(53 days)
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No
The device description and performance studies focus on a standard chemical reaction and spectrophotometric measurement, with no mention of AI or ML terms or concepts.
No.
This device is an in vitro diagnostic assay used for the quantitative determination of creatinine in human samples, which aids in the diagnosis and treatment of renal diseases and monitoring renal dialysis. It does not perform a therapeutic function on the patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Creatinine measurements are used in the diagnosis and treatment of renal diseases." The "Device Description" also clearly labels it as "an in vitro diagnostic assay."
No
The device description clearly states it is an "in vitro diagnostic assay" that involves a chemical reaction and measurement of absorbance at a specific wavelength, indicating it is a physical test kit or system, not software only.
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 creatinine in human serum, plasma, or urine." This indicates that the device is intended to be used in vitro (outside the body) to analyze human specimens.
- Device Description: The "Device Description" further clarifies that it is an "in vitro diagnostic assay for the quantitative determination of creatinine in human serum, plasma, or urine." It also describes the chemical reaction that occurs in vitro to measure creatinine levels.
- Purpose: The intended use also mentions that creatinine measurements are "used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis." This clearly indicates a medical purpose related to diagnosis and monitoring, which is a key characteristic of IVDs.
N/A
Intended Use / Indications for Use
The Creatinine assay is used for the quantitation of creatinine in human serum, plasma, or urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.
Product codes
75C6X
Device Description
Creatinine is an in vitro diagnostic assay for the quantitative determination of creatinine in human serum, plasma, or urine. The Creatinine assay is a clinical chemistry assay in which the creatinine in the sample, at an alkaline pH, 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 amount 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
Comparative performance studies were conducted using the ADCYON™ Analyzer. The Creatinine assay method comparison yielded acceptable correlation with the Roche Cobas Mira Plus Automated Chemistry System Creatinine assay for the serum application and the Boehringer Mannheim Creatinine assay on the Hitachi 717 Analyzer for the urine application. For the serum application, the correlation coefficient = 0.9993, Slope = 0.980, and Y-intercept = - 0.150 mg/dL. For the urine applications, the correlation coefficient = 0.9995, slope = 1.060, and Y-intercept = 4.637 mg/dL. Precision studies were conducted using the Creatinine assay. Within-run, between-run, and between-day studies were performed using two levels of control material. For the serum application, the total %CV for Level 1/Panel 111 is 4.5% and Level 2/Panel 112 is 2.2%. For the urine application, the total %CV for Level 1/Panel 131 is 2.1% and Level 2/Panel 132 is 2.5%. The Creatinine assay is linear up to 42 mg/dL. The limit of quantitation (sensitivity) of the Creatinine assay is 0.3 mg/dL. These data demonstrate that the performance of the Creatinine assay is substantially equivalent to the performance of the Roche Cobas Mira Plus Automated Chemistry System Creatinine assay for the serum application and the Boehringer Mannheim Creatinine assay on the Hitachi 717 Analyzer for the urine application.
Key Metrics
For the serum application, the correlation coefficient = 0.9993, Slope = 0.980, and Y-intercept = - 0.150 mg/dL. For the urine applications, the correlation coefficient = 0.9995, slope = 1.060, and Y-intercept = 4.637 mg/dL.
For the serum application, the total %CV for Level 1/Panel 111 is 4.5% and Level 2/Panel 112 is 2.2%. For the urine application, the total %CV for Level 1/Panel 131 is 2.1% and Level 2/Panel 132 is 2.5%.
The Creatinine assay is linear up to 42 mg/dL. The limit of quantitation (sensitivity) of the Creatinine assay is 0.3 mg/dL.
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
0
MAY 2 9 1998
510(k) Summary
Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038
Contact Person Mark Littlefield Section Manager MS 1-8 ADD Regulatory Affairs (972) 518-7861 Fax (972) 753-3367
| Date of Preparation of this Summary: | April 2, 1998 |
|---|---|
| Device Trade or Proprietary Name: | Crea |
| Device Common/Usual Name or Classification Name: | Creatinine |
| Classification Number/Class: | 75C6X/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:
Creatinine is an in vitro diagnostic assay for the quantitative determination of creatinine in human serum, plasma, or urine. The Creatinine assay is a clinical chemistry assay in which the creatinine in the sample, at an alkaline pH, 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 amount of creatinine in the sample.
Substantial Equivalence:
The Creatinine assay is substantially equivalent to the following devices:
- Roche® Cobas Mira® Plus Automated Chemistry System Creatinine assay . (K941837) for the serum application
Creatinine 510(k) April 3, 1998 CreatE2.lwp
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- Boehringer Mannheim® Creatinine assay on the Hitachi® 717 Analyzer . (K812095) for the urine application
These assays yield similar Performance Characteristics.
Similarities to Roche:
- Both assays are in vitro clinical chemistry methods. .
- Both assays can be used for the quantitative determination of creatinine. .
- Both assays yield similar clinical results. .
Differences to Roche:
-
There is a minor difference between the assay range. .
Similarities to Boehringer Mannheim: -
Both assays are in vitro clinical chemistry methods. .
-
Both assays can be used for the quantitative determination of creatinine. .
-
Both assays yield similar clinical results. .
Differences to Boehringer Mannheim:
- . There is a minor difference between the assay range.
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 ADCYON™ Analyzer. The Creatinine assay method comparison yielded acceptable correlation with the Roche Cobas Mira Plus Automated Chemistry System Creatinine assay for the serum application and the Boehringer Mannheim Creatinine assay on the Hitachi 717 Analyzer for the urine application. For the serum application, the correlation coefficient = 0.9993, Slope = 0.980, and Y-intercept = - 0.150 mg/dL. For the urine
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applications, the correlation coefficient = 0.9995, slope = 1.060, and
Y-intercept = 4.637 mg/dL. Precision studies were conducted using the Creatinine assay. Within-run, between-run, and between-day studies were performed using two levels of control material. For the serum application, the total %CV for Level 1/Panel 111 is 4.5% and Level 2/Panel 112 is 2.2%. For the urine application, the total %CV for Level 1/Panel 131 is 2.1% and Level 2/Panel 132 is 2.5%. The Creatinine assay is linear up to 42 mg/dL. The limit of quantitation (sensitivity) of the Creatinine assay is 0.3 mg/dL. These data demonstrate that the performance of the Creatinine assay is substantially equivalent to the performance of the Roche Cobas Mira Plus Automated Chemistry System Creatinine assay for the serum application and the Boehringer Mannheim Creatinine assay on the Hitachi 717 Analyzer for the urine application.
Conclusion:
The Creatinine assay is substantially equivalent to the Roche Cobas Mira Plus Automated Chemistry System Creatinine assay for the serum application and the Boehringer Mannheim Creatinine assay on the Hitachi 717 Analyzer for the urine application as demonstrated by results obtained in the studies.
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Image /page/2/Picture/6 description: The image shows the number 0000015. The number is written in a bold, sans-serif font. The digits are evenly spaced and aligned horizontally. The number is likely a serial number or identification code.
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized emblem resembling an eagle or bird with outstretched wings, depicted in a minimalist, abstract design.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 2 9 1998
Mark Littlefield . Section Manager, Regulatory Affairs Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038
K981240 Re: Creatinine Regulatory Class: II Product Code: CGX Dated: April 3, 1998 Received: April 6, 1998
Dear Mr. Littlefield:
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 The general controls provisions of the Act 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 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 regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. 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 regulations.
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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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Sitman
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): ____________________________________________________________________________________________________________________________________________________
Creatinine Creatinine Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Creatinine assay is used for the quantitation of creatinine in human serum, plasma, or urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.
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| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Prescription Use | ||
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
| (Optional Format 1-2-96) | ||
| (Division Sign-Off) | ||
| Division of Clinical Laboratory Devices | ||
| 510(k) Number | K 98/240 | |
| 0000007 |