(119 days)
Not Found
No
The device description and performance studies indicate a simple visual color change test, with no mention of AI/ML or image processing.
No
This device is an in vitro diagnostic test for screening UTIs, not a therapeutic device. It is used to detect biomarkers (leukocytes and nitrite) in urine and does not provide any treatment or therapy.
Yes
This device is described as an "in vitro diagnostic test device" and is intended for the qualitative detection of specific indicators (leukocytes and nitrite) in urine to aid in the screening of a Urinary Tract Infection (UTI).
No
The device is described as an in vitro diagnostic test device composed of physical color pads on a strip for visual reading, indicating it is a hardware-based test, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is "for the qualitative detection of Leukocytes (LEU,white blood cells) and nitrite (NIT) in urine as an aid in the screening of a Urinary Tract infection (UTI)." This involves testing a sample taken from the human body (urine) outside of the body to provide information about a health condition (UTI).
- Device Description: The description further clarifies that it is an "in vitro diagnostic test device for qualitative detection of leukocyte and nitrite in urine."
- Performance Studies: The document details various performance studies, including precision, reproducibility, analytical specificity, sample carryover, assay reportable range, assay cut-off, and a lay user study. These are typical studies conducted for IVD devices to demonstrate their performance characteristics.
- Predicate Device: The mention of a predicate device (K231045; Healgen URS Test Strips) is common for IVD submissions, indicating a comparison to a previously cleared IVD device.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Safecare Urinary Tract Infection Test is for the qualitative detection of Leukocytes (LEU,white blood cells) and nitrite (NIT) in urine as an aid in the screening of a Urinary Tract infection (UTI). It is intended for over-the-counter home use.
Product codes
JMT, LJX
Device Description
Urinary Tract Infection Test is in vitro diagnostic test device for qualitative detection of leukocyte and nitrite in urine. The device is composed of two-color pads aligned on a strip. One pad is employed for testing leukocyte and the other for nitrite by visually reading the color change of the pad and comparing with the corresponding blocks on a color chart. The Safecare Urinary Tract Infection Test are for the qualitative detection of Leukocytes (white blood cells) and nitrite in urine as an aid in the screening of a Urinary Tract infection (UTI). It is intended for over-the-counter home use only.
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
Home use / Over-the-counter
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
Lay user Study:
Three (3) sites were selected to perform the lay-user studies. One hundred fifty-four (154) lay users with UTI symptoms were recruited to test their own urine sample using the Urinary Tract Infection Test. Laypersons performed one test with the Urinary Tract Infection Test according to the product insert and then collected a sample of their urine for comparison testing by healthcare professionals using the predicate device.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision and Reproducibility:
The precision study on the Safecare Urinary Tract hfection Test was performed at three (3) clinical sites with two (2) operators at each site. The evaluation included three (3) replicate assays over five (5) days with the midstream method. A total of forty-five (45) assays results on each of eight levels of control were obtained. All sample concentrations were were used with each level of control.
Analytical Specificity Interference:
Potentially interfering substances were added to negative urine with different leukocyte and nitrite concentrations. These samples were tested with three lots of the Safecare Urinary Tract by three different operators (one operator per lot). The following substances (Albumin, Ammonium Chloride, Ascorbic Acid, Bilirubin, Ciprofloxacin, Creatinine, Fructose, Glucose, Glucose, Glycine, Hemoglobin, Lactose, Oxalic Acid, Phenolphthalein, Potassium Chloride, Riboflavin, Sodium Nitrate, Sodium Phosphate, Sulfamethoxazole, Theophylline, Urea) showed no interference with the tests at the specified concentrations.
High glucose levels (>=1000 mg/dL) and high ascorbic acid (>=150 mg/dL) may decrease leukocyte readings. High ascorbic acid (>=150 mg/dL) may cause a false negative nitrite reading.
To investigate the effect of urine specific and urine pH, urine samples with specific gravity ranging from 1.000 to 1.035 and urine samples with pH ranging from pH of 5 to 9 were tested at different leukocyte and nitrite concentrations. The test results show that pH >8.0 may cause false positive leukocyte readings, and specific gravity >=1.035 may cause false negative leukocyte readings. There is no effect of both pH and specific gravity on nitrite testing.
