(65 days)
Not Found
No
The device description and performance studies indicate a simple visual color comparison method for interpreting results, with no mention of AI/ML or image processing.
No
This device is an in vitro diagnostic test for the qualitative detection of specific substances in urine to aid in screening for UTIs, not a device used for therapy or treatment.
Yes
The device is an in vitro diagnostic test for the qualitative detection of leukocytes and nitrite in urine, which aids in the screening of a Urinary Tract Infection (UTI). This aligns with the definition of a diagnostic device as it helps identify a disease or condition.
No
The device is a physical test strip with color pads that are visually read and compared to a color chart. It is an in vitro diagnostic test device, not a software application.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states "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)." This is a diagnostic purpose, analyzing a biological sample (urine) to provide information about a health condition (UTI).
- Device Description: It is described as "in vitro diagnostic test devices for qualitative detection of leukocyte and nitrite in urine." This directly labels the device as an in vitro diagnostic.
- Anatomical Site: The test is performed on "Urine," which is a biological sample taken from the body.
- Summary of Performance Studies: The studies described (Sensitivity, Precision, Analytical specificity, Method Comparison) are typical performance studies conducted for IVD devices to demonstrate their accuracy and reliability in detecting the target analytes in a biological sample.
- Predicate Device(s): The mention of a "Predicate Device(s)" with a K number (K100024 Teco Diagnostics UTI Test Strips) is a strong indicator that this device is being compared to another legally marketed IVD device for regulatory purposes.
All these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Healgen URS Test Strips 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.
Product codes (comma separated list FDA assigned to the subject device)
JMT, LJX
Device Description
Healgen URS Test Strips are in vitro diagnostic test devices 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.
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
over-the-counter home 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)
- Assay Cut-off:
- Assessed lower limits of detection for each analyte.
- Urine samples spiked to known concentrations, then diluted to lowest positive concentrations.
- Tested in duplicates with three device lots by five different operators.
- LOD values of 15 cells/uL for Leukocyte and 0.05 mg/dL for nitrite were verified.
- Precision/Reproducibility:
- Performed at three clinical sites with two operators at each site.
- Evaluation included three replicate assays over five days, generating 45 assay results for each of eight control levels.
- Three lots of the device were used.
- Leukocyte Results: 100% agreement with expected results for negative, trace (15), small (70), moderate (125), and large (500) concentrations.
- Nitrite Results: 100% agreement with expected results for 0.1 mg/dL (Positive) and 0.3 mg/dL (Positive).
- Leukocyte and Nitrite Results: 100% agreement for Leukocyte Small (70) and Nitrite 0.1 mg/dL (Positive).
- Analytical specificity:
- Potentially interfering substances added to negative urine with different leukocyte and nitrite concentrations.
- Tested with three lots by three different operators.
- Substances tested (and showed no interference at specified concentrations): Albumin (1000 mg/dL), Ammonium Chloride (400 mg/dL), Ascorbic Acid (100 mg/dL), Bilirubin (10 mg/dL), Ciprofloxacin (1 mg/dL), Creatinine (600 mg/dL), Fructose (18 mg/dL), Galactose (15 mg/dL), Glucose (500 mg/dL), Glycine (900 mg/dL), Hemoglobin (100 mg/dL), Lactose (29 mg/dL), Oxalic Acid (1 mg/dL), Phenazopyridine (30 mg/dL), Phenolphthalein (4 mg/dL), Potassium Chloride (1200 mg/dL), Riboflavin (50 mg/dL), Sodium Nitrate (10 mg/dL), Sodium Nitrite (10 mg/dL) for Leukocyte only, Sodium Phosphate (1000 mg/dL), Sulfamethoxazole (40 mg/dL), Theophylline (4 mg/dL), Urea (4000 mg/dL).
- High glucose (≥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.
- Effect of urine specific gravity and pH:
- pH >8.0 may cause false positive leukocyte readings.
- Specific gravity >1.035 may cause false negative leukocyte readings.
- No effect of pH and specific gravity on nitrite testing.
- Stability:
- Devices are stable at 2-30℃ for 24 months based on real-time stability studies.
- Method Comparison and Lay-user Studies:
- Study conducted at three sites.
- 150 lay users with UTI symptoms recruited to test their own urine samples.
- Laypersons performed one test with Healgen URS Test Strips according to the product insert.
- Urine samples then collected for comparison testing by healthcare professionals (predicate results).
- Agreement (Exact Match) for Leukocyte results between layperson and health professional:
- Large (3+): 90.9%
- Moderate (2+): 92%
- Small (1+): 89.7%
- Trace: 88.5%
- Negative: 98.3%
- Agreement (+/- Color Block) for Leukocyte results: 100% for all categories.
- Agreement for Nitrite (Positive/Negative) results: Positive: 100%, Negative: 100%.
- Lay-users indicated that device instructions can be easily followed.
- Flesch-Kincaid reading analysis of package insert showed a reading grade level of less than 7.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
LOD values of 15 cells/uL and 0.05 mg/dL are verified for Leukocyte and nitrite respectively.
