(127 days)
443340
Not Found
No
The document describes a standard chemistry assay for creatinine and does not mention any AI or ML components. The performance studies are based on traditional analytical methods like linearity and precision.
No
Explanation: This device is a quantitative test for creatinine that aids in the diagnosis and treatment of renal diseases, but it does not directly treat or prevent a disease.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that "Creatinine results are used in the diagnosis and treatment of renal dialysis and as a calculation basis for measuring other urine analytes." This indicates that the device provides information used for diagnosis.
No
The device description clearly states it is a "Reagent Kit" and a "Random Access Chemistry System," which are physical components used for chemical analysis, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states the device is for the "quantitative determination of creatinine in serum, plasma and urine." These are biological samples taken in vitro (outside the body).
- Purpose: The results are used "in the diagnosis and treatment of renal dialysis and as a calculation basis for measuring other urine analytes." This clearly indicates a diagnostic purpose.
- Device Description: The "Device Description" further reinforces this by stating it's for "quantitative determination of creatinine in serum, plasma and urine" and that the results are used "in the diagnosis and treatment of renal diseases, in monitoring renal dialysis and as a calculation basis for measuring other urine analytes."
- Method: The description of the method (reaction of creatinine with alkaline picrate and measuring absorbance) is a typical in vitro chemical analysis.
- Sample Types: The device analyzes serum, plasma, and urine, which are all biological specimens.
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 ATAC PAK Creatinine Reagent Kit is intended for the quantitative determination of creatinine in serum, plasma and urine. Creatinine results are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis and as a calculation basis for measuring other urine analytes.
The ATAC Creatinine Reagent Kit, the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitative determination of creatinine in serum, plasma and urine. Creatinine results are used in the diagnosis and treatment of renal dialysis and as a calculation basis for measuring other urine analytes.
This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.
Product codes
CGX, JIS
Device Description
The ATAC PAK Creatinine Reagent produces creatinine through the reaction of creatinine with alkaline picrate. The initial rate of absorbance increase at 510 nm is proportional to the creatinine concentration of the sample.
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
adult patients
Intended User / Care Setting
trained personnel in a professional setting
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 recovery of creatinine using the ATAC PAK Creatinine Reagent is linear from 0.2 to 25 mg/dL, as shown by the recovery of linearity standards that span the usable range. Regression statistics, which are forced through the origin, compare standard recoveries to standard values.
(ATAC Recoveries) = 0.997 x (Standard Value), Sy.x = 0.19 mg/dL, n = 27
Precision is demonstrated by the replicate assay of commercially available control serum. Precision statistics, calculated analogous to the methods described in NCCLS Guideline EP3-T, are shown below.
Precision of Creatinine Recoveries in mg/dL:
Sample: Serum 1, n: 120, mean: 0.7, Within Run 1SD: 0.05, Within Run %CV: 6.9%, Total 1SD: 0.05, Total %CV: 7.4%
Sample: Serum 2, n: 120, mean: 4.1, Within Run 1SD: 0.06, Within Run %CV: 1.6%, Total 1SD: 0.10, Total %CV: 2.5%
Sample: Serum 3, n: 120, mean: 7.2, Within Run 1SD: 0.18, Within Run %CV: 2.5%, Total 1SD: 0.24, Total %CV: 3.3%
Sample: Urine 1, n: 120, mean: 3.6, Within Run 1SD: 0.10, Within Run %CV: 2.8%, Total 1SD: 0.12, Total %CV: 3.3%
Sample: Urine 2, n: 120, mean: 14.8, Within Run 1SD: 0.42, Within Run %CV: 2.9%, Total 1SD: 0.60, Total %CV: 4.0%
Mixed serum, plasma and diluted urine specimens, collected from adult patients, were assayed for creatinine using the ATAC 8000 Random Access Chemistry System and another commercially available method. Results were compared by least squares linear regression and the following statistics were obtained.
Serum/Plasma Comparison ATAC 8000 = 0.07 mg/dL + 0.956 x Competitive Reagent r = 0.998 n = 200 range = 0.4 - 8.7 mg/dL
Urine Comparison ATAC 8000 = 0.02 mg/dL + 0.960 x Competitive Reagent r = 0.998 n = 96 range = 0.6 - 24.7 mg/dL
A specimen containing 1 mg/dL creatinine will produce an absorbance change of approximately 0.017 A on the ATAC 8000 Random Access Chemistry System.
The 24 hour calibration stability claim and the 7 day and reagent stability claims are documented through the assay of serum controls and urine pools over the claimed periods. In all cases, the total imprecision of creatinine recoveries over the test periods are less than 0.2 mg/dL or 5%.
