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.

Device Description

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the L-Type Creatinine M device, based on the provided text:

Acceptance Criteria and Device Performance

The core of the acceptance criteria for the L-Type Creatinine M device is its substantial equivalence to the predicate device, Wako Creatinine HA. This is demonstrated through similar performance characteristics, particularly in correlation, linearity, and precision.

Acceptance Criteria Category	Specific Criteria/Target Performance	Reported Device Performance (L-Type Creatinine M)
Correlation with Predicate	"Similar Performance Characteristics" (specifically comparing to Wako Creatinine HA)	Serum Application: Correlation coefficient of 0.999, slope of 1.049, Y-intercept of -0.35 mg/dL
		Urine Application: Correlation coefficient of 0.998, slope of 1.038, Y-intercept of -0.94
Linearity (Serum/Plasma)	Similar to predicate (predicate: 0-25 mg/dL)	0.2-100 mg/dL (Wider range than predicate)
Linearity (Urine)	Similar to predicate (predicate: 0-25 mg/dL)	1.0-200 mg/dL (Wider range than predicate)
Lower Limit of Detection (LLD)	Similar to predicate (predicate: 0.0 mg/dL)	Serum/Plasma: 0.03 mg/dL
		Urine: 0.06 mg/dL
Within-run Precision	Not explicitly stated as a numerical target, but "good precision" implied.	Serum/Plasma: %CV ranged from 0.42 to 2.38 (n=21, 3 levels of controls)
		Urine: %CV ranged from 0.41 to 0.68 (n=21, 3 levels of controls)
Total Precision	Not explicitly stated as a numerical target, but "good precision" implied.	Serum/Plasma: %CV ranged from 0.40 to 1.59 (over 21 days according to CLSI EP5-A1)
		Urine: %CV ranged from 0.37 to 0.50 (over 21 days according to CLSI EP5-A1)
Serum/Plasma Sample Comparison	"Similar results" when comparing serum and plasma samples run with the new method.	Correlation coefficient of 0.999, slope of 1.002, Y-intercept of -0.04

Study Details

Based on the provided text, the study focuses on analytical performance characteristics rather than clinical evaluation with human subjects.

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of individual patient samples. The correlation studies likely involved a range of samples to cover the linearity range. Precision studies used "3 levels of controls" with n=21 for within-run and data collected over 21 days for total precision.
- Data Provenance: Not specified (e.g., country of origin). The studies appear to be laboratory-based analytical performance evaluations, not involving retrospective or prospective human clinical data in the traditional sense.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is an in vitro diagnostic (IVD) assay where "ground truth" for analytical performance is established through reference methods and reference materials, not expert consensus on human images or clinical outcomes.
Adjudication method for the test set: Not applicable. As an IVD assay's analytical performance study, there's no adjudication process as would be found in image-based diagnostic or clinical trial settings.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is an IVD assay, not an AI-assisted diagnostic imaging device that involves human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Yes, the entire study describes the standalone analytical performance of the L-Type Creatinine M assay. It is an "algorithm only" in the sense that it's an automated chemical assay without human interpretation of results influencing its fundamental analytical performance.
The type of ground truth used:
- For the correlation studies comparing to the predicate (Creatinine HA), the "ground truth" is essentially the results obtained from the predicate device (Wako Creatinine HA), which is a legally marketed device with established performance.
- For linearity studies, the ground truth is established by preparing known concentrations of creatinine.
- For precision studies, the ground truth is the "true" or assigned value of the control materials used.
The sample size for the training set: Not applicable. This is not a machine learning or AI device that requires a training set. Its "training" involves the chemical formulation and optimization of the reagents.
How the ground truth for the training set was established: Not applicable, as there is no "training set" in the context of device development for this type of IVD, as mentioned above.

Summary

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Attachment 4

K061775

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 orClassification 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.

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Similarities:

Both assays can be used for the quantitative of creatinine. .
Both assays vield similar results. ●

Differences:

Wako Creatinine HA510 (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 andUrine.
Linearity = 0-25 mg/dL	LinearitySerum/Plasma 0.2-100 mg/dLUrine 1.0-200 mg/dL
LLD = 0.0 mg/dL	LLDSerum/Plasma= 0.03 mg/dLUrine = 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.

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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

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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

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Indications for Use

510(k) Number (if known): K061775

Device Name: L-Type Creatinine-M

Indications For Use:

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 DeviceEvaluation and Safety	Page 1 of
K061775

Regulation Number and Section

§ 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.