(133 days)
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.
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.
The provided document is a 510(k) summary for a medical device called the "Enzymatic Creatinine Assay." This document describes the device and its comparison to a predicate device, focusing on substantial equivalence for regulatory purposes. It does not present acceptance criteria in a quantitative, pre-defined manner typical of performance goals for a new device. Instead, it demonstrates performance by comparing its results to a legally marketed predicate device (Roche Diagnostics Corp. Creatinine Plus) and showing a high correlation.
Therefore, for this specific submission, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device through strong correlation and linearity in method comparison studies.
Here's the information extracted and structured based on your request, with an emphasis on how the information is presented in the provided context:
Acceptance Criteria and Study Details for Enzymatic Creatinine Assay (K070383)
This 510(k) submission demonstrates the substantial equivalence of the Enzymatic Creatinine Assay to a predicate device, the Roche Diagnostics Corp. Creatinine Plus (K003261). The "acceptance criteria" are not explicitly stated as quantitative thresholds for performance metrics (e.g., sensitivity > 90%). Instead, the study aims to show a strong correlation and agreement with the predicate device, thereby demonstrating equivalent performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Strong linear correlation with predicate device for serum creatinine measurements. | Serum:Correlation Coefficient: 1.0000Linear Regression: This method = 1.033 (reference method) - 0.13 mg/dL (Range tested: 0.7 to 31.2 mg/dL) |
| Strong linear correlation with predicate device for urine creatinine measurements. | Urine:Correlation Coefficient: 0.9995Linear Regression: This method = 1.041 (reference method) + 1.06 mg/dL (Range tested: 13.5 to 141.7 mg/dL) |
| Strong linear correlation between plasma and serum creatinine measurements by the new method. | Plasma vs. Serum (using submission device):Correlation Coefficient: 0.9997Linear Regression: Plasma = 1.006 (serum) - 0.03 mg/dL(Range tested: 0.61-27.04 mg/dL) |
2. Sample Size Used for the Test Set and Data Provenance
- Serum: 40 samples
- Urine: 40 samples
- Plasma vs. Serum: 33 samples
- Data Provenance: Not explicitly stated regarding country of origin. The study describes "a comparison was made between this method and a similar enzymatic method," or "a comparison was made between plasma and serum." The context of a 510(k) from a Canadian company (Diagnostic Chemicals Limited) seeking FDA approval suggests the data would be relevant to North American populations, but this is not definitively stated. It is a retrospective method comparison study, using existing samples to compare two methods.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable/Not mentioned. This is a comparison of two diagnostic assays, where one (the predicate) serves as the reference or "ground truth" for evaluating the other. The "ground truth" is established by the existing, legally marketed predicate device's measured values, rather than by human expert interpretation of raw data.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods are typically used in studies where human readers interpret images or clinical data and their interpretations need to be reconciled by experts. In this analytical performance study comparing two quantitative assays, the comparison is directly between the numerical results generated by each assay. The statistical method used for comparison was Deming regression using NCCLS EP9-P.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study assesses the performance of human readers, with and without AI assistance, typically for image-based diagnostics. This submission is for an in vitro diagnostic (IVD) assay for chemical measurement, not an AI-powered diagnostic imaging device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes, a standalone performance study was done in the sense that the device's output (creatinine concentration) was directly compared to the predicate device's output. There is no human-in-the-loop component for the measurement of creatinine itself; the device automatically produces a quantitative result. The study evaluated the analytical performance of the new assay in isolation (i.e., its ability to accurately measure creatinine compared to a reference method).
7. Type of Ground Truth Used
- The "ground truth" in this context is the measurements obtained from the predicate device (Roche Diagnostics Corp. Creatinine Plus). The study aimed to demonstrate that the new Enzymatic Creatinine Assay produces results that are highly correlated and essentially interchangeable with those from the established predicate method.
8. Sample Size for the Training Set
- The document describes a method comparison study for showing substantial equivalence, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML. The samples mentioned above (40 serum, 40 urine, 33 plasma) comprise the samples used to test the performance of the new device relative to the predicate.
9. How the Ground Truth for the Training Set Was Established
- As there is no training set for an AI/ML model, this question is not applicable. For the performance evaluation, the "ground truth" was established by the measurements provided by the predicate device.
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JUN 2 2 2007
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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.
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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
K0703Y3
§ 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.