(414 days)
Not Found
No
The device is a reagent kit for in vitro diagnostic testing, and the summary describes standard analytical performance studies for a chemical assay. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is an in vitro diagnostic test for measuring creatinine levels, which provides information for diagnosis but does not directly treat or alleviate a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for measurement of creatinine level in human serum" and that "Test results may provide information regarding the status of kidney function and the diagnosis of renal diseases". This directly indicates its role in aiding diagnosis.
No
The device is a reagent kit, which is a chemical product used in laboratory tests. It is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "Creatinine Enzymatic Reagent Kit is a device which is intended for measurement of creatinine level in human serum, in vitro diagnostic use only."
This statement clearly indicates that the device is intended for use outside of the body to examine specimens (human serum in this case) for diagnostic purposes.
N/A
Intended Use / Indications for Use
Creatinine Enzymatic Reagent Kit is a device which is intended for measurement of creatinine level in human serum, in vitro diagnostic use only. Test results may provide information regarding the status of kidney function and the diagnosis of renal diseases, and also serve as a component of several calculations for determination of creatinine clearance or glomerular filtration rate (GFR).
Product codes (comma separated list FDA assigned to the subject device)
JFY
Device Description
Creatinine Enzymatic Reagent Kit is a dual reagent one contains Good's buffer, creatine amidinohydrolase, sarcosine oxidase and ESPMT (3-(N-Ethyl-3methylanilino) propanesulfonic acid sodium salt). Reagent two contains Good's buffer, creatinine amidohydrolase, Peroxidase and 4-aminoantipyrine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
This is an in vitro diagnostic test for prescription use only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision/Reproducibility:
Precision studies were performed based on upon the guidelines set forth in CLSI EP5-A. Intra-assay Precision was performed by assaying three serum pools at three concentrations over 20 operating days, on a single instrument at a single site and with two lots of reagents. Assay runs were performed twice per day and each sample was tested in triplicates.
Linearity/assay reportable range:
Linearity studies were performed based on upon the guidelines set forth in CLSI EP6-A. Linearity was performed by preparing samples from patient serum pools at a low creatinine concentration and a high concentration. Eleven samples in all were assayed in duplicates for each reagent lot. The expected values were plotted against the observed values and a linear regression line from one of the reagent lots fitted with the following regression equation: y = 0.9992x + 0.0007, R2 = 0.9983. The claimed measuring range for Teco Creatinine Enzymatic Reagent Kit is 0.37- 5.06 mg/dL.
Detection limit:
Limit Of Blank (LoB): The study was determined following CLSI EP17-A2 as a guideline. Four diluted real pooled serum samples were tested in the limit of blank study. Fifteen replicates of each sample were assayed using TC-MATRIX instrument and two reagent lots, with the total number of measurements being 60 for each lot. LoB: 0.00 mg/dL.
Limit Of Detection (LoD): The LoD study was determined following CLSI EP17-A2 as a guideline. In the Limit Of Detection the serum was determined by using two reagent lots. Four diluted serum samples of 100 times, 50 times, 33 times and 25 times were assayed 15 times for each sample (N = 60) on the TC-MATRIX instrument. LoD: 0.01 mg/dL.
Limit Of Quantitation (LoQ): The LoQ study was determined following CLSI EP17-A2 as a guideline. For LoQ determination, four low concentration samples were prepared by native serum sample pools and assayed fifteen times each (N = 60). LoQ: 0.10 mg/dL.
Analytical specificity:
Testing for interfering substances was based on CLSI EP7-A2. Testing was performed with two different clinically relevant concentrations of creatinine (1.50 and 5.00 mg/dL). Samples with increasing amounts of potential interferents were tested in triplicate and compared to a control sample without the interferent.
Comparison studies - Method comparison:
The performance of the Creatinine Enzymatic Reagent Kit was compared with the Stanbio Creatinine LiquiColor test system on TC-MATRIX analyzer. Study performed according to CLSI EP9-A3 using 98 serum samples covering the measuring range with values from predicate and the result from the linearity study in M 1.b. The linear regression is summarized as y=1.004x+0.0379, R2=0.9986. The labeling claims a measuring range of 0.37 to 5.06 mg/dL.