Sample Carryover:
A sample carryover study was performed. Three (3) lots of testing. The study was performed by placing the moistened reagent strip (both by immersing it in the sample and simulating urination) vertically, either upwards, and hold for 10 seconds to allow the sample fluid to flow between the reaction pads on the strip (i.e., run-over for the leukocyte pad to the nitrite pad with the sample with high concentration of leakocyte and negative/normal concentration of nitrite to the leukocyte pad with the sample with high concentration of nitrite and negative/normal concentration of leukocyte), Testing was also repeated in the other direction. The study demonstrated that carryover (run-over) does not impact the test results.
Assay Reportable Range:
Leukocytes: qualitative: Negative, Trace, +, ++, +++; semi-quantitative: Negative, 0.0018, 0.0084,0.0015, 0.060(mg/mL)
Nitrite: qualitative: Negative, Positive
Traceability, Stability, Expected Values:
Traceability: The nitrite test is traceable to NIST SRM 8040 and the leukocyte pad is traceable to a commercially available solution.
Stability: The sponsor provided information to support that the device is stable for 24 months when stored at 4-30 °C based on real-time stability studies. The sponsor instructs the user to use the test strip immediately after the foil pouch is opened based on the results of the open-pouch stability study that demonstrated an open-pouch stability of 1 hour
Assay Cut-off:
A sensitivity study was performed to evaluate the lower limits of detection for each analyte on the URS Test Strips. Urine samples were spiked to known concentrations of each analyte. These samples were then diluted to the lowest positive concentrations that are indicated on the color chart. Each sample was tested in 30 replicates with three (3) different operators. The sponsor defined the LOD as the concentration of analyte that produces positive URS Test Strip results approximately 95% of the time. The results support the claim that the sensitivity of the leukocyte test is 0.0018mg/mL and the nitrite test is 0.05 mg/dL. The sponsor provided studies to support the recommended urination time (1-2 seconds) and the recommended reading time (2 minutes).
Comparison Studies:
Lay user Study:
Results from 154 subjects testing their own urine samples using the midstream collection method for leukocytes: the % Agreement (Exact Match) of each grad are: 90.00% (+++), 90.9% (++), 91.18% (+), 88.89% (Trace) and 100.0% (-), and for % Agreement (+/- Color Block), all grads are 100%.
Results from 154 subjects testing their own urine samples using the midstream collection method for nitrite: the %Agreement (Exact Match) are both 100% for positive (60 cases) and negative (94 cases).
Lay-users were also given surveys on the ease of understanding the package insert instructions. All lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis was performed on the score revealed a reading grade level of less than 7.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 0.0018mg/mL for leukocyte test, 0.05 mg/dL for nitrite test.
% Agreement (Exact Match) for leukocytes: 90.00% (+++), 90.9% (++), 91.18% (+), 88.89% (Trace) and 100.0% (-).
% Agreement (+/- Color Block) for leukocytes: all grads are 100%.
% Agreement (Exact Match) for nitrite: 100% for positive (60 cases) and negative (94 cases).
Predicate Device(s)
Reference Device(s)
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
§ 862.1510 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.
