(56 days)
A creatinine test system is a device intended to measure creatinine levels 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
Creatinine is an in vitro diagnostic assay for the quantitative analysis of creatinine in human serum, plasma, or urine. At an alkaline pH, creatinine in the sample 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 concentration of creatinine in the sample.
This submission describes the Abbott Laboratories Creatinine assay. This is an in vitro diagnostic assay used for the quantitative analysis of creatinine in human serum, plasma, or urine and is substantially equivalent to the Roche Creatinine assay (K941837) on the Hitachi 917 Analyzer.
1. Acceptance Criteria and Device Performance
| Parameter | Acceptance Criteria (Predicate Device K941837) | Device Performance (Abbott Creatinine Assay) |
|---|---|---|
| Correlation Coefficient (r) | Implied acceptable correlation (based on substantial equivalence claim) | Serum: 0.9996 (AEROSET), 0.9993 (ARCHITECT c8000) |
| Slope | Implied acceptable correlation (based on substantial equivalence claim) | Serum: 0.98 (AEROSET), 0.96 (ARCHITECT c8000) |
| Y-intercept | Implied acceptable correlation (based on substantial equivalence claim) | Serum: -0.19 mg/dL (AEROSET), -0.24 mg/dL (ARCHITECT c8000) |
| Urine Correlation Coefficient (r) | Implied acceptable correlation | Urine: 0.9992 (AEROSET), 0.9990 (ARCHITECT c8000) |
| Urine Slope | Implied acceptable correlation | Urine: 0.94 (AEROSET), 0.93 (ARCHITECT c8000) |
| Urine Y-intercept | Implied acceptable correlation | Urine: -3.66 mg/dL (AEROSET), -4.16 mg/dL (ARCHITECT c8000) |
| Precision (Total %CV - Serum) | Implied acceptable precision | Level 1: 4.95% (AEROSET), 3.10% (ARCHITECT c8000) |
| Level 2: 3.18% (AEROSET), 1.54% (ARCHITECT c8000) | ||
| Precision (Total %CV - Urine) | Implied acceptable precision | Level 1: 2.41% (AEROSET), 0.94% (ARCHITECT c8000) |
| Level 2: 2.41% (AEROSET), 0.99% (ARCHITECT c8000) | ||
| Linearity (Serum) | Implied acceptable linearity | 0.20 to 37.00 mg/dL |
| Linearity (Urine) | Implied acceptable linearity | 5.0 to 740.0 mg/dL |
| Limit of Quantitation (Sensitivity - Serum) | Implied acceptable sensitivity | 0.10 mg/dL |
| Limit of Quantitation (Sensitivity - Urine) | Implied acceptable sensitivity | 2.0 mg/dL |
Note: The acceptance criteria are "implied" as the document primarily focuses on demonstrating substantial equivalence to the predicate device (Roche Creatinine assay on Hitachi 917 Analyzer) by showing comparable performance characteristics rather than specifying explicit numeric thresholds for the Abbott device to meet independently.
2. Sample Size and Data Provenance (Test Set)
- Sample Size: Not explicitly stated for specific test sets in correlation or precision studies. The document refers to "comparative performance studies" and "precision studies." No specific number of patient samples or replicates is provided.
- Data Provenance: Not specified. It is likely that the data was generated internally by Abbott Laboratories during the development and validation of the assay, but the country of origin or whether it was retrospective or prospective is not mentioned.
3. Number and Qualifications of Experts for Ground Truth (Test Set)
Not applicable. This is an in vitro diagnostic assay for creatinine measurement, not an imaging device or a diagnostic algorithm requiring expert interpretation of complex data for ground truth establishment. The ground truth for this type of device is typically established by comparing its measurements to a legally marketed predicate device (as done here) or to a recognized reference method.
4. Adjudication Method (Test Set)
Not applicable. As described above, this is an in vitro diagnostic assay and does not involve human interpretation or adjudication processes for its test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is an in vitro diagnostic assay, not a device designed to assist human readers in interpreting medical images or other findings where an MRMC study would be relevant.
6. Standalone Performance Study
Yes, standalone performance studies were conducted to evaluate the Abbott Creatinine assay on the AEROSET and ARCHITECT c8000 Systems.
- Correlation Studies: Demonstrated the assay's performance against the predicate device (Roche Creatinine assay on Hitachi 917 Analyzer) by reporting correlation coefficients, slopes, and Y-intercepts.
- Precision Studies: Evaluated the reproducibility of the assay by reporting total %CV at different concentration levels.
- Linearity Studies: Established the range over which the assay provides accurate measurements.
- Limit of Quantitation (Sensitivity): Determined the lowest concentration that can be reliably measured.
These studies assess the algorithm's (or assay's) performance independently of human intervention.
7. Type of Ground Truth Used
The ground truth or reference standard for the comparative performance studies was the Roche Creatinine assay on the Hitachi 917 Analyzer (K941837), which is a legally marketed predicate device. For precision, linearity, and sensitivity, the ground truth would be expected values from reference materials or defined concentration levels.