Expected values/Reference interval:
The reference interval for Creatinine was verified using CLSI guideline EP28-A3 by conducting a small study using human serum samples from 20 healthy male donors and 20 healthy female donors, from 20 to 65 years old. The samples were assayed on TC-MATRIX analyzer. All results from the total 40 healthy donors were found to be within the reported reference range.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus or a staff with a serpent entwined around it, but in this case, it is a more abstract, flowing design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 21, 2017
TECO DIAGNOSTICS, INC. XIAOYAN HU RESEARCHER 1268 NORTH LAKEVIEW AVENUE ANAHEIM CA 92807
Re: K161527
Trade/Device Name: Teco Creatinine Enzymatic Reagent Kit Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine test system Regulatory Class: II Product Code: JFY Dated: July 13, 2017 Received: July 14, 2017
Dear Xiaoyan Hu:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kellie B. Kelm -S
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161527
Device Name Teco Creatinine Enzymatic Reagent Kit
Indications for Use (Describe)
Creatinine Enzymatic Reagent Kit is a device which is intended for measurement of creatinine level in human serum, in vitro diagnostic use only. Test results may provide information regarding the status of kidney function and the diagnosis of renal diseases, and also serve as a component of several calculations for determination of creatinine clearance or glomerular filtration rate (GFR).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image shows a green hexagon with the letters "TC" in white. The letters are in a sans-serif font and are slightly offset from each other. The hexagon is a solid green color and has a slight gradient effect, making it appear slightly darker at the bottom. The image is simple and clean, with a focus on the logo itself.
This Summary of 510(k) Safety and Effectiveness is being submitted in accordance with the requirements of 21 CFR § 807.92.
Owner's Name: Teco Diagnostics, Inc.
Address and Contact information:
1268 North Lakeview Avenue Anaheim, CA 92807 Phone: 714-463-1111 Fax: 714-463-1169
Contact:
Xiaoyan Hu
Date Prepared:
July 20, 2017
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Image /page/4/Picture/1 description: The image features a green hexagon with the letters 'TC' in silver. The letters are stylized with a slight 3D effect, giving them a rounded appearance. The green background is a solid color, and the hexagon shape is well-defined. The overall design is simple and modern.
1268 N. Lakeview Ave., Anaheim, CA 92807, U.S.A. Phone: (714) 463-1111 Toll Free: 1-800-222-9880 Fax: (714) 463-1169 www.tecodiagnostics.com
510(k) SUMMARY
A. 510(k) Number:
-
K161527 B. Analytes:
Creatinine -
C. Type of Test: Enzymatic, quantitative
-
D. Applicant: Teco Diagnostics. Inc. E. Trade Name:
Teco Creatinine Enzymatic Reagent Kit
-
F. Common Name: Enzymatic Method, Creatinine
G. Regulatory Information: -
- Regulation Classification section: Class II: 21 CFR § 862.1225-Creatinine test system
-
- Product Code: JFY
-
- Panel:
75, Clinical Chemistry
H. Intended Use:
-
- Indication(s) for use:
Creatinine Enzymatic Reagent Kit is a device which is intended for measurement of creatinine level in human serum, in vitro diagnostic use only. Test results may provide information regarding the status of kidney function and the diagnosis of renal diseases, and also serve as a component of several calculations for determination or estimation of creatinine clearance or glomerular filtration rate (GFR).
- Indication(s) for use:
-
- Special conditions for use statement(s):
This is an in vitro diagnostic test for prescription use only.
- Special conditions for use statement(s):
-
- Special instrument requirements: TC-MATRIX analyzer
I. Device Description
Creatinine Enzymatic Reagent Kit is a dual reagent one contains Good's buffer, creatine amidinohydrolase, sarcosine oxidase and ESPMT (3-(N-Ethyl-3methylanilino) propanesulfonic acid sodium salt). Reagent two contains Good's buffer, creatinine amidohydrolase, Peroxidase and 4-aminoantipyrine.
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Image /page/5/Picture/1 description: The image shows a green hexagon with the letters "TC" in silver. The letters are stacked on top of each other, with the "T" on top and the "C" on the bottom. The hexagon has a slight gradient, with the top being slightly lighter than the bottom. The overall impression is that of a logo or icon.