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January 10, 2025
Safecare Biotech (Hangzhou) Co., Ltd. Selina Zhang Manager 18 Haishu Road, Yuhang District Hangzhou, 311121 China
Re: K242767
Trade/Device Name: Safecare Urinary Tract Infection Test Regulation Number: 21 CFR 862.1510 Regulation Name: Nitrite (Nonquantitative) Test System Regulatory Class: Class I (meets the limitations of exemptions in 862.9(c)(9)) Product Code: JMT, LJX Dated: December 9, 2024 Received: December 9, 2024
Dear Selina Zhang:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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Paula Caposino, Ph.D. Deputy Division Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
K242767 Device Name
Safecare Urinary Tract Infection Test
Indications for Use (Describe)
The Safecare Urinary Tract Infection Test is for the qualitative detection of Leukocytes (LEU,white blood cells) and nitrite (NIT) in urine as an aid in the screening of a Urinary Tract infection (UTI). It is intended for over-the-counter home use.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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| 510(k) #: | K242767 |
|---|---|
| ----------- | --------- |
510(k) Summary
Prepared on: 2024-12-09
| Contact Details | |
|---|---|
| 21 CFR 807.92(a)(1) | |
| Applicant Name | Safecare Biotech (Hangzhou) Co., Ltd. |
| Applicant Address | 18 Haishu Road, Yuhang District Hangzhou, China Hangzhou 311121 China |
| Applicant Contact Telephone | 086-57181389219 |
| Applicant Contact | Ms. Selina Zhang |
| Applicant Contact Email | Dylan.wu921@gmail.com |
| Device Name | |
| 21 CFR 807.92(a)(2) | |
| Device Trade Name | Safecare Urinary Tract Infection Test |
| Common Name | Leukocyte peroxidase test |
| Classification Name | Nitrite (nonquantitative) test system |
| Regulation Number | 862.1510 |
| Product Code(s) | JMT, LJX |
Legally Marketed Predicate Devices 21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K231045 | Healgen URS Test Strips | LJX |
Device Description Summary 21 CFR 807.92(a)(4)
Urinary Tract Infection Test is in vitro diagnostic test device for qualitative detection of leukocyte and nitrite in urine. The device is composed of two-color pads aligned on a strip. One pad is employed for testing leukocyte and the other for nitrite by visually reading the color change of the pad and comparing with the corresponding blocks on a color chart. The Safecare Urinary Tract Infection Test are for the qualitative detection of Leukocytes (white blood cells) and nitrite in urine as an aid in the screening of a Urinary Tract infection (UTI). It is intended for over-the-counter home use only.
Intended Use/Indications for Use 21 CFR 807.92(a)(5)
The Safecare Urinary Tract Infection Test is for the qualitative detection of Leukocytes (LEU,white blood cells) and nitrite (NIT) in urine as an aid in the screening of a Urinary Tract infection (UTI). It is intended for over-the-counter home use.
Indications for Use Comparison 21 CFR 807.92(a)(5)
The device has the same indications for use in comparison to the predicate device.
Technological Comparison 21 CFR 807.92(a)(6)
The indications for use of proposed device is the same as predicate device K231045,i.e. For the detection of nitrite and leukocytes in urine.
The Nitrite test methodology of proposed device is the same as predicate device K231045, i.e. By conversion of nitrate to nitrite using the action of parsanilic acid to form a diazonium compound in an acid medium. This compound then couples with 1, 2, 3, 4 -
Safecare Urinary Tract Infection Test Page 27 of 39
5
tetrahydrobenzo(h) quinoline to produce a pink color.
The Leukocyte test methodology of proposed device is the same as predicate device K231045, i.e. By hydrolysis of an indoxyl ester derivative through the action of leukocyte esterase. The liberated indoxyl ester reacts with a diazonium salt to produce a colored compound (pink to purple).
The Specimen type of proposed device is the same as predicate device K231045, i.e. Human urine.
The Testing parameters of proposed device is the same as predicate device K231045, i.e. Nitrite and leukocytes.
The Conditions for Use of proposed device is the same as predicate device K231045, i.e. Over-the-Counter
The Test Read Time of proposed device is the same as predicate device K231045, i.e. 2 minutes for both nitrite and leukocytes.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
1.Precision and Reproducibility
The precision study on the Safecare Urinary Tract hfection Test was performed at three (3) clinical sites with two (2) operators at each site. The evaluation included three (3) replicate assays over five (5) days with the midstream method. A total of forty-five (45) assays results on each of eight levels of control were obtained. All sample concentrations were were used with each level of control.
2. Analytical Specificity Interference
Potentially interfering substances were added to negative urine with different leukocyte and nitrite concentrations. These samples were tested with three lots of the Safecare Urinary Tract by three different operators (one operator per lot). The following substances (Albumin, Ammonium Chloride, Ascorbic Acid, Bilirubin, Ciprofloxacin, Creatinine, Fructose, Glucose, Glucose, Glycine, Hemoglobin, Lactose, Oxalic Acid, Phenolphthalein, Potassium Chloride, Riboflavin, Sodium Nitrate, Sodium Phosphate, Sulfamethoxazole, Theophylline, Urea) showed no interference with the tests at the specified concentrations.
