CREATININE LIQUICOLOR

K050283 · Stanbio Laboratory · JFY · Jun 30, 2005 · Clinical Chemistry

Device Facts

• Record ID: K050283
• Device Name: CREATININE LIQUICOLOR
• Applicant: Stanbio Laboratory
• Product Code: JFY · Clinical Chemistry
• Decision Date: Jun 30, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1225
• Device Class: Class 2

Intended 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.

Device Story

Stanbio Creatinine LiquiColor® is an in vitro diagnostic test system for professional use. It utilizes an enzymatic-colorimetric method to measure creatinine levels in serum and urine samples. The system consists of two reagents (R1 and R2) and a calibrator. The device requires a spectrophotometer capable of absorbance readings at 540nm. The healthcare provider uses the spectrophotometer to measure the colorimetric reaction; the resulting creatinine concentration is used to assist in the diagnosis and treatment of renal diseases, monitor renal dialysis, and serve as a calculation basis for other urine analytes. The device provides quantitative results to aid clinical decision-making regarding kidney function.

Clinical Evidence

Bench testing only. Performance evaluated via precision studies (intra-assay CV 0.41-1.14%; inter-assay CV 0.38-1.98%) and linearity studies (serum 0.04-5.1 mg/dL; urine 0.04-200 mg/dL). Method comparison performed on a Hitachi 717 analyzer using clinical and spiked samples (n=30 for serum, n=37 for urine) against the predicate device, yielding high correlation (r=0.9991 and r=0.9854 respectively). Analytical specificity confirmed for common interferents including bilirubin, hemoglobin, and ascorbic acid.

Technological Characteristics

Enzymatic-colorimetric assay. Requires spectrophotometer (540nm). Reagents stored at 2-8 °C. Linearity validated per NCCLS EP6-P2; precision validated per NCCLS EP5-A2. Standalone diagnostic test system.

Indications for Use

Indicated for the quantitative measurement of creatinine in serum or urine to assist in the diagnosis and treatment of renal diseases, monitoring of renal dialysis, and as a calculation basis for other urine analytes.

Regulatory Classification

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.

Predicate Devices

• Roche Diagnostics Creatinine Reagent (k941837)

Submission Summary (Full Text)

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Submitter's Name and Address:

Stanbio Laboratory 1261 North Main Street Boerne, Texas 78006

Phone: [phone] Fax: [phone]

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 | <div style="text-align:center;">Creatine amidinohydrolase</div> Sarcosine + Urea |
|---------------------------------------|----------------------------------------------------------------------------------|
| 3) Sarcosine + H2O + O2 | <div style="text-align:center;">Sarcosine oxidase</div> Glycine + HCHO + H2O2 |
| 4) 2H2O2 + 4-aminoantipyrine + *ESPMT | <div style="text-align:center;">Peroxidase</div> Quinoneimine Dye + 4 H2O |

*ESPMT: N-ethyl-N-sulfopropryl-m-toluidine

Roche Method

| Creatinine + Picric Acid | <div style="text-align:center;">alkaline</div> Red complex <div style="text-align:center;">pH</div> |
|--------------------------|-----------------------------------------------------------------------------------------------------|
|--------------------------|-----------------------------------------------------------------------------------------------------|

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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#### Page 2 -

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 [phone]. 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 [phone] or [phone] 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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