J. Substantial Equivalence Information:
-
- Predicate device name(s): Stanbio Creatinine LiquiColor test system
-
- Predicate K number(s): K050283
-
- Compare with predicate:
Table 5.1 Creatinine Enzymatic Reagent Kit vs Stanbio Creatinine LiquiColor test system
| | Teco Creatinine Enzymatic
Reagent Kit | Stanbio Creatinine
LiquiColor test system |
|---------------------------------|------------------------------------------------------|------------------------------------------------------|
| Intended Use | For the quantitative determination
of creatinine. | Same |
| Intended Specimen | Serum | Serum and urine |
| Test Methodology | Enzymatic | Same |
| Linearity | Serum: 0.37- 5.06 mg/dL | Serum: 0.04 to 5.1 mg/dL
Urine: 0.04 to 200 mg/dL |
| Wavelength | Primary: 546 nm
Secondary: 670 nm | 546 nm |
| Accuracy/Correlation
(Serum) | y = 1.004x+ 0.0379
R2 = 0.9986 | y = 0.9993x+0.0018
R = 0.9999 |
| Storage | 2- 8 °C | Same |
K. Guideline Document Referred (if applicable):
-
CLSI EP5-A3, Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline Third Edition.
-
CLSI EP6-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach: Approved Guideline.
-
CLSI EP7-A2, Interference Testing in Clinical Chemistry; Approved Guideline Second edition.
-
CLSI EP9-A3, Method Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline Third edition.
-
CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures: Approve Guideline Second Edition.
-
CLSI EP25-A, Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline.
-
CLSI EP28-A3C, Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory: Approved Guideline Third Edition.
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Image /page/6/Picture/1 description: The image shows a green hexagon with the letters "TC" in white. The letters are in a sans-serif font and are slightly offset from each other. The hexagon has a subtle gradient, with the top being slightly lighter than the bottom. The overall impression is clean and modern.
1268 N. Lakeview Ave., Anaheim, CA 92807, U.S.A. Phone: (714) 463-1111 Toll Free: 1-800-222-9880 Fax: (714) 463-1169 www.tecodiagnostics.com
510(k) SUMMARY
L. Test Principle:
Creatinase in Reagent 1 hydrolyzes existing creatine in a sample to sarcosine and urea. Sarcosine is oxidized by sarcosine oxidase to glycine and formaldehyde and hydrogen peroxide. This hydrogen peroxide is reduced to water soon. Ceatininase in Reagent 2 hydrolyzes creatinine in sample to creatine. By the same reaction steps above, the hydrogen peroxide from creatinine reacts with 4-aminoantipyrine and ESPMT in the presence of peroxidase to yield a quinoneimine dye. The change in absorbance at 546 nm is proportional to the creatinine concentration in sample.
M. Performance Characteristics:
1. Analytical performance:
- a. Precision/Reproducibility:
Precision studies were performed based on upon the guidelines set forth in CLSI EP5-A. Intra-assay Precision was performed by assaying three serum pools at three concentrations over 20 operating days, on a single instrument at a single site and with two lots of reagents. Assay runs were performed twice per day and each sample was tested in triplicates. Results of the precision studies were summarized below:
| Sample Description | Mean (mg/dL) | Repeatability | Within-Laboratory Precision | ||
|---|---|---|---|---|---|
| SD | CV% | SD | CV% | ||
| Patient Pool 1 | 0.89 | 0.008353 | 0.93 | 0.01761 | 1.98 |
| Patient Pool 2 | 1.52 | 0.01323 | 0.87 | 0.03316 | 2.18 |
| Patient Pool 3 | 3.09 | 0.02800 | 0.90 | 0.03361 | 1.08 |
I OT· 080201
LOT: 080202
| Sample
Description | Mean
(mg/dL) | Repeatability | | Within- Laboratory
Precision | |
|-----------------------|-----------------|---------------|------|---------------------------------|------|
| | | SD | CV% | SD | CV% |
| Patient Pool 1 | 0.88 | 0.00922 | 1.05 | 0.02009 | 2.28 |
| Patient Pool 2 | 1.51 | 0.01039 | 0.69 | 0.03402 | 2.25 |
| Patient Pool 3 | 3.04 | 0.02736 | 0.90 | 0.03682 | 1.21 |
b. Linearity/assav reportable range:
Linearity studies were performed based on upon the guidelines set forth in CLSI EP6-A. Linearity was performed by preparing samples from patient serum pools at a low creatinine concentration and a high concentration. Eleven samples in all were assayed in duplicates for each reagent lot. The expected values were plotted against
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Image /page/7/Picture/1 description: The image is a logo with a green hexagon as the background. Inside the hexagon are the letters 'TC' in white. The letters are slightly shadowed, giving them a three-dimensional appearance. The logo is simple and clean, with a focus on the letters 'TC' against the green background.
