(408 days)
The Teco Diagnostics UTI Test Strips are intended for the qualitative detection of Nitrite and Leukocytes in urine as an aid in the screening of urinary tract infection (UTI). It is intended for over-the-counter home use only.
Teco Diagnostics UTI Test Strips provides tests for the qualitative determination of leukocytes and nitrite in urine. The product is a firm plastic strip to which is affixed two separate dry reagent pad areas that is used for urinalysis. The reagent pad areas are bibulous material saturated with chemically active substances. All UTI Test Strips are carefully packaged along with a desiccant in a sealed, foil pouch. The color chart for reading the strips is on the outside of the foil pouch. A package insert is packaged along with the foil pouch into a box. The package insert contains all the necessary product information. Results of each test are based on the color produced from the reaction of each reagent pad area once the Urine Reagent Strip comes into contact with a urine sample. Each parameter is color coded accordingly as described in the color chart. Results with Teco Diagnostics UTI Test Strips can be obtained in clinically meaningful units directly by comparison with the color chart. The color blocks represent nominal values will vary around the nominal values.
The Teco Diagnostics UTI Test Strips are intended for the qualitative detection of Nitrite and Leukocytes in urine as an aid in the screening of urinary tract infection (UTI). It is intended for over-the-counter home use only.
The device's performance was proven through a combination of laboratory and clinical studies demonstrating its substantial equivalence to the predicate device, Bayer Multistix 10 SG Reagent Strips for Urinalysis (K905396).
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The provided document does not explicitly state numerical acceptance criteria (e.g., specific sensitivity or specificity thresholds) or quantitative device performance metrics (e.g., exact percentages for accuracy, sensitivity, or specificity). Instead, the studies aim to demonstrate that the Teco Diagnostics UTI Test Strips "run well and met all required performance characteristics" and that lay users could "obtain comparable testing data compared to those obtained by the professionals" and to the predicate device.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Sensitivity | The device should accurately detect the presence of Nitrite and Leukocytes to aid in UTI screening. | Laboratory studies (sensitivity studies) indicate the device performs satisfactorily. |
| Reproducibility | Consistent results should be obtained when the test is repeated under the same conditions. | Laboratory studies (reproducibility study) indicate the device performs satisfactorily. |
| Interference | The device should not be significantly affected by interfering substances typically found in urine. | Laboratory studies (interference studies) indicate the device performs satisfactorily. |
| Stability | The device should maintain its performance over its shelf-life and under various storage conditions. | Laboratory studies (stress study and stability studies) indicate the device performs satisfactorily. |
| Clinical Accuracy | Lay users should be able to obtain clinically comparable and correct results when using the device compared to professional users and the predicate device. | Clinical study results indicated that inexperienced lay users were able to obtain comparable testing data compared to those obtained by professionals when using Teco Diagnostics UTI Test Strips and the Bayer Multistix 10 SG Reagent Strips for Urinalysis. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size for the clinical test set or the laboratory test set.
- Data Provenance: The clinical studies were conducted at "Point of Care sites" and "with lay persons," implying the data was collected from human urine samples. The document does not specify the country of origin, but given the submitter is based in Anaheim, CA, USA, and the predicate device is from Elkhart, IN, USA, it's highly probable the data is from the US. The studies are prospective in nature, as they involve testing the device on samples collected for the purpose of the study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document states that clinical studies compared results from "inexperienced lay users" to "professionals." It does not specify the exact number of professionals or their specific qualifications (e.g., "radiologist with 10 years of experience"). However, given the context of urinalysis, these professionals would likely be trained medical technicians, nurses, or other healthcare providers familiar with performing and interpreting urine reagent strip tests in a clinical setting.
4. Adjudication method for the test set
The document does not mention a specific adjudication method like "2+1" or "3+1." It implies a direct comparison, stating "inexperienced lay users were able to obtain comparable testing data compared to those obtained by the professionals." This suggests that the professionals' readings or a more definitive lab result for the same sample served as the benchmark against which lay users' readings were compared.
5. 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
- MRMC Study: A type of comparative effectiveness study was done comparing the performance of lay users and professionals using the Teco Diagnostics UTI Test Strips, and against the predicate device. This aligns with the spirit of an MRMC study in that it assesses different "readers" (lay vs. professional) on the same "cases" (urine samples).
- Effect Size/AI Assistance: This study does not involve AI assistance. The comparison is between human readers (lay vs. professional) and between two different manual test strips. Therefore, there is no effect size related to AI improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done. This device is a manual urine reagent strip, requiring human-in-the-loop performance (visual interpretation of color changes).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the clinical study was based on the results obtained by "professionals" using either the Teco Diagnostics UTI Test Strips or the legally marketed Bayer Multistix 10 SG Reagent Strips for Urinalysis. This can be considered a form of expert reference or standard device comparison, where the predicate device's results and professional interpretation of the test strips serve as the benchmark. It is not explicitly stated if further confirmatory tests (e.g., urine culture for UTI) were used as the ultimate ground truth, but the focus is on the performance of the test strips themselves in aiding screening.