Percentage Agreement from Lay-user Studies:
Leukocyte (Exact Match):
Large (3+): 90.9%
Moderate (2+): 92%
Small (1+): 89.7%
Trace: 88.5%
Negative: 98.3%
Leukocyte (+/- Color Block): 100% for all categories.
Nitrite (Exact Match):
Positive: 100%
Negative: 100%
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
§ 864.7675 Leukocyte peroxidase test.
(a)
Identification. A leukocyte peroxidase test is a device used to distinguish certain myeloid cells derived from the bone marrow, i.e., neutrophils, eosinophils, and monocytes, from lymphoid cells of the lymphatic system and erythroid cells of the red blood cell series on the basis of their peroxidase activity as evidenced by staining. The results of this test are used in the differential diagnosis of the leukemias.(b)
Classification. Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
0
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June 16, 2023
Healgen Scientific LLC % Joe Shia Director LSI International Inc. 504 East Diamond Ave., Suite I Gaithersburg, MD 20877
Re: K231045
Trade/Device Name: Healgen URS 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 862.9(c)(9)) Product Code: JMT, LJX Dated: April 7, 2023 Received: April 12, 2023
Dear Joe Shia:
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. 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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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-regulatoryassistance/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,
Image /page/1/Picture/6 description: The image contains the name "Paula V. Caposino-S" in a large, clear font. The text is arranged in two lines, with "Paula V." on the first line and "Caposino-S" on the second. The background is plain and light, ensuring the text is easily readable.
Paula Caposino, Ph.D. Acting 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
2
Indications for Use
510(k) Number (if known) K231045
Device Name Healgen URS Test Strips
Indications for Use (Describe)
The Healgen URS Test Strips 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.
| 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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3
510(k) SUMMARY K231045
| 1. | Date: | June 15, 2023 |
|---|---|---|
| 2. | Submitter: | Healgen Scientific LLC |
| 5213 Maple Street | ||
| Bellaire, TX77401 | ||
| 3. | Contact person: | Joe Shia |
| LSI International Inc. | ||
| 504 East Diamond Ave., Suite I | ||
| Gaithersburg, MD 20878 | ||
| Telephone: 240-505-7880 | ||
| Fax: 301-916-6213 | ||
| Email: shiajl@yahoo.com |
-
- Device Name: Healgen URS Test Strips
Classification: Class I (meets the limitations of exemptions in 862.9(c)(9))
| Product Code | CFR # | Panel |
|---|---|---|
| LJX | 21 CFR § 864.7675, Leukocyte Peroxidase Test System | Hematology |
| JMT | 21 CFR § 862.1510, Nitrite Test System | Chemistry |
-
- Predicate Devices: K100024 Teco Diagnostics UTI Test Strips
-
- Intended Use:
The Healgen URS Test Strips 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-thecounter home use only.
-
- Device Description:
Healgen URS Test Strips are in vitro diagnostic test devices for qualitative detection of leukocyte and nitrite in urine.
- Device Description:
4
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.
| Item | Device | Predicate – K100024 |
|---|---|---|
| Indication(s) | ||
| for use | For the detection of nitrite and | |
| leukocytes in urine. | Same | |
| Nitrite test | ||
| methodology | By conversion of nitrate to nitrite using | |
| the action of p- | ||
| arsanilic acid to form a diazonium | ||
| compound in an acid medium. This | ||
| compound then couples with 1, 2, 3, 4- | ||
| tetrahydrobenzo( h ) quinoline to produce | ||
| a pink color. | Same | |
| Leukocyte test | ||
| methodology | 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). | Same | |
| Specimen | ||
| Type | Human urine | Same |
| Testing | ||
| parameters | Nitrite and leukocytes | Same |
| Conditions for | ||
| Use | Over-the-Counter | Same |
| Test Read | ||
| Time | 2 minutes for both nitrite and leukocytes | 2 minutes for leukocytes |
| 1 minute for nitrite |
-
- Substantial Equivalence Information
9. Test Principle
The Healgen URS Test Strips measure the color developed in 2 reaction zones (leukocytes and nitrite pads) on the test strips following application of a urine sample. The developed colors are then compared to calibration colors located on the Healgen color chart card and the result for each pad is determined based on the minimum color distance between the developed colors and calibration colors.
The leukocytes test is using the hydrolysis of an indoxy] 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).
5
The Nitrite test uses the conversion of nitrate to nitrite by the action of p-arsanilic acid to form a diazonium compound in an acid medium. This compound then couples with 1, 2, 3, 4-tetrahydrobenzo (h) quinoline to produce a pink color.
10. Performance Characteristics
-
- 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 duplicates with three device lots by five different operators.
- Assay Cut-off
| Leukocyte Concentration
| (cells/µL) | Negative | Positive | Limit of Detection |
|---|---|---|---|
| 30 | 0 | 30 | 100% |
| 15 | 0 | 30 | 100% |
| 10 | 16 | 14 | 47% |
| 5 | 28 | 2 | 7% |
| 3 | 30 | 0 | 0 |
| Nitrite Concentration | Negative | Positive | Limit of Detection |
|---|---|---|---|
| (mg/dL) | |||
| 0.1 | 0 | 30 | 100% |
| 0.08 | 0 | 30 | 100% |
| 0.06 | 5 | 25 | 83% |
| 0.05 | 15 | 15 | 50% |
| 0.04 | 30 | 0 | 0 |
LOD values of 15 cells/uL and 0.05 mg/dL are verified for Leukocyte and nitrite respectively.