the observed values and a linear regression line from one of the reagent lots fitted with the following regression equation:
| Expected Value
(mg/dL) | Observed Value
(mg/dL) |
|---------------------------|---------------------------|
| 0.37 | 0.374 |
| 0.94 | 0.946 |
| 1.50 | 1.518 |
| 2.06 | 2.090 |
| 2.71 | 2.663 |
| 3.31 | 3.235 |
| 3.83 | 3.807 |
| 4.38 | 4.379 |
| 4.90 | 4.951 |
| 5.49 | 5.523 |
| 6.12 | 6.095 |
Considering these testing concentrations from Linearity study and Method Comparison study, and the assay range of predicate device (0.04 - 5.1 mg/dL), the claimed measuring range for Teco Creatinine Enzymatic Reagent Kit is 0.37- 5.06 mg/dL. The regression is y = 0.9992x + 0.0007, R2 = 0.9983.
- c. Traceability, Stability, Expected values:
The stability claim was verified using an accelerated stability protocol. Real-time testing was conducted. The study results are summarized below:
| Storage Conditions | Claimed stability | |
|---|---|---|
| Closed-vial | $37 \pm 2$ °C | 20 days |
| Open-vial | 2 - 8°C, 20-30% humidity | 60 days |
| Real-time, closed-vial | 2 - 8°C, 20-30% humidity | Pending |
Traceability
The Teco chemistry calibrator values were obtained by multi determinations performed by Teco Diagnostics. The assigned value is the median of all values obtained. The assigned value of the calibrator is traceable to NIST reference material (SRM 967).
- d. Detection limit:
Limit Of Blank (LoB):
The study was determined following CLSI EP17-A2 as a guideline. Four diluted real pooled serum samples were tested in the limit of blank study. Fifteen replicates
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Image /page/8/Picture/1 description: The image shows a green hexagon with the letters "TC" in silver. The letters are stacked on top of each other, with the "T" on top and the "C" on the bottom. The letters are in a sans-serif font and have a slight shadow effect. The hexagon is a solid green color and has a slight gradient effect.
of each sample were assayed using TC-MATRIX instrument and two reagent lots, with the total number of measurements being 60 for each lot.
Based upon the studies conducted for LoB, the data were assessed using the nonparametric data analysis option, and the following results were obtained: 0.00 mg/dL.
Limit Of Detection (LoD):
The LoD study was determined following CLSI EP17-A2 as a guideline. In the Limit Of Detection the serum was determined by using two reagent lots. Four diluted serum samples of 100 times, 50 times, 33 times and 25 times were assayed 15 times for each sample (N = 60) on the TC-MATRIX instrument. Based upon the studies conducted for LoD and the reported LoB determined above, this gave result of 0.01 mg/dL.
Limit Of Quantitation (LoQ):
The LoQ study was determined following CLSI EP17-A2 as a guideline. For LoQ determination, four low concentration samples were prepared by native serum sample pools and assayed fifteen times each (N = 60). The CV% and the SD at each tested concentration were calculated. The LoQ accuracy goal is within 20% CV.
Results of Summary:
| LoB | LoD | LoQ | |
|---|---|---|---|
| Value (mg/dL) | 0.00 | 0.01 | 0.10 |
e. Analytical specificity:
Testing for interfering substances was based on CLSI EP7-A2. Testing was performed with two different clinically relevant concentrations of creatinine (1.50 and 5.00 mg/dL). Samples with increasing amounts of potential interferents were tested in triplicate and compared to a control sample without the interferent. The concentrations of substances that demonstrated no significant interference (≤10%) are listed below:
| Interference
Substance | Highest
concentration tested
with no significant
interference (≤10%) |
|---------------------------|-------------------------------------------------------------------------------|
| Unconjugated Bilirubin | 20 mg/dL |
| Conjugated Bilirubin | 16.7 mg/dL |
| Hemoglobin | 500 mg/dL |
| Triglycerides | 2500 mg/dL |
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Image /page/9/Picture/1 description: The image shows a green hexagon with the letters "TC" in white. The letters are stacked on top of each other, with "T" on top and "C" on the bottom. The hexagon has a gradient effect, with the top being slightly lighter than the bottom. The letters also have a slight shadow effect, making them appear to be raised from the surface of the hexagon.
1268 N. Lakeview Ave., Anaheim, CA 92807, U.S.A. Phone: (714) 463-1111 Toll Free: 1-800-222-9880 Fax: (714) 463-1169 www.tecodiagnostics.com
510(k) SUMMARY
| Ascorbic Acid | 20 mg/dL |
|---|---|
| Creatine | 6.0 mg/dL |
| Glucose | 1000 mg/dL |
| Acetaminophen | 20 mg/dL |
| Nitrofurantoin | 400 ug/dL |
| Uric acid | 25 mg/dL |
| Dopamine | 90.0 ug/dL |
| Methyldopa | 0.10 mg/dL |
| L- Dopa | 0.06 mg/dL |
| Calcium dobesilate | 1 mg/dL |
The following table shows the substances which did interfere with Teco Creatinine Enzymatic Reagent Kit. The concentrations of interfering substance that demonstrated a significant interference are listed below:
| Interference Substance | Concentration of
Substance at which
Interference was
observed |
|------------------------|------------------------------------------------------------------------|
| Conjugated Bilirubin | 24.95 mg/dL |
| Triglycerides | 3000 mg/dL |
| Creatine | 8.0 mg/dL |
| Methyldopa | 0.45 mg/dL |
| L- Dopa | 0.11 mg/dL |
| Calcium dobesilate | 3 mg/dL |
A summary of the interferents with effects is found in the labeling.
2. Comparison studies:
Method comparison
The performance of the Creatinine Enzymatic Reagent Kit was compared with the Stanbio Creatinine LiquiColor test system on TC-MATRIX analyzer. Study performed according to CLSI EP9-A3 using 98 serum samples covering the measuring range with values from predicate and the result from the linearity study in M 1.b. The linear regression is summarized as y=1.004x+0.0379, R2=0.9986.
Based on the detection limits determined in this study, the result from the method comparison study in M 2.a. and the result from the linearity study in M 1.b., the labeling claims a measuring range of 0.37 to 5.06 mg/dL.
3. Expected values/Reference interval:
The expected reference interval is derived from: Larsen K. Clin Chem Acta 41:209, 1972. The reference interval for Creatinine was verified using CLSI guideline EP28-
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Image /page/10/Picture/1 description: The image shows a green hexagon with the letters "TC" in white. The letters are in a sans-serif font and are slightly offset from the center of the hexagon. The hexagon has a subtle gradient, with the top being slightly lighter than the bottom. The overall impression is that of a logo or icon.
A3 by conducting a small study using human serum samples from 20 healthy male donors and 20 healthy female donors, from 20 to 65 years old. The samples were assayed on TC-MATRIX analyzer. All results from the total 40 healthy donors were found to be within the reported reference range. The Reference Interval for the study for Teco Creatinine Enzymatic Reagent Kit shows:
| Men | Women | |
|---|---|---|
| Serum (mg/dL) | 0.9 - 1.5 | 0.7 - 1.4 |
N. Conclusion:
The performance characteristics of Teco Creatinine Enzymatic Reagent Kit were verified by comparison, precision, linearity, detection limit, specificity and interference, shelf life, and stress studies. Testing results indicate that Teco Creatinine Enzymatic Reagent Kit performs satisfactorily when used appropriately, as outlined in the package insert. The result of performance studies demonstrates a substantial equivalency on performance between Teco Creatinine Enzymatic Reagent Kit and the predicate device, Stanbio Creatinine LiquiColor test system.