8. The sample size for the training set
The document does not specify a separate "training set" or its sample size. For medical devices, particularly those without complex algorithms that "learn," the concept of a distinct training set (as in machine learning) may not directly apply in the same way. The development and optimization of the test strip's chemical reagents and color chart would be an iterative process, but not typically referred to as "training" in the context of sample sizes in regulatory submissions like this.
9. How the ground truth for the training set was established
As there's no explicitly defined "training set" in the machine learning sense, the concept of establishing ground truth for it is not applicable here. The development of the test strip's performance (e.g., sensitivity, reproducibility, stability) would have been established through internal laboratory studies where known concentrations of analytes and controlled conditions were used to assess and optimize the reagents' performance. This would involve established analytical methods as a form of reference.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows a black hexagon with the letters 'TC' in white inside. The letters are in a simple, sans-serif font and are stacked on top of each other. The hexagon is solid black, providing a strong contrast to the white letters. The overall design is simple and modern.
FEB 1 7 2011
510(k) SUMMARY
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 K100024
Submitter's Identification:
Teco Diagnostics, Inc. 1268 N. Lakeview Avenue Anaheim, CA 92807
Tel: 714-463-1111 Fax: 714-463-1169
Date Prepared: December 18, 2009
Contact Person:
Dr. KC Chen
Proprietary Name of the Device:
Teco Diagnostics UTI Test Strips
Common Name:
Urine Reagent Strips (URS)
Regulation Section and Classification:
21 CFR § 862.1510 Nitrite (Non-Quantitative) Test System Leukocyte Peroxidase Test 21 CFR § 864.7675
Class I: Urinary Leukocytes, Nitrite
Product Code:
Test, Urine Leukocyte LJX Nitrite (urinary, non-quantitative) test system JMT
Medical Specialty:
Clinical Chemistry
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows a logo with the letters 'TC' in white, set against a black hexagon. The letters are bold and sans-serif, with the 'T' slightly taller than the 'C'. The hexagon provides a solid, geometric background that makes the letters stand out.
Predicate Device:
Multistix 10 SG Reagent Strips for Urinalysis, K905396 Bayer Corporation, marketed by Bayer Corporation, located at Elkhart, IN 46515, USA.
Device Description:
Teco Diagnostics UTI Test Strips provides tests for the qualitative determination of leukocytes and nitrite in urine. The product is a firm plastic strip to which is affixed two separate dry reagent pad areas that is used for urinalysis. The reagent pad areas are bibulous material saturated with chemically active substances. All UTI Test Strips are carefully packaged along with a desiccant in a sealed, foil pouch. The color chart for reading the strips is on the outside of the foil pouch. A package insert is packaged along with the foil pouch into a box. The package insert contains all the necessary product information.
Results of each test are based on the color produced from the reaction of each reagent pad area once the Urine Reagent Strip comes into contact with a urine sample. Each parameter is color coded accordingly as described in the color chart. Results with Teco Diagnostics UTI Test Strips can be obtained in clinically meaningful units directly by comparison with the color chart. The color blocks represent nominal values will vary around the nominal values.
Intended Use:
The Teco Diagnostics UTI Test Strips are intended for the qualitative detection of Nitrite and Leukocytes in urine as an aid in the screening of urinary tract infection (UTI). It is intended for over-the-counter home use only.
Test Principles:
Nitrite: This test depends on the conversion of nitrite by the action of Gram-negative bacteria in the urine. The nitrite reacts with p-arsanilic acid to from a diazonium compound in an acid medium. The diazonium compound in turn couples with 1,2,3,4-tetrahydrobenzo(h) quinolin to produce a pink color.
Leukocyte: This test is based on the action of esterase present in leukocytes, which catalyzes the hydrolysis of an indoxyl ester derivative. The indoxyl ester liberated reacts with a diazonium salt to produce a beige-pink to purple color.
Substantial Equivalence:
The Teco Diagnostics UTI Test Strips for Leukocyte and Nitrite are substantially equivalent to the Bayer Multistix 10-SG Reagent Strips for Urinalysis (K905396).
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows a logo with the letters 'TC' in white, set against a black hexagon. The letters are bold and sans-serif, with the 'T' slightly overlapping the 'C'. The hexagon is oriented with one point facing downwards, creating a visually stable and recognizable mark. A thin black line is visible above the hexagon, possibly indicating the top edge of a document or page.