Key Metrics
Not Found
Predicate Device(s)
Beckman Synchron CX Creatinine Reagent, product no. 443340
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.
0
FEB 1 4 2003
elan K023407
1075 W. Lambert Road Building D Brea, California 92821 T (714) 672 3553 F (714) 672 3554
Summary of 510(k) Safety and Effectiveness Information
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 ATAC PAK Creatinine Reagent Kit is intended for the quantitative determination of creatinine in serum, plasma and urine. Creatinine results are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis and as a calculation basis for measuring other urine analytes. The ATAC PAK Creatinines creatinine through the reaction of creatinine with alkaline picrate. The initial rate of absorbance increase at 510 nm is proportional to the creatinine concentration of the sample. The ATAC PAK Creatinine Reagent Kit is substantially equivalent to the Beckman Synchron CX Creatinine Reagent, product no. 443340, which is currently marketed by Beckman Coulter, Inc. of Brea California.
The effectiveness of ATAC PAK Creatinine Reagent Kit on the ATAC 8000 Random Access Chemistry System is shown by the following studies.
The recovery of creatinine using the ATAC PAK Creatinine Reagent is linear from 0.2 to 25 mg/dL, as shown by the recovery of linearity standards that span the usable range. Regression statistics, which are forced through the origin, compare standard recoveries to standard values. These statistics are shown below.
(ATAC Recoveries) = 0.997 x (Standard Value), Sy.x = 0.19 mg/dL, n = 27
Precision is demonstrated by the replicate assay of commercially available control serum. Precision statistics, calculated analogous to the methods described in NCCLS Guideline EP3-T, are shown below.
Precision of Creatinine Recoveries in mg/dL
| Sample | n | mean | Within Run | Total | ||
|---|---|---|---|---|---|---|
| 1SD | %CV | 1SD | %CV | |||
| Serum 1 | 120 | 0.7 | 0.05 | 6.9% | 0.05 | 7.4% |
| Serum 2 | 120 | 4.1 | 0.06 | 1.6% | 0.10 | 2.5% |
| Serum 3 | 120 | 7.2 | 0.18 | 2.5% | 0.24 | 3.3% |
| Urine 1 | 120 | 3.6 | 0.10 | 2.8% | 0.12 | 3.3% |
| Urine 2 | 120 | 14.8 | 0.42 | 2.9% | 0.60 | 4.0% |
Mixed serum, plasma and diluted urine specimens, collected from adult patients, were assayed for creatinine using the ATAC 8000 Random Access Chemistry System and another commercially available method. Results were compared by least squares linear regression and the following statistics were obtained.
Serum/Plasma Comparison ATAC 8000 = 0.07 mg/dL + 0.956 x Competitive Reagent r = 0.998 n = 200 range = 0.4 - 8.7 mg/dL Urine Comparison ATAC 8000 = 0.02 mg/dL + 0.960 x Competitive Reagent
r = 0.998 n = 96 range = 0.6 - 24.7 mg/dL A specimen containing 1 mg/dL creatinine will produce an absorbance change of approximately 0.017 A on the ATAC 8000
Random Access Chemistry System.
The 24 hour calibration stability claim and the 7 day and reagent stability claims are documented through the assay of serum controls and urine pools over the claimed periods. In all cases, the total imprecision of creatinine recoveries over the test periods are less than 0.2 mg/dL or 5%.
Wynn Stocking
Wynn Stocking
Wynn Stocking Manager of Regulatory Affairs Elan Diagnostics
510(k) Notification, ATAC PAK Creatinine Reagent Kit, 9 October, 2002, p 66
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines representing its body and wings. The eagle's head is facing left. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 1 4 2003
Mr. Wynn Stocking Regulatory Affairs Manager Elan Diagnostics 1075 W. Lambert Road Building D Brea. CA 92821
Re: K023407
Trade/Device Name: ATAC PAK Creatinine Reagent Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine test system Regulatory Class: Class II Product Code: CGX: JIS Dated: January 21, 2003 Received: January 21, 2003
Dear Mr. Stocking:
We have reviewed vour 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 vour 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 (QS) 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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
Device Name:
ATAC PAK Creatinine Reagent
Indications for Use:
The ATAC Creatinine Reagent Kit, the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitative determination of creatinine in serum, plasma and urine. Creatinine results are used in the diagnosis and treatment of renal dialysis and as a calculation basis for measuring other urine analytes.
This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.
Jian Cooges
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K023407
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) \
OR
Over-The-Counter Use __
(Optional Format 1-2-96)