Healgen® URS Test Strips
Device Facts
| Record ID | K251800 |
|---|---|
| Device Name | Healgen® URS Test Strips |
| Applicant | Healgen Scientific,, LLC |
| Product Code | JMT · Clinical Chemistry |
| Decision Date | Dec 23, 2025 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1510 |
| Device Class | Class 1 |
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.
Device Story
Healgen® URS Test Strips are in vitro diagnostic devices for qualitative detection of leukocytes and nitrites in human urine. Device consists of two color-reactive pads on a strip. User dips strip in urine; color change occurs after 2 minutes. User visually compares pad colors against a provided color chart. Leukocyte detection uses hydrolysis of indoxyl ester derivative via leukocyte esterase, reacting with diazonium salt to produce pink/purple color. Nitrite detection uses conversion of nitrate to nitrite via p-arsanilic acid, forming a diazonium compound that couples with 1,2,3,4-tetrahydrobenzo(h)quinoline to produce a pink color. Intended for over-the-counter home use by patients to screen for UTI. Results provide immediate visual feedback to assist in clinical decision-making regarding potential infection.
Clinical Evidence
Bench testing included sensitivity (LOD: 10 cells/μL leukocytes, 0.05 mg/dL nitrite), precision (100% agreement across 45 replicates), and analytical specificity (no interference from 35 substances, though high glucose/ascorbic acid may affect results). Method comparison study (n=234) against K111999 showed high agreement (exact match >95% for most levels). Lay-user study (n=234) confirmed that non-professionals could correctly perform the test and interpret results with high agreement compared to healthcare professionals. Flesch-Kincaid analysis confirmed package insert readability (grade level <8).
Technological Characteristics
The device consists of reagent-impregnated pads on a strip. Nitrite detection uses p-arsanilic acid and 1,2,3,4-tetrahydrobenzo(h)quinoline. Leukocyte detection uses an indoxyl ester derivative and a diazonium salt. The device is a qualitative/semi-quantitative visual test with a 2-minute read time. It is stable for 24 months at 2-30°C and has an open-pouch stability of 2 hours. No electronic components, software, or connectivity features are present.
Indications for Use
Indicated for individuals with symptoms of a urinary tract infection (UTI) