(133 days)
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No
The summary describes a standard in vitro diagnostic enzymatic assay for creatinine, with no mention of AI, ML, or related technologies. The performance studies focus on method comparison using linear regression, which is a statistical method, not AI/ML.
No
The device is described as an "IN VITRO diagnostic reagent system" for determining creatinine levels, which is used for diagnosis and monitoring, not for providing therapy.
Yes
This device is for the quantitative determination of creatinine in serum, plasma, and urine, and these measurements are used in the diagnosis and treatment of renal diseases, as stated in the "Intended Use / Indications for Use" section.
No
The device description explicitly states it is an "in vitro diagnostic reagent system" containing "two-part liquid in plastic bottles," indicating it is a chemical reagent kit, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "This device is intended for professional use and IN VITRO diagnostic use only."
- Device Description: The "Device Description" section also states: "The Enzymatic Creatinine Assay contains an in vitro diagnostic reagent system intended for the quantitative determination of creatinine in serum, plasma and urine."
- Purpose: The device is used to measure creatinine in biological samples (serum, plasma, and urine) to aid in the diagnosis and treatment of medical conditions (renal diseases). This is a core function of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For the IN VITRO quantitative determination of creatinine in serum, plasma and urine.
The Diagnostic Chemicals Limited Enzymatic Creatinine Assay is for the quantitative determination of creatinine 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. This device is intended for professional use and IN VITRO diagnostic use only.
Product codes
JFY
Device Description
The Enzymatic Creatinine Assay contains an in vitro diagnostic reagent system intended for the quantitative determination of creatinine 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. Reagent is a two-part liquid in plastic bottles packaged in the appropriate box.
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
professional use
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
Method comparison results provided the following:
Serum
Deming regression using NCCLS EP9-P.
A comparison was made between this method and a similar enzymatic method using 40 samples ranging from 0.7 to 31.2 mg/dL. The correlation coefficient was 1.0000. Linear regression analysis gave the following equation:
This method = 1.033 (reference method) - 0.13 mg/dL.
Urine
Deming regression using NCCLS EP9-P.
A comparison was made between this method and a similar enzymatic method using 40 samples ranging from 13.5 to 141.7 mg/dL. The correlation coefficient was 0.9995. Linear regression analysis gave the following equation:
This method = 1.041 (reference method) +1.06 mg/dL.
Plasma
Deming regression using NCCLS EP9-P.
A comparison was made between plasma and serum using 33 samples ranging from 0.61-27.04 mg/dL. The correlation coefficient was 0.9997. Linear regression analysis gave the following equation:
Plasma = 1.006 (serum) - 0.03 mg/dL.
Key Metrics
Correlation coefficient for Serum: 1.0000
Correlation coefficient for Urine: 0.9995
Correlation coefficient for Plasma: 0.9997
Predicate Device(s)
Reference Device(s)
Not Found
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.
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JUN 2 2 2007
Image /page/0/Picture/2 description: The image shows a logo or symbol that appears to be composed of stylized letters. The letters are bold and blocky, with a combination of straight lines and curves. The overall design is abstract and modern, with a focus on geometric shapes and negative space. The logo is likely used for branding or identification purposes.
Enzymatic Creatinine Assay
Product Cat. No. 265-30, 265-50
510(K) SUMMARY
Introduction:
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.
Submitter:
Diagnostic Chemicals Limited 16 McCarville Street Charlottetown, P.E.I. Canada C1E 2A6 (Tel:) (902)566-1396 (Fax:) (902)566-2498
Contact Person: Debbie Murray
Date Prepared: April 11, 2007
Device Name: Tradename: Enzymatic Creatinine Assay FDA Regulation Name: 862.1225 Creatinine Test System FDA Product Code: JFY
Predicate Device: Roche Diagnostics Corp. Creatinine Plus (K003261)
Device Description: The Enzymatic Creatinine Assay contains an in vitro diagnostic reagent system intended for the quantitative determination of creatinine 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. Reagent is a two-part liquid in plastic bottles packaged in the appropriate box.
Intended Use
For the IN VITRO quantitative determination of creatinine in serum, plasma and urine.
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Comparison to Predicate Device:
Description of the Item Being Compared:
Enzymatic in vitro assay for the direct quantitative determination of creatinine in human serum, plasma and urine using Roche automated clinical chemistry analyzers.
Creatinine Plus Reagent: R1 TAPS buffer: 30 mmol/L, pH 8.1; creatinase > 333 ukat/L; sarcosine oxidase > 133 ukat/L; ascorbate oxidase > 33 ukat/L; HTIB: 5.9 mmol/L; detergents; preservative.
Creatinine Plus Reagent: R2 TAPS buffer: 30 mmol/L, pH 8.0; creatininase > 500 µkat/L; peroxidase ≥ 16.7 µkat/L; 4-aminophenazone: 2.0 mmol/L; potassium hexacyanoferrate (II): 163 umol/L; detergent; preservative.
Similaries:
The submission device and the predicate device have the same intended use.
The submission device and the predicate device are both provided in a ready to use liquid format.
The submission device and the predicate device both use enzyme-linked steps using sarcosine oxidase and peroxidase to produce a colored product.
Differences:
There are no differences.
Comments on Substantial Equivalence:
Testing results demonstrate that the Enzymatic Creatinine Assay is equivalent to the predicate device. Method comparison results provided the following:
Serum
Deming regression using NCCLS EP9-P.
A comparison was made between this method and a similar enzymatic method using 40 samples ranging from 0.7 to 31.2 mg/dL. The correlation coefficient was 1.0000. Linear regression analysis gave the following equation:
This method = 1.033 (reference method) - 0.13 mg/dL.
2
Urine
Deming regression using NCCLS EP9-P.
A comparison was made between this method and a similar enzymatic method using 40 samples ranging from 13.5 to 141.7 mg/dL. The correlation coefficient was 0.9995. Linear regression analysis gave the following equation:
This method = 1.041 (reference method) +1.06 mg/dL.
Plasma
Deming regression using NCCLS EP9-P.
A comparison was made between plasma and serum using 33 samples ranging from 0.61-27.04 mg/dL. The correlation coefficient was 0.9997. Linear regression analysis gave the following equation:
Plasma = 1.006 (serum) - 0.03 mg/dL.
Conclusion:
Diagnostic Chemicals Limited's Enzymatic Creatinine Assay is substantially equivalent in principle and performance to the predicate product.
Debbie Murray, External Regulatory Affairs Coordinator Diagnostic Chemicals Limited Diagnostic Division
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 2 2007
Diagnostic Chemicals, Ltd. c/o Ms. Debbie Murray External Regulatory Affairs Coordinator 16 McCarville St. Charlottetown, Price Edward Island C1E 2A6 Canada
K070383 Re:
Trade Name: Enzymatic Creatinine Assay (265 series) Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine Test System Regulatory Class: Class II Product Code: JFY Dated: April 11, 2007 Received: May 04, 2007
Dear Ms. Murray:
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 (PMA). 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 (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, FDA 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 requirements of the Act 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 practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).
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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) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Yéan M. Cooper, M.S., D.V.M. 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:
16070383
Device Name:
Enzymatic Creatinine Assay (265 Series)
Indications For Use:
Reagent
The Diagnostic Chemicals Limited Enzymatic Creatinine Assay is for the quantitative determination of creatinine 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. This device is intended for professional use and IN VITRO diagnostic use only.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 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)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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