2. Precision/Reproducibility
The precision study on the URS Test Strips was performed at three clinical sites with two operators at each site. The evaluation included three replicate assays over five days. A total of forty-five assays results on each of eight levels of control were obtained. All sample concentrations were masked.
6
Three lots of the device were used with each level of control. The obtained results are listed in the following tables.
Leukocyte Results:
| Control | Expected
Range | N | % Agreement
with
Expected Results |
|----------|-------------------|----|-----------------------------------------|
| Negative | Negative | 45 | 100 |
| Trace | 15 | 45 | 100 |
| Small | 70 | 45 | 100 |
| Moderate | 125 | 45 | 100 |
| Large | 500 | 45 | 100 |
Nitrite Results:
| Control Sample | Expected
Value | N | % Agreement
with
Expected Results |
|----------------|-------------------|----|-----------------------------------------|
| 0.1 mg/dL | Positive | 45 | 100% |
| 0.3 mg/dL | Positive | 45 | 100% |
Leukocyte and Nitrite Results:
| Control Sample | | Expected
Value | N | % Agreement
with
Expected
Results |
|----------------|-----------|-------------------|----|--------------------------------------------|
| Leukocyte | Small | 70 | 45 | 100% |
| Nitrite | 0.1 mg/dL | Positive | 45 | 100% |
-
- Analytical specificity
Potentially interfering substances were added to negative urine with different leukocyte and nitrite concentrations. These samples were tested with three lots of the Healgen URS Test Strips by three different operators. The following substances 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.
- Analytical specificity
| Substances | Testing Concentration (mg/dL) |
|---|---|
| Albumin | 1000 |
| Ammonium Chloride | 400 |
| Ascorbic Acid | 100 |
| Bilirubin | 10 |
| Ciprofloxacin | 1 |
7
| Creatinine | 600 |
|---|---|
| Fructose | 18 |
| Galactose | 15 |
| Glucose | 500 |
| Glycine | 900 |
| Hemoglobin | 100 |
| Lactose | 29 |
| Oxalic Acid | 1 |
| Phenazopyridine | 30 |
| Phenolphthalein | 4 |
| Potassium Chloride | 1200 |
| Riboflavin | 50 |
| Sodium Nitrate | 10 |
| Sodium Nitrite* | 10 |
| Sodium Phosphate | 1000 |
| Sulfamethoxazole | 40 |
| Theophylline | 4 |
| Urea | 4000 |
- This interference is tested for Leukocyte results only.
To investigate the effect of urine specific gravity and urine pH, urine samples, with 1.000 to 1.035 specific gravity or urine samples with pH 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.
4. Stability
The devices are stable at 2-30℃ for 24 months based on real-time stability studies.
-
- Method Comparison and Lay-user Studies
Three sites were selected to perform the lay-user studies. 150 lay users with UTI symptoms were recruited to test her/his own urine sample using the Healgen URS Test Strips. Laypersons performed one test with the Healgen URS Test Strips according to the product insert and then collected a sample of their urine for comparison testing by healthcare professionals.
- Method Comparison and Lay-user Studies
The results obtained by the lay users compared to the results obtained by the healthcare professionals are summarized below:
8
| Predicate Results by
| Health Professionals | ||||||
|---|---|---|---|---|---|---|
| Layperson | ||||||
| Results | Large | |||||
| (3+) | Moderate | |||||
| (2+) | Small | |||||
| (1+) | Trace | Negative | Total | |||
| Large (3+) | 10 | 0 | 0 | 0 | 0 | 10 |
| Moderate (2+) | 1 | 23 | 0 | 0 | 0 | 24 |
| Small (1+) | 0 | 2 | 26 | 1 | 0 | 29 |
| Trace | 0 | 0 | 3 | 23 | 1 | 27 |
| Negative | 0 | 0 | 0 | 2 | 58 | 60 |
| Total | 11 | 25 | 29 | 26 | 59 | 150 |
| % Agreement (Exact Match) | 90.9 | 92 | 89.7 | 88.5 | 98.3 | |
| % Agreement (+/- Color Block) | 100 | 100 | 100 | 100 | 100 |
| Predicate Results by Health
| Professionals | Positive | Negative | Overall |
|---|---|---|---|
| Layperson Results | |||
| Positive | 32 | 0 | 32 |
| Negative | 0 | 118 | 118 |
| Total | 32 | 118 | 150 |
| % Agreement (Exact Match) | 100 | 100 |
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 package insert and the score revealed a reading grade level of less than 7.
-
- Clinical Studies
Not applicable.
- Clinical Studies
9
11. Conclusion
Based on the test principle and performance characteristics of the device including LOD, precision, interference, method comparison and lay-user studies of the devices, it's concluded that Healgen URS Test Strips is substantially equivalent to the predicate.