High glucose levels (≥1000 mg/dL) and high ascorbic acid (≥150 mg/dL) may decrease leukocyte readings. High ascorbic acid (≥150 mg/ dL) may cause a false negative nitrite reading.
To investigate the effect of urine specific and urine pH, urine samples with specific gravity ranging from 1.000 to 1.035 and urine samples with pH ranging from pH of 5 to 9 were tested at different leukocyte and nitrite concentrations. The test results show that pH >8.0 may cause false positive leukocyte readings, and specific gravity ≥1.035 may cause false negative leukocyte readings. There is no effect of both pH and specific gravity on nitrite testing.
To address the observed interference, the labeling indication (high specific gravity), high glucose, and high vitamin C (ascorbic acid) may interfere with results. The labeling also describes that urine with abnormal color (e.g., bright yellow or green) should not be tested.
Sample Carryover
A sample carryover study was performed. Three (3) lots of testing. The study was performed by placing the moistened reagent strip (both by immersing it in the sample and simulating urination) vertically, either upwards, and hold for 10 seconds to allow the sample fluid to flow between the reaction pads on the strip (i.e., run-over for the leukocyte pad to the nitrite pad with the sample with high concentration of leakocyte and negative/normal concentration of nitrite to the leukocyte pad with the sample with high concentration of nitrite and negative/normal concentration of leukocyte), Testing was also repeated in the other direction. The study demonstrated that carryover (run-over) does not impact the test results.
3.Assay Reportable Range
The results of the analytical studies support the following measurement ranges:
Leukocytes: qualitative: Negative, Trace, +, ++, +++; semi-quantitative: Negative, 0.0018, 0.0084,0.0015, 0.060(mg/mL) Nitrite: qualitative: Negative, Positive
- Traceability, Stability, Expected Values
Traceability
The nitrite test is traceable to NIST SRM 8040 and the leukocyte pad is traceable to a commercially available solution. Stability
The sponsor provided information to support that the device is stable for 24 months when stored at 4-30 °C based on real-time stability studies.
The sponsor instructs the user to use the test strip immediately after the foil pouch is opened based on the results of the open-pouch stability study that demonstrated an open-pouch stability of 1 hour
- Assay Cut-off
A sensitivity study was performed to evaluate the lower limits of detection for each analyte on the URS Test Strips. Urine samples were spiked to known concentrations of each analyte. These samples were then diluted to the lowest positive concentrations that are indicated on the color chart. Each sample was tested in 30 replicates with three (3) different operators. The sponsor defined the LOD as the concentration of analyte that produces positive URS Test Strip results approximately 95% of the time. The results support the claim that the sensitivity of the leukocyte test is 0.0018mg/mL and the nitrite test is 0.05 mg/dL. The sponsor provided studies to support the recommended urination time (1-2 seconds) and the recommended reading time (2 minutes).
6.Comparison Studies:
6
Lay user Study
Three (3) sites were selected to perform the lay-user studies. One hundred fifty-four (154) lay users with UTI symptoms were recruited to test their own urine sample using the Urinary Tract Infection Test. Laypersons performed one test with the Urinary Tract Infection Test according to the product insert and then collected a sample of their urine for comparison testing by healthcare professionals using the predicate device. The results obtained by the lay users using the Urinary Tract compared to the results obtained by the healthcare professionals using the predicate device are summarized below.
Results from 154 subjects testing their own urine samples using the midstream collection method for leukocytes: the % Agreement (Exact Match) of each grad are: 90.00% (+++), 90.9% (++), 91.18% (+), 88.89% (Trace) and 100.0% (-), and for % Agreement (+/- Color Block), all grads are 100%.
Results from 154 subjects testing their own urine samples using the midstream collection method for nitrite: the %Agreement (Exact Match) are both 100% for positive (60 cases) and negative (94 cases).
Lay-users were also given surveys on the ease of understanding the package insert instructions. All lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis was performed on the score revealed a reading grade level of less than 7.
Based on the test principle and performance characteristics of the device including precision/reproducibility, Analytical specificity/ Interference, Sample Carryover, assay cut-off and lay-user studies of the devices, it's concluded that Safecare Urinary Tract Infection Test is substantially equivalent to the predicate.