(143 days)
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No
The summary describes a chemical reagent-based test system for measuring creatinine levels, with no mention of AI, ML, image processing, or data training/testing sets typically associated with AI/ML devices.
No.
The device measures creatinine levels for diagnosis and monitoring, but it does not directly treat or provide therapy for renal diseases.
Yes
The "Intended Use / Indications for Use" states that creatinine measurements are "used in the diagnosis and treatment of renal diseases". This directly identifies the device's role in diagnosis.
No
The device description explicitly states it is comprised of two reagents and a calibrator, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is "intended to measure creatinine levels in serum or urine." Serum and urine are biological specimens taken in vitro (outside the body).
- Purpose: The 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 indicates a medical purpose for the results obtained from testing the in vitro samples.
- Device Description: The device is a "test kit comprised of two reagents." Reagents are used to perform chemical reactions on biological samples in vitro to obtain a measurement.
- Performance Studies: The performance studies describe testing performed on "Serum specimens" and "Urine specimens," further confirming the in vitro nature of the testing.
All these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in the in vitro examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The Stanbio Creatinine LiquiColor® test system is a device intended to measure creatinine levels in serum or 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.
Product codes
JFY
Device Description
The Creatinine LiquiColor® test kit is comprised of two reagents, Reagent 1 (R1) and Reagent 2. To calibrate the test kit, a calibrator is used that has values determined by a similar method.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial equivalency was demonstrated by method comparison to the Roche Diagnostics Creatinine reagent.
Correlation: Serum specimens (n = 30) were assayed by this method and by another commercial method.. Statistical analysis revealed a correlation coefficient (r) of 0.9991, w ith a regression equation of y = 1.4815x - 0.5831.
Correlation: Urine specimens (n = 37) were assayed by this method and by another commercial method. Statistical analysis revealed a correlation coefficient (r) of 0.9854, w ith a regression equation of y = 1.0545x + 0.3607.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision:
Intra Assay:
Mean (mg/dL): 0.610, SD: 0.007, CV%: 1.14
Mean (mg/dL): 1.107, SD: 0.009, CV%: 0.84
Mean (mg/dL): 5.733, SD: 0.02, CV%: 0.41
Inter Assay:
Mean (mg/dL): 0.629, SD: 0.008, CV%: 1.98
Mean (mg/dL): 1.134, SD: 0.011, CV%: 0.98
Mean (mg/dL): 5.814, SD: 0.022, CV%: 0.38
Sensitivity: Based on an instrument resolution of A = 0.001, the method presented shows a sensitivity of 0.04 mg/dL.
Linearity: When performed as directed, it is linear to 200 mg/dL.
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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Submitter's Name and Address:
Stanbio Laboratory 1261 North Main Street Boerne, Texas 78006
Phone: (830) 249-0772 Fax: (830) 249-0851
Prepared By: Kirk Johnson May 2, 2005
Product Name
| Trade Name: | Creatinine LiquiColor® |
|---|---|
| Common Name: | Creatinine Test |
| Classification Name: | Enzymatic Method, Creatinine |
| Classification: | II |
| Product Code: | JFY |
Substantial Equivalence of Device
This test is substantially equivalent to: Product Name: Creatinine Reagent 510(k) K941837 Roche Diagnostic
Description of Device
The Creatinine LiquiColor® test kit is comprised of two reagents, Reagent 1 (R1) and Reagent 2. To calibrate the test kit, a calibrator is used that has values determined by a similar method.
Intended Use of Device
The Stanbio Creatinine LiquiColor® test system is a device intended to measure creatinine levels in serum or 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.
Comparison of Devices
The Stanbio methods employ absorbance change as a means for quantitative determination of creatinine concentration in serum or urine. The Stanbio method employs an enzymatic test method described below, whereas, the Roche method uses a kinetic modification of the Jaffe reaction.
Stanbio Method
Creatinine amidohydorolase 1) Creatinine + H2O Creatine
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510(k) SUMMARY cont'd 510(k) K050283
| 2) Creatine + H2O | Creatine amidinohydrolase Sarcosine + Urea |
|---|---|
| 3) Sarcosine + H2O + O2 | Sarcosine oxidase Glycine + HCHO + H2O2 |
| 4) 2H2O2 + 4-aminoantipyrine + *ESPMT | Peroxidase Quinoneimine Dye + 4 H2O |
*ESPMT: N-ethyl-N-sulfopropryl-m-toluidine
Roche Method
| Creatinine + Picric Acid | alkaline Red complex pH |
|---|---|
| -------------------------- | ----------------------------------------------------------------------------------------------------- |
The rate of formation of the red colored complex is measured at 500 nm and is proportional to the creatinine concentration in the sample.
Performance Data Substantial equivalency was demonstrated by method comparison to the Roche Diagnostics Creatinine reagent.
Correlation
Correlation: Serum specimens (n = 30) were assayed by this method and by another commercial method.. Statistical analysis revealed a correlation coefficient (r) of 0.9991, w ith a regression equation of y = 1.4815x - 0.5831.
Correlation: Urine specimens (n = 37) were assayed by this method and by another commercial method. Statistical analysis revealed a correlation coefficient (r) of 0.9854, w ith a regression equation of y = 1.0545x + 0.3607.
Precision:
| Mean (mg/dL) | SD | CV% |
|---|---|---|
| In Series (Intra Assay) | ||
| 0.610 | 0.007 | 1.14 |
| 1.107 | 0.009 | 0.84 |
| 5.733 | 0.02 | 0.41 |
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510(k) SUMMARY cont'd 510(k) K050283
Day to Day (Inter Assay)
| 0.629 | 0.008 | 1.98 |
|---|---|---|
| 1.134 | 0.011 | 0.98 |
| 5.814 | 0.022 | 0.38 |
Sensitivity: Based on an instrument resolution of A = 0.001, the method presented shows a sensitivity of 0.04 mg/dL.
Linearity: When performed as directed, it is linear to 200 mg/dL.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The eagle is positioned to the right of a circular arrangement of text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
JUN 3 0 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Kirk Johnson QA/ Regulatory Affairs Manager Stanbio Laboratory 1261 North Main St. Boerne, TX 78006
Re: K050283
Trade/Device Name: Creatinine LiquiColor® Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine test system Regulatory Class: Class II Product Code: JFY Dated: May 2, 2005 Received: May 5, 2005
Dear Mr. Johnson:
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 (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) This icitel will anow you to begin manoung of substantial equivalence of your device to a legally premarker notification: "The sclassification 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, If you desire specific information advertising of your device, please contact the Office of In or questions on the prome 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 Tou may oount of Echerar michieanal 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,
Carol C. Benam
Carol C. Benson, M.A. Acting 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): K050283
Creatinine LiquiColor® Device Name:
Indications For Use:
The Stanbio Creatinine LiquiColor® test system is a device intended to THC Otanblo Oroutinine Erquis and urine. Creatinine measurements mcasure oroutinine loves and treatment of renal diseases, in monitoring are assuring the aloghes calculation basis for measuring other urine analytes.
Prescription Use (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
Division Sign-Off
Office of In Vitro Diagnos Device Evaluation and
510(k) K050283
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