(245 days)
Not Found
No
The summary describes a reagent kit for a standard enzymatic assay and does not mention any AI or ML components.
No
This device is an in-vitro diagnostic assay used for the quantitative determination of creatinine, which aids in the diagnosis and monitoring of renal diseases but does not actively treat or prevent them.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Creatinine measurements are used in the diagnosis and treatment of renal diseases." This indicates the device provides information for diagnostic purposes.
No
The device description clearly states it is a "reagent kit" for an in-vitro assay, which involves physical chemical components, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the L-Type Creatinine-M is an "in-vitro assay for the quantitative determination of creatinine in serum, plasma, and urine." The term "in-vitro" is a key indicator of an IVD, meaning it is used to test samples taken from the body, rather than being used directly on or in the body.
- Device Description: The description details a "reagent kit for creatinine assay based on the enzymatic method." Reagent kits used for analyzing biological samples are typical components of IVDs.
- Purpose: The intended use also mentions that 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 indicates the device is used for medical purposes related to diagnosis and monitoring, which is a core function of IVDs.
The information provided clearly aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
L-Type Creatinine M is an in vitro diagnostic assay for the quantitative determination of creatinine in serum, plasma or urine.
Creatinine measurement is one of the essential clinical tests in the diagnosis of uremia and renal diseases such as renal insufficiency and nephritis, and in monitoring renal diseases.
The L-Type Creatinine-M is an in-vitro assay 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.
Product codes (comma separated list FDA assigned to the subject device)
JFY, JIT
Device Description
Creatinine is an in vitro diagnostic assay for the quantitation of creatinine in serum, plasma or urine. Creatinine is produced directly from creatinine phosphate or by the dehydration of creatine in the muscles and nerves. The amount of metabolically produced creatinine in the urine is conveniently used to test glomerular function. Therefore, creatinine measurement is one of the essential clinical tests in the diagnosis of uremia and renal diseases such as renal insufficiency and nephritis, and in monitoring renal diseases. The enzymatic methods with high specificity are widely used to measure creatinine. L-Type Creatinine M is a reagent kit for creatinine assay based on the enzymatic method employing creatininase, creatinase, sarcosine oxidase and N-(3-sulfopropyl)-3-methoxy-5-methylaniline (HMMPS) as a new color agent.
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
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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)
A comparison of the L-Type Creatinine M and a similar Creatinine HA (modified Jaffé method) was performed using a Hitachi 917. The test results provided the following data: A correlation coefficient of 0.999, slope of 1.049 and a Y-intercept of -0.35 mg/dL for the serum application and a correlation coefficient of 0.998, slope of 1.038 and a Y-intercept of -0.94 for the urine application. A direct comparison between serum and plasma samples, both run on the Ltype Creatinine M method, yielded a correlation coefficient of 0.999, slope of 1.002 and a Y intercept of -0.04 for the serum/plasma application.
Precision studies were conducted using the L-Type Creatinine M assay on the Hitachi 917.
Within-run precision: n=21 using 3 levels of controls. The within-run % CV ranged from 0.42 to 2.38 for serum/plasma and from 0.41 to 0.68 for urine.
Total precision data was collected according to CLIS EP5-A1 guideline over a period of 21 days. The total % CV ranged from 0.40 to 1.59 for serum/plasma and from 0.37 to 0.50 for urine.
Measurement of creatinine in serum and plasma is linear in the range from 0.2 mg/dL to 100 mg/dL. Measurement of creatinine in urine is linear in the range from 1.0 mg/dL to 200 mg/dL. If the creatinine value exceeds the upper limit of measurable range, dilute the sample with saline, repeat the assay, and multiply the result by the dilution factor.
These data demonstrate that the performance of the L-Type Creatinine M assay is substantially equivalent to the Wako Creatinine HA assay on the Hitachi 917.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation coefficient of 0.999, slope of 1.049 and a Y-intercept of -0.35 mg/dL for serum application.
Correlation coefficient of 0.998, slope of 1.038 and a Y-intercept of -0.94 for urine application.
Correlation coefficient of 0.999, slope of 1.002 and a Y intercept of -0.04 for serum/plasma application.
Within-run % CV ranged from 0.42 to 2.38 for serum/plasma and from 0.41 to 0.68 for urine.
Total % CV ranged from 0.40 to 1.59 for serum/plasma and from 0.37 to 0.50 for urine.
Linearity:
Serum/Plasma 0.2-100 mg/dL
Urine 1.0-200 mg/dL
LLD:
Serum/Plasma= 0.03 mg/dL
Urine = 0.06 mg/dL
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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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Attachment 4
510(k) Summary
FEB 2 3 2007
| Submitter's Name/Address | Contact Person: |
|---|---|
| Wako Chemicals USA, Inc | Lori Creasy |
| Wako Diagnostics | Regulatory Affairs Specialist |
| 1600 Bellwood Road | 804-714-1932 |
| Richmond, Va. 23237 | Fax: 804-271-0449 |
| Date of Preparation of this Summary: | December 28, 2006 |
| Device Trade or Proprietary Name: | L-Type Creatinine M |
| Device Common/Usual Name or | |
| Classification Name: | Creatinine Test System |
| Classification Number/Class: | Class II 862.1225 |
| Product Code: | JFY |
| Predicate Device: | Creatinine HA |
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510(k) number is: K061775
Test Description:
Creatinine is an in vitro diagnostic assay for the quantitation of creatinine in serum, plasma or urine. Creatinine is produced directly from creatinine phosphate or by the dehydration of creatine in the muscles and nerves. The amount of metabolically produced creatinine in the urine is conveniently used to test glomerular function. Therefore, creatinine measurement is one of the essential clinical tests in the diagnosis of uremia and renal diseases such as renal insufficiency and nephritis, and in monitoring renal diseases. The enzymatic methods with high specificity are widely used to measure creatinine. L-Type Creatinine M is a reagent kit for creatinine assay based on the enzymatic method employing creatininase, creatinase, sarcosine oxidase and N-(3-sulfopropyl)-3-methoxy-5-methylaniline (HMMPS) as a new color agent.
Substantial Equivalence:
The L-Type Creatinine M is substantially equivalent to the Wako Creatinine HA 510(k) #K842847. Both assays yield similar Performance Characteristics.
1
Similarities:
- Both assays can be used for the quantitative of creatinine. .
- Both assays vield similar results. ●
Differences:
| Wako Creatinine HA
| 510 (k) # K842847 | Wako L-Type Creatinine M |
|---|---|
| Jaffé Method, rate assay | HMMPS-method, end point assay |
| Determination of Serum and urine | Determination of Serum, Plasma and |
| Urine. | |
| Linearity = 0-25 mg/dL | Linearity |
| Serum/Plasma 0.2-100 mg/dL | |
| Urine 1.0-200 mg/dL | |
| LLD = 0.0 mg/dL | LLD |
| Serum/Plasma= 0.03 mg/dL | |
| Urine = 0.06 mg/dL | |
| Calibrator= Creatinine Standard Solution | Calibrator = Creatinine Calibrator |
Intended Use:
L-Type Creatinine M is an in vitro diagnostic assay for the quantitative determination of creatinine in serum, plasma or urine.
Indications for use:
Creatinine measurement is one of the essential clinical tests in the diagnosis of uremia and renal diseases such as renal insufficiency and nephritis, and in monitoring renal diseases.
Performance Characteristics:
A comparison of the L-Type Creatinine M and a similar Creatinine HA (modified Jaffé method) was performed using a Hitachi 917. The test results provided the following data: A correlation coefficient of 0.999, slope of 1.049 and a Y-intercept of -0.35 mg/dL for the serum application and a correlation coefficient of 0.998, slope of 1.038 and a Y-intercept of -0.94 for the urine application. A direct comparison between serum and plasma samples, both run on the Ltype Creatinine M method, yielded a correlation coefficient of 0.999, slope of 1.002 and a Y intercept of -0.04 for the serum/plasma application.
Precision Studies
Precision studies were conducted using the L-Type Creatinine M assay on the Hitachi 917.
2
Within-run precision:
The within-run precision: n=21 using 3 levels of controls. The within-run % CV ranged from 0.42 to 2.38 for serum/plasma and from 0.41 to 0.68 for urine.
Total precision:
Total precision data was collected according to CLIS EP5-A1 guideline over a period of 21 days. The total % CV ranged from 0.40 to 1.59 for serum/plasma and from 0.37 to 0.50 for urine.
Measurement of creatinine in serum and plasma is linear in the range from 0.2 mg/dL to 100 mg/dL. Measurement of creatinine in urine is linear in the range from 1.0 mg/dL to 200 mg/dL. If the creatinine value exceeds the upper limit of measurable range, dilute the sample with saline, repeat the assay, and multiply the result by the dilution factor.
Conclusion:
These data demonstrate that the performance of the L-Type Creatinine M assay is substantially equivalent to the Wako Creatinine HA assay on the Hitachi 917.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (USA). The logo features a stylized eagle with three curved lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Lori Creasy Regulatory Affairs Specialist Wako Chemicals USA, Inc. Wako Diagnostics 1600 Bellwood Road Richmond, VA 23237
FEB 2 3 2007
K061775 Re: Trade/Device Name: L-Type Creatinine M Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine test system Regulatory Class: Class II Product Code: JFY, JIT Dated: January 09, 2007 Received: January 10, 2007
Dear Ms. Creasy:
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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Page 2 -
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.
Jean 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
5
Indications for Use
510(k) Number (if known): K061775
Device Name: L-Type Creatinine-M
Indications For Use:
The L-Type Creatinine-M is an in-vitro assay 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.
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 | Page 1 of |
| K061775 |