(61 days)
1050702
Not Found
No
The description details a chemical reaction and spectrophotometric measurement, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is a reagent used to measure creatinine levels in biological samples, which is a diagnostic function, not a therapeutic one. It provides information for diagnosis or monitoring, but does not treat a condition.
Yes
The device measures creatinine levels to aid in monitoring renal dialysis and as a basis for measuring other urine analytes, which are diagnostic purposes for assessing kidney function and health.
No
The device description clearly outlines a chemical reagent and a procedure involving measuring color change at specific wavelengths, indicating a physical, non-software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the reagent is "intended to measure creatinine levels in serum, plasma, Sigma Diagos monitoring renal dialysis, and as a calculation basis for measuring other urine analytes." This involves testing biological samples (serum, plasma, urine) outside of the body to provide information about a person's health status (creatinine levels are indicators of kidney function).
- Device Description: The description details a procedure that involves adding a biological sample to a reagent and measuring a reaction. This is a typical process for in vitro diagnostic tests.
- Performance Studies: The document includes performance studies comparing the device to a predicate device using serum and urine samples, which is standard for demonstrating the performance of an IVD.
- Predicate Device: The mention of a "Predicate Device(s)" which is another Creatinine Reagent further confirms its classification as an IVD, as predicate devices are used for comparison in the regulatory process for IVDs.
Therefore, based on the provided information, the Sigma Diagnostics Creatinine Reagent clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Sigma Diagnostics Creatinine Reagent is intended to measure creatinine levels in serum, plasma, Sigma Diagos monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
Product codes
CGX
Device Description
Creatine is synthesized in the kidney, liver and pancreas. I It is transported in blood to other organs such as muscle and brain where it is phosphocreatine. Some free creatine in muscle is converted to creatinine daily and the amount of creatinine produced is proportional to muscle mass. In the absence of renal disease, excretion rate of creatinine in an individual is relatively constant. Therefore, measurement of creatinine clearance is useful in detecting renal disease and estimating the extent of impairment of renal function.2
The Sigma Diagnostics procedure is a modification of the Jaffe reaction3 and is highly adaptable to automation. The rate of color change following the addition of a serum, plasma or urine sample to an alkaline picrate solution is measured between 480 and 520 nm and is proportional to the creatinine concentration in the test specimen.
Mentions image processing
Not Found
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
The safety and effectiveness of the Sigma Diagnostics Creatinine Reagent, Procedure 558 is demonstrated by its substantial equivalency to Boehringer Mannheim Diagnostics Creatinine Reagent. No. 1050702. Both Creatinine test systems are used to measure creatinine concentrations in serum, plasma, or urine and the reaction principles are similar. In comparison studies against BMD using the manual procedure a correlation coefficient of 0.999 and a regression equation y = 1.11x + 0.05 was obtained with 128 serum samples. In comparison studies against BMD using the manual procedure a correlation coefficient of 0.998 and a regression equation y = 1.13x -0.17 was obtained with urine samples. With-in run precision and total precision on serum samples indicate acceptable values can be replicated on a day to day basis. Sigma Diagnostics Creatinine reagent has been determined to be linear to 25 mg/dL.
Key Metrics
correlation coefficient of 0.999, correlation coefficient of 0.998, linear to 25 mg/dL
Predicate Device(s)
No. 1050702
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
972743
SUMMARY OF SAFETY AND EFFECTIVENESS
CREATININE, PROCEDURE NO. 558
Creatine is synthesized in the kidney, liver and pancreas. I It is transported in blood to other organs such as muscle and brain where it is phosphocreatine. Some free creatine in muscle is converted to creatinine daily and the amount of creatinine produced is proportional to muscle mass. In the absence of renal disease, excretion rate of creatinine in an individual is relatively constant. Therefore, measurement of creatinine clearance is useful in detecting renal disease and estimating the extent of impairment of renal function.2
The Sigma Diagnostics procedure is a modification of the Jaffe reaction3 and is highly adaptable to automation. The rate of color change following the addition of a serum, plasma or urine sample to an alkaline picrate solution is measured between 480 and 520 nm and is proportional to the creatinine concentration in the test specimen.
The safety and effectiveness of the Sigma Diagnostics Creatinine Reagent, Procedure 558 is demonstrated by its substantial equivalency to Boehringer Mannheim Diagnostics Creatinine Reagent. No. 1050702. Both Creatinine test systems are used to measure creatinine concentrations in serum, plasma, or urine and the reaction principles are similar. In comparison studies against BMD using the manual procedure a correlation coefficient of 0.999 and a regression equation y = 1.11x + 0.05 was obtained with 128 serum samples. In comparison studies against BMD using the manual procedure a correlation coefficient of 0.998 and a regression equation y = 1.13x -0.17 was obtained with urine samples. With-in run precision and total precision on serum samples indicate acceptable values can be replicated on a day to day basis. Sigma Diagnostics Creatinine reagent has been determined to be linear to 25 mg/dL.
REFERENCES
- Tietz NW: Textbook of Clinical Chemistry. WB Saunders. Philadelphia, 1986, pp 1. 1271-1281.
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- Bowers LD, Wong ET: Kinetic serum creatinine assays. II. An initial evaluation and review. Clin Chem 26:255, 1980.
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- Jaffe M: Uber den Niederschlag, welchen Picrinsaure in normalen Harn erzeugt und uber eine neue Reaction des Kreatinins. Hoppe Seylers Z Physiol Chem 10:391, 1886.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
000 2 6 997
William R. Gilbert, Ph.D. . Manager, Scientific Affairs Sigma Diagnostics 545 South Ewinq Avenue St. Louis, MO 63103
Re: K972743 Sigma Diagnostics Creatinine Reaqent Requlatory Class: II Product Code: CGX Dated: July 18, 1997 Received: July 23, 1997
Dear Dr. Gilbert:
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, Druq, and Cosmetic Act (Act). You mav, 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. ਬੈ 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 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 regulations.
2
Paqe 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 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 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 Bitman
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
3
Page 1 __of__1 __
510(k) Number (if known):
Device Name: _Sigma Diagnostics Creatinine Reagent
Indications For Use:
Sigma Diagnostics Creatinine Reagent is intended to measure creatinine levels in serum, plasma, Sigma Diagos monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carol Benson for Alfred Montgomery
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K972743
Prescription Usej (Per 21 CFR 801.109)
Over-The-Counter Use