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 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Creatinine LiquiColor® device:

Acceptance Criteria and Device Performance

The provided document describes a 510(k) submission, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than setting new, explicit acceptance criteria for novel performance claims. However, the performance data presented implicitly sets the "acceptance criteria" by showing performance comparable to the predicate device and within generally accepted analytical limits for clinical assays.

Here's a table summarizing the reported performance, with the understanding that these values, by virtue of leading to substantial equivalence, implicitly served as the 'acceptance criteria' for this submission.

| Acceptance Criteria (Implicit) | Reported Device Performance |
|---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-|
| Method Comparison (Correlation with Predicate) | Serum: Correlation coefficient (r) ≥ ~0.99 (based on observed 0.9991) Regression slope (y) ≈ 1.0 (based on observed 1.4815x - 0.5831, acknowledging a notable slope difference, but still showing strong correlation). | Serum: r = 0.9991, regression equation: y = 1.4815x - 0.5831 |
| | Urine: Correlation coefficient (r) ≥ ~0.98 (based on observed 0.9854) Regression slope (y) ≈ 1.0 (based on observed 1.0545x + 0.3607, showing good agreement). | Urine: r = 0.9854, regression equation: y = 1.0545x + 0.3607 |
| Precision (Intra-assay CV%) | Low CV% (e.g., < 2%) across different concentrations. | Intra-Assay: 0.610 mg/dL: CV% = 1.14%; 1.107 mg/dL: CV% = 0.84%; 5.733 mg/dL: CV% = 0.41% |
| Precision (Inter-assay CV%) | Low CV% (e.g., < 2%) across different concentrations. | Inter-Assay: 0.629 mg/dL: CV% = 1.98%; 1.134 mg/dL: CV% = 0.98%; 5.814 mg/dL: CV% = 0.38% |
| Sensitivity | Low detection limit, clinically relevant (e.g., < 0.1 mg/dL for creatinine). | 0.04 mg/dL (based on instrument resolution A = 0.001) |
| Linearity | Wide linear range, covering clinically relevant creatinine concentrations (e.g., up to 200 mg/dL for severe renal impairment). | Linear to 200 mg/dL |

Note on "Acceptance Criteria": As this is a 510(k) summary, formal, explicit "acceptance criteria" (e.g., "The device must achieve an R-squared of X or greater compared to the predicate") are not typically stated in the summary itself. The demonstration of "Substantial Equivalence" inherently means that the device's performance, as measured by these studies, met the FDA's unwritten (or, in some cases, guidance-specified) expectations for equivalence to the predicate. The reported values are the results that led to this determination.

Study Details

The provided text describes analytical studies to demonstrate "substantial equivalence" of the Creatinine LiquiColor® test to a predicate device (Roche Diagnostics Creatinine reagent, 510(k) K941837).

Sample Sizes Used for the Test Set and Data Provenance:
- Serum: n = 30 specimens
- Urine: n = 37 specimens
- Data Provenance: Not explicitly stated (e.g., country of origin, demographics of sample donors). It is, however, implied to be a prospective collection of patient samples for comparison testing, as common in method comparison studies. It is not specified if these were "retrospective" (archived samples) or "prospective" (newly collected for the study).
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. This device is a quantitative clinical chemistry assay. The "ground truth" for the test set is established by the predicate device's measurement (Roche Diagnostics Creatinine reagent), not by expert opinion. The study aims to show correlation between the new device's measurements and the predicate's measurements. There is no mention of experts establishing a "ground truth" in terms of diagnosis or interpretation.
Adjudication Method:
- Not applicable. As described above, the study compares quantitative measurements from two different analytical methods. There is no diagnostic endpoint requiring adjudication by experts.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or interpretation tasks where multiple human readers assess cases. This device is a quantitative in vitro diagnostic assay.
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, the performance data presented (Correlation, Precision, Sensitivity, Linearity) represents the standalone performance of the Creatinine LiquiColor® enzymatic assay. There is no human interpretation component in the measurement or result generation for this type of IVD, so the "algorithm only" performance is the only performance. The device provides a quantitative creatinine value without human interpretation required for the numerical result itself.
Type of Ground Truth Used:
- Predicate Device Measurements: The "ground truth" in this context is the quantitative creatinine concentration determined by the predicate device (Roche Diagnostics Creatinine reagent). The study aims to demonstrate that the new device's results are in agreement with these "ground truth" values established by the already-approved predicate method.
Sample Size for the Training Set:
- Not applicable. This device is an enzymatic chemical assay, not a machine learning or AI algorithm in the contemporary sense that would require a "training set." The methodology is based on established biochemical reactions rather than learned patterns from data.
How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no "training set" for this type of device. The assay's mechanism is defined by the chemical reactions rather than statistical learning from data.

Summary

{0}------------------------------------------------

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

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

page 19

{1}------------------------------------------------

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

{2}------------------------------------------------

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.

{3}------------------------------------------------

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).

{4}------------------------------------------------

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 (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

{5}------------------------------------------------

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

Page 1 of _

. . . . . . .

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.