(62 days)
Not Found
No
The device description and performance studies describe a standard clinical chemistry assay based on a chemical reaction and absorbance measurement, with no mention of AI or ML.
No
This device is an in vitro diagnostic assay used for the quantitative determination of creatinine in human samples, aiding in the diagnosis and monitoring of renal diseases. It does not provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis," indicating its role in diagnosis. The "Device Description" also labels it "an in vitro diagnostic assay."
No
The device description clearly states it is an "in vitro diagnostic assay" that involves a chemical reaction with a sample (serum, plasma, or urine) and measures absorbance at a specific wavelength (500 nm). This indicates a physical, chemical, and optical process, not solely 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 creatinine in human serum, plasma, or urine and that these measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis. This clearly indicates a diagnostic purpose using samples taken from the human body.
- Device Description: The "Device Description" further confirms 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 (outside the body) to perform the test.
- Performance Studies: The performance studies describe testing the assay's performance using control materials and comparing it to a predicate device, which is typical for IVD submissions.
The definition of an IVD is a medical device that is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment. This device fits that definition perfectly.
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
C6X
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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human serum, plasma, or urine
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
Comparative performance studies were conducted using the AEROSET™ System. The Creatinine assay method comparison yielded acceptable correlation with the Boehringer Mannheim Creatinine assay on the Hitachi 717 Analyzer for the serum and urine applications. For the serum application, the correlation coefficient = 0.9997, slope = 0.873, and Y-intercept = 0.078 mg/dL. For the urine applications, the correlation coefficient = 0.9947, slope = 1.056, and Y-intercept = -2.410 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 101 is 3.0% and Level 2/Panel 102 is 2.6%. For the urine application, the total %CV for Level 1/Panel 201 is 1.6% and Level 2/Panel 202 is 2.1%. The Creatinine assay is linear up to 38.7 mg/dL for the serum application, and 757.0 mg/dL for the urine application. The limit of quantitation (sensitivity) of the Creatinine assay is 0.10 mg/dL. These data demonstrate that the performance of the Creatinine assay is substantially equivalent to the performance of the Boehringer Mannheim Creatinine assay on the Hitachi 717 Analyzer for the serum and urine applications.
Key Metrics
For the serum application, the correlation coefficient = 0.9997, slope = 0.873, and Y-intercept = 0.078 mg/dL. For the urine applications, the correlation coefficient = 0.9947, slope = 1.056, and Y-intercept = -2.410 mg/dL. For the serum application, the total %CV for Level 1/Panel 101 is 3.0% and Level 2/Panel 102 is 2.6%. For the urine application, the total %CV for Level 1/Panel 201 is 1.6% and Level 2/Panel 202 is 2.1%. The Creatinine assay is linear up to 38.7 mg/dL for the serum application, and 757.0 mg/dL for the urine application. The limit of quantitation (sensitivity) of the Creatinine assay is 0.10 mg/dL.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
510(k) Summary
K981799
July 22, 1998
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) 518-6062 Fax (972) 753-3367
| Date of Preparation of this Summary: | May 20, 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 Boehringer Mannheim® Creatinine assay on the Hitachi® 717 Analyzer (K812095) for the serum, plasma, or urine applications .
Creatinine 510(k) May 20, 1998 Creatf.lwp
Section II
Page
0000011
1
These assays vield similar Performance Characteristics.
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 vield 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 AEROSET™ System. The Creatinine assay method comparison yielded acceptable correlation with the Boehringer Mannheim Creatinine assay on the Hitachi 717 Analyzer for the serum and urine applications. For the serum application, the correlation coefficient = 0.9997, slope = 0.873, and Y-intercept = 0.078 mg/dL. For the urine applications, the correlation coefficient = 0.9947, slope = 1.056, and Y-intercept = -2.410 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 101 is 3.0% and Level 2/Panel 102 is 2.6%. For the urine application, the total %CV for Level 1/Panel 201 is 1.6% and Level 2/Panel 202 is 2.1%. The Creatinine assay is linear up to 38.7 mg/dL for the serum application, and 757.0 mg/dL for the urine application. The limit of quantitation (sensitivity) of the Creatinine assay is 0.10 mg/dL. These data demonstrate that the performance of the Creatinine assay is
Creatinine 510(k) May 20, 1998 Creatflwp
Section II Page 2
namni 2
2
substantially equivalent to the performance of the Boehringer Mannheim Creatinine assay on the Hitachi 717 Analyzer for the serum and urine applications.
Conclusion:
The Creatinine assay is substantially equivalent to the Boehringer Mannheim Creatinine assay on the Hitachi 717 Analyzer for the serum and urine applications as demonstrated by results obtained in the studies
Creatinine 510(k)
May 20, 1998 Creatf.lwp
Section II
Page 3
34
0000012
3
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 22 1998
Mark Littlefield Mark British Manager, Regulatory Affairs Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038
K981799 Re : Crea Requlatory Class: II Product Code: CGX Dated: May 20, 1998 Received: May 21, 1998
Dear Mr. Littlefield:
We have reviewed your Section 510(k) notification of intent to we have reviewed jeeferenced above and we have determined the market 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 requlation (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 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 requlations.
4
Page 2
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 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
5
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
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.
Sign-Off)
Clinical Laboratory Devices
O(k) Number K981799
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concarrence of CDRH, Office of Device Evaluation (ODE) Prescription Use Over-The-Counter Use ----OR (Per 21 CFR 801.109)
(Optional Format 1-2-96)