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.tecodiag.com
Comparison of Characteristics with Predicate:
| Teco Diagnostics UTI Test Strips | Bayer Multistix 10 SG ReagentStrips | |
|---|---|---|
| Intended Use | For the qualitative detection of Nitriteand Leukocyte in urine as an aid in thescreening of urinary tract infection (UTI) | For qualitative detection of Glucose,Bilirubin, Ketone, pH, Blood (Occult),Specific Gravity, Protein,Urobilinogen, Leukocyte and Nitrite inurine to assist in diagnosis in kidneyfunction, liver function, metabolicdisorders and urinary tract infection. |
| IntendedUsers | Lay persons, over-the-counter use | For professional use in point-of-careurine testing |
| Specimen | Human Urine | Same |
| MaterialsProvided | Plastic test strips affixed with reagentpads | Same |
| Storage | 15 - 30°C | Same |
| NitriteTest Time | 60 seconds | Same |
| LeukocyteTest Time | 2 minutes | Same |
| NitriteParameterMethodology | This test depends on the conversion ofnitrate to nitrite by the action of Gram-negative bacteria in the urine. Thenitrite reacts with p-arsanilic acid tofrom a diazonium compound in an acidmedium. The diazonium compound inturn couples with 1,2,3,4-tetrahydrobenzo(h) quinolin to producea pink color. | Same |
| LeukocyteParameterMethodology | This test is based on the action ofesterase present in leukocytes, whichcatalyzes the hydrolysis of an indoxylester derivative. The indoxyl esterliberated reacts with a diazonium salt toproduce a beige-pink to purple color. | Same |
The devices differ in their intended users. UTI Test Strips are intended for lay users over the counter, whereas Multistix 10 SG is intended for professional use in point-of-care clinical sites. The possible errors associated with lay user testing were investigated in a clinical, comparison study where both lay users and professional users tested the strips on the same sample. The study demonstrated that the strips were able to be read correctly and easily among lay users.
The predicate device, Multistix 10 SG, also tests eight other analytes, including Glucose, Bilirubin, Ketone, pH value, Blood (Occult), Specific Gravity, Protein and Urobilinogen, intended in the assisting the diagnosis in the areas of kidney function, liver function and metabolic disorders. However, these analytes are not used to aid in the diagnosis of urinary tract infection and the safety and effectiveness of Teco Diagnostics' UTI Test Strips are not affected by the drop of these test analytes.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows a logo with the letters "TC" in a bold, sans-serif font. The letters are stacked, with "T" above "C". The logo is contained within a black hexagon. The letters "TC" are white, creating a contrast with the black background of the hexagon.
Summary of Clinical Tests Performed:
The clinical studies were conducted at Point of Care sites and with lay persons using the Teco Diagnostics UTI Test Strips versus Multistix 10 SG. Clinical data were presented evaluating clinical accuracy of results. Clinical study results indicate that the inexperienced lay users were able to obtain comparable testing data compared to those obtained by the professionals when using the Teco Diagnostics UTI Test Strips and the legally marketed Bayer Multistix 10 SG Reagent Strips for Urinalysis (K905396).
Summary of Laboratory Tests Performed:
The Laboratory studies were conducted in house and included sensitivity studies, reproducibility study, interference studies, stress study, and stability studies. The obtained laboratory data indicate that Teco Diagnostics UTI Test Strips run well and met all required performance characteristics.
Conclusion:
The performance characteristics of the Teco Diagnostics UTI Test Strips were verified by sensitivity study, reproducibility study, interference studies, and temperature stress study. Testing results indicate that Teco Diagnostics UTI Test Strips can perform satisfactorily when used according to the "Test Procedure" directions on the package insert.
The laboratory testing results and clinical studies demonstrated a substantial equivalency on performance between the Teco Diagnostics UTI Test Strips and a legally marketed product, Bayer Multistix 10 SG Reagent Strips for Urinalysis (K905396), with similar product characteristics and intended use of aid in diagnosis in urinary tract infection.
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus-like symbol with three abstract shapes resembling birds or leaves. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Image /page/4/Picture/4 description: The image shows a date, which is February 17, 2011. The month is abbreviated as FEB. The day is 17, and the year is 2011. The date is written in a bold, sans-serif font.
TECO Diagnostics c/o Dr. KC Chen 1268 North Lakeview Avenue Anaheim, CA 92807
Re: K100024
Trade Name: TECO Diagnostics UTI Test Strips Regulation Number: 21 CFR 862.1510 Regulation Name: Nitrite (Non-Quantitative) Test System. Regulatory Class: Class I: (meets the limitations of exemptions in 21 CFR 862,9(c)(9) Product Codes: JMT, LJX Dated: January 12, 2011 Received: February 02, 2011
Dear Dr. Chen:
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
{5}------------------------------------------------
Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Viro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-fire no (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
C.C.
Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
Indications for Use
510(k) Number (If Known): K100024
Device Name: Teco Diagnostics UTI Test Strips
Indications for Use:
The Teco Diagnostics UTI Test Strips are intended for the qualitative detection of Nitrite and Leukocytes in urine as an aid in the screening of urinary tract infection (UTI). It is intended for over-the-counter home use only.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use__ > (21 CFR 801 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)
Director Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k/00024
Page 1 of 1
§ 862.1510 Nitrite (nonquantitative) test system.
(a)
Identification. A nitrite (nonquantitative) test system is a device intended to identify nitrite in urine. Nitrite identification is used in the diagnosis and treatment of uninary tract infection of bacterial origin.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.