(56 days)
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No
The device description details a chemical reaction and spectrophotometric measurement, which are traditional laboratory techniques, not AI/ML. There are no mentions of AI, DNN, or ML in the provided text.
No
The device is an in vitro diagnostic assay used to measure creatinine levels, which aids in diagnosis and monitoring, but does not provide treatment.
Yes
The 'Intended Use / Indications for Use' section explicitly states, "Creatinine measurements are used in the diagnosis and treatment of renal diseases." The 'Device Description' also identifies it as an "in vitro diagnostic assay."
No
The device description clearly outlines a chemical reaction and measurement of absorbance at a specific wavelength, indicating a physical in vitro diagnostic assay that requires hardware components.
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 device is "intended to measure creatinine levels in serum, plasma, and urine." It also mentions that these measurements are "used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes." This clearly indicates that the device is used to analyze samples taken from the human body to provide information for medical purposes.
- Device Description: The "Device Description" further clarifies that it is an "in vitro diagnostic assay for the quantitative analysis of creatinine in human serum, plasma, or urine." The description of the chemical reaction (creatinine reacting with picrate) confirms that the analysis is performed in vitro (outside the living body) on biological samples.
- Performance Studies: The "Summary of Performance Studies" describes comparative studies and precision studies conducted on the assay, which are typical evaluations for IVD devices to demonstrate their accuracy and reliability.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K941837; Roche Creatinine assay on the Hitachi 917 Analyzer) is a strong indicator that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.
All these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A Creatinine test system is a device intended to measure creatinine levels in serum, plasma, and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
Product codes (comma separated list FDA assigned to the subject device)
CGX
Device Description
Creatinine is an in vitro diagnostic assay for the quantitative analysis of creatinine in human serum, plasma, or urine. At an alkaline pH, creatinine in the sample reacts with picrate to form a creatinine-picrate complex. The rate of increase in absorbance at 500 nm due to the formation of this complex is directly proportional to the concentration of creatinine 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 systems. The Creatinine assay method comparison yielded acceptable correlation with the Creatinine assay on the Hitachi 917 Analyzer. The AEROSET System showed a correlation coefficient of 0.9996, slope of 0.98, and Y-intercept of -0.19 mg/dL for the serum application and a correlation coefficient of 0.9992, slope of 0.94, and Y-intercept of -3.66 mg/dL for the urine application when compared to the Hitachi 917 Analyzer. The ARCHITECT c8000 System showed a correlation coefficient of 0.9993, slope of 0.96, and Y-intercept of -0.24 mg/dL for the serum application and a correlation coefficient of 0.9990, slope of 0.93, and Y-intercept of -4.16 mg/dL for the urine application when compared to the Hitachi 917 Analyzer. The ARCHITECT c8000 System showed a correlation coefficient of 0.9996, slope of 0.98, and Y-intercept of -0.06 mg/dL for the serum application and a correlation coefficient of 0.9997, slope of 0.99, and Y-intercept of -0.51 mg/dL for the urine application when compared to the AEROSET System. The Creatinine assay method comparison yielded acceptable correlation between the AEROSET System and the ARCHITECT c8000 System.
Precision studies were conducted using the Creatinine assay. On the AEROSET System, the total %CV for Level 1 is 4.95%, and Level 2 is 3.18% for the serum application and the total %CV for Level 1 is 2.41%, and Level 2 is 2.41% for the urine application. On the ARCHITECT c8000 System, the total %CV for Level 1 is 3.10%, and Level 2 is 1.54% for the serum application and the total %CV for Level 1 is 0.94%, and Level 2 is 0.99% for the urine application.
The Creatinine assay is linear from 0.20 to 37.00 mg/dL for the serum application. The Creatinine assay is linear from 5.0 to 740.0 mg/dL for the urine application. The limit of quantitation (sensitivity) of the Creatinine assay is 0.10 mg/dL for the serum application, and 2.0 mg/dL for the urine application.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The limit of quantitation (sensitivity) of the Creatinine assay is 0.10 mg/dL for the serum application, and 2.0 mg/dL for the urine application.
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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§ 862.1225 Creatinine test system.
(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.(b)
Classification. Class II.
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510(k) Summary
| Submitter's Name/Address | Contact Person |
|---|---|
| Abbott Laboratories | Linda Morris |
| 1921 Hurd Drive | Senior Regulatory Specialist, MS 2-11 |
| Irving, TX 75038 | Regulatory Affairs |
| (972) 518-6711 | |
| Fax (972) 518-7479 |
| Date of Preparation of this Summary: | April 26, 2006 |
|---|---|
| Device Trade or Proprietary Name: | Creatinine |
| Device Common/Usual Name or | |
| Classification Name: | Creatinine |
| Classification Number/Class: | Class II 862.1125 |
| Product Code: | CGX |
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: K 06 11 93
Test Description:
Creatinine is an in vitro diagnostic assay for the quantitative analysis of creatinine in human serum, plasma, or urine. At an alkaline pH, creatinine in the sample reacts with picrate to form a creatinine-picrate complex. The rate of increase in absorbance at 500 nm due to the formation of this complex is directly proportional to the concentration of creatinine in the sample.
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Substantial Equivalence:
The Creatinine assay is substantially equivalent to the Roche Creatinine assay (K941837) on the Hitachi 917 Analyzer. Both assays yield similar Performance Characteristics.
Similarities:
- . Both assays can be used for the quantitation of creatinine,
- . Both assays yield similar results.
- Both assays are based on the modified Jaffe (creatinine alkaline picrate) methodology. .
- Both assays use serum, plasma, and urine .
Differences:
None
Intended Use:
The Creatinine assay is used for the quantitation of creatinine in human serum, plasma, or urine.
Performance Characteristics:
Comparative performance studies were conducted using the AEROSET® System. The Creatinine assay method comparison yielded acceptable correlation with the Creatinine assay on the Hitachi 917 Analyzer. The AEROSET System showed a correlation coefficient of 0.9996, slope of 0.98, and Y-intercept of - 0.19 mg/dL for the serum application and a correlation coefficient of 0.9992, slope of 0.94, and Y-intercept of - 3.66 mg/dL for the urine application when compared to the Hitachi 917 Analyzer. The ARCHITECT c8000 System showed a correlation coefficient of 0.9993, slope of 0.96, and Y-intercept of - 0.24 mg/dL for the serum application and a correlation coefficient of 0.9990, slope of 0.93, and Y-intercept of - 4.16 mg/dL for the urine application when compared to the Hitachi 917 Analyzer. The ARCHITECT c8000 System showed a correlation coefficient of 0.9996, slope
Creatinine - Conc. 510(k) - R2 June 13, 2006
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of 0.98, and Y-intercept of - 0.06 mg/dL for the serum application and a correlation coefficient of 0.9997, slope of 0.99, and Y-intercept of - 0.51 mg/dL for the urine application when compared to the AEROSET System. The Creatinine assay method comparison vielded acceptable correlation between the AEROSET System and the ARCHITECT c8000 System.
Precision studies were conducted using the Creatinine assay. On the AEROSET System, the total %CV for Level 1 is 4.95%, and Level 2 is 3.18% for the serum application and the total %CV for Level 1 is 2.41%, and Level 2 is 2.41% for the urine application. On the ARCHITECT c8000 System, the total %CV for Level 1 is 3.10%, and Level 2 is 1.54% for the serum application and the total %CV for Level 1 is 0.94%, and Level 2 is 0.99% for the urine application.
The Creatinine assay is linear from 0.20 to 37.00 mg/dL for the serum application. The Creatinine assay is linear from 5.0 to 740.0 mg/dL for the urine application. The limit of quantitation (sensitivity) of the Creatinine assay is 0.10 mg/dL for the serum application, and 2.0 mg/dL for the urine application.
These data demonstrate that the performance of the Creatinine assay is substantially equivalent to the performance of the Creatinine assay on the Hitachi 917 Analyzer.
Conclusion:
The Creatinine assay on the AEROSET and the ARCHITECT c8000 Systems is substantially equivalent to the Roche Creatinine assay on the Hitachi 917 Analyzer as demonstrated by results obtained in the studies.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows a black and white logo of the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the text "U.S. Department of Health and Human Services, USA" is arranged in a circular pattern around the eagle. The eagle is depicted in a minimalist style, with simple lines forming its body and wings.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 3 2006
Ms. Linda Morris Sr. Regulatory Specialist ADD Regulatory Affairs Abbott Laboratories Inc. 1921 Hurd Drive Irving, TX 75038
Re: K061193
Trade/Device Name: Abbott Clinical Chemistry Creatinine Regulation Number: 21 CFR§862.1225 Regulation Name: Creatine test system Regulatory Class: Class II Product Code: CGX Dated: April 26, 2006 Received: April 28. 2006
Dear Ms. Morris:
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 (D114). 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 misbrandi, noand 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 EDA 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 maurements not hit . . cr 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 proctice requirements as set forth in the quality systems (QS) regulation (21 CFR Party 800).
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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 (240) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Alberto Gutt
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Abbott Clinical Chemistry Creatinine
Indications For Use:
A creatinine test system is a device intended to measure creatinine levels in serum. plasma, and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
G.C.
-nos of in Vitro Diagnostic 1 . duation and Safi
042 K001493
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