8. Sample Size for the Training Set
Not applicable. This is an in vitro diagnostic assay based on a chemical reaction (modified Jaffe method), not a machine learning or AI-based device that requires a training set in the conventional sense. The "training" of such assays involves method development, optimization, and calibration using reference materials and quality controls.
9. How the Ground Truth for the Training Set was Established
Not applicable, as this device does not utilize a "training set" in the context of AI/machine learning. The assay's chemical principles and performance are established through laboratory experimentation, calibration using known standards, and validation studies.
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510(k) Summary
| Submitter's Name/Address | Contact Person |
|---|---|
| Abbott Laboratories | Linda Morris |
| 1921 Hurd Drive | Senior Regulatory Specialist, MS 2-11 |
| Irving, TX 75038 | Regulatory Affairs |
| (972) 518-6711 | |
| Fax (972) 518-7479 |
| Date of Preparation of this Summary: | April 26, 2006 |
|---|---|
| Device Trade or Proprietary Name: | Creatinine |
| Device Common/Usual Name orClassification Name: | Creatinine |
| Classification Number/Class: | Class II 862.1125 |
| Product Code: | CGX |
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: K 06 11 93
Test Description:
Creatinine is an in vitro diagnostic assay for the quantitative analysis of creatinine in human serum, plasma, or urine. At an alkaline pH, creatinine in the sample 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 concentration of creatinine in the sample.
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Substantial Equivalence:
The Creatinine assay is substantially equivalent to the Roche Creatinine assay (K941837) on the Hitachi 917 Analyzer. Both assays yield similar Performance Characteristics.
Similarities:
- . Both assays can be used for the quantitation of creatinine,
- . Both assays yield similar results.
- Both assays are based on the modified Jaffe (creatinine alkaline picrate) methodology. .
- Both assays use serum, plasma, and urine .
Differences:
None
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 Creatinine assay on the Hitachi 917 Analyzer. The AEROSET System showed a correlation coefficient of 0.9996, slope of 0.98, and Y-intercept of - 0.19 mg/dL for the serum application and a correlation coefficient of 0.9992, slope of 0.94, and Y-intercept of - 3.66 mg/dL for the urine application when compared to the Hitachi 917 Analyzer. The ARCHITECT c8000 System showed a correlation coefficient of 0.9993, slope of 0.96, and Y-intercept of - 0.24 mg/dL for the serum application and a correlation coefficient of 0.9990, slope of 0.93, and Y-intercept of - 4.16 mg/dL for the urine application when compared to the Hitachi 917 Analyzer. The ARCHITECT c8000 System showed a correlation coefficient of 0.9996, slope
Creatinine - Conc. 510(k) - R2 June 13, 2006
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of 0.98, and Y-intercept of - 0.06 mg/dL for the serum application and a correlation coefficient of 0.9997, slope of 0.99, and Y-intercept of - 0.51 mg/dL for the urine application when compared to the AEROSET System. The Creatinine assay method comparison vielded acceptable correlation between the AEROSET System and the ARCHITECT c8000 System.
Precision studies were conducted using the Creatinine assay. On the AEROSET System, the total %CV for Level 1 is 4.95%, and Level 2 is 3.18% for the serum application and the total %CV for Level 1 is 2.41%, and Level 2 is 2.41% for the urine application. On the ARCHITECT c8000 System, the total %CV for Level 1 is 3.10%, and Level 2 is 1.54% for the serum application and the total %CV for Level 1 is 0.94%, and Level 2 is 0.99% for the urine application.
The Creatinine assay is linear from 0.20 to 37.00 mg/dL for the serum application. The Creatinine assay is linear from 5.0 to 740.0 mg/dL for the urine application. The limit of quantitation (sensitivity) of the Creatinine assay is 0.10 mg/dL for the serum application, and 2.0 mg/dL for the urine application.
These data demonstrate that the performance of the Creatinine assay is substantially equivalent to the performance of the Creatinine assay on the Hitachi 917 Analyzer.
Conclusion:
The Creatinine assay on the AEROSET and the ARCHITECT c8000 Systems is substantially equivalent to the Roche Creatinine assay on the Hitachi 917 Analyzer as demonstrated by results obtained in the studies.
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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 3 2006
Ms. Linda Morris Sr. Regulatory Specialist ADD Regulatory Affairs Abbott Laboratories Inc. 1921 Hurd Drive Irving, TX 75038
Re: K061193
Trade/Device Name: Abbott Clinical Chemistry Creatinine Regulation Number: 21 CFR§862.1225 Regulation Name: Creatine test system Regulatory Class: Class II Product Code: CGX Dated: April 26, 2006 Received: April 28. 2006
Dear Ms. Morris:
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 (D114). 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 misbrandi, noand 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 EDA 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 maurements not hit . . cr 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 proctice requirements as set forth in the quality systems (QS) regulation (21 CFR Party 800).
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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) 276-0484. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto Gutt
Alberto Gutierrez, Ph.D. 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 (if known):
Device Name: Abbott Clinical Chemistry Creatinine
Indications For Use:
A creatinine test system is a device intended to measure creatinine levels 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
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 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)
G.C.
-nos of in Vitro Diagnostic 1 . duation and Safi
042 K001493
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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.