyme in serum, which is then used to assess cardiac and skeletal muscle diseases. This falls under the definition of a diagnostic device as it provides information for the diagnosis of diseases.
No
The device description clearly states the device is a "test kit" comprised of two reagents, indicating it is a chemical reagent-based diagnostic device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is "intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes... in serum." Measuring substances in bodily fluids (like serum) to provide information for the diagnosis, treatment, or prevention of disease is the core definition of an IVD.
- Clinical Relevance: The intended use also highlights the clinical value of measuring CK levels in the assessment of cardiac and skeletal muscle diseases, further reinforcing its diagnostic purpose.
- Device Description: The description of the device as a "test kit" comprised of reagents used to perform a measurement on a biological sample (serum) is consistent with the nature of an IVD.
Therefore, based on the provided information, the Stanbio Laboratory's Creatine Kinase (CK) Liqui-UV is clearly an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device is used for the kinetic quantitative determination of Creatine Kinase (CK) in serum.
Stanbio Laboratory's Creatine Kinase (CK) Liqui-UV 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 serum. Serum creatine kinase (CK) levels have proven valuable in the assessment of cardiac and skeletal muscle diseases, including myocardial infarction and muscular dystrophy.
Product codes (comma separated list FDA assigned to the subject device)
75JFX, CGS
Device Description
The device test kit is comprised of two reagents, CK Buffer (R1) and CK Enzyme (R2). A working reagent is prepared by combining five parts CK Buffer (R1) to one part CK Enzyme (R2).
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)
Substantial equivalency was demonstrated by method comparison. Correlation was performed between the two test kits with a correlation coefficient of 0.999 and a regression equation of y = 1.027x - 0.65. In addition, precision, linearity, sensitivity, stability and interference studies were performed on Stanbio Laboratory, Inc., version of Creatine Kinase (CK) Liqui-UV®. Catalog # 2910. Results of these tests were found to be acceptable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
correlation coefficient of 0.999
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.
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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
JUL 17 1997
510(k) SUMMARY
Submitter's Name Kirk Johnson Stanbio Laboratory, Inc. 2930 East Houston Street San Antonio, TX 78202
Tel. (210) 222-2108 Fax (210) 227-6367
Prepared By Kirk Johnson May 30, 1997
Product Name Trade name: Creatine Kinase (CK) Liqui-UV® Common name: Creatine Kinase (CK) Classification name: N-Acetyl-L-Cysteine, Creatine Kinase Class II, 75JFX
Substantial Equivalence of Device This test is substantially equivalent to : Product Name: CK/NAC Manufacturer Boehringer Mannheim
Description of Device
The device test kit is comprised of two reagents, CK Buffer (R1) and CK Enzyme (R2). A working reagent is prepared by combining five parts CK Buffer (R1) to one part CK Enzyme (R2).
Intended Use of Device The device is used for the kinetic quantitative determination of Creatine Kinase (CK) in serum.
Comparison of Devices
Both Creatine Kinase (CK) methods measure kinetically the rate of NADPH formation at a rate proportional to the CK activity.
Performance Data
Substantial equivalency was demonstrated by method comparison. Correlation was performed between the two test kits with a correlation coefficient of 0.999 and a regression equation of y = 1.027x - 0.65.
In addition, precision, linearity, sensitivity, stability and interference studies were performed on Stanbio Laboratory, Inc., version of Creatine Kinase (CK) Liqui-UV®. Catalog # 2910. Results of these tests were found to be acceptable.
LABORATORY, INC
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1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 1 7 1997
Kirk Johnson FDA Correspondent Stanbio Laboratory, Inc. 2930 E. Houston Street San Antonio, Texas 78202
Re: K972155 Creatine Kinase (CK) Liqui-UV® Requlatory Class: II Product Code: CGS Dated: May 30, 1997 Received: June 5, 1997
Dear Mr. Johnson:
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 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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 regulation 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 requlation (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 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
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):_K972155
Device Name: Creatine Kinase (CK) Liqui-UV
Indications For Use:
Stanbio Laboratory's Creatine Kinase (CK) Liqui-UV 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 serum. Serum creatine kinase (CK) levels have proven valuable in the assessment of cardiac and skeletal muscle diseases, including myocardial infarction and muscular dystrophy.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use V (Per 21 CFR 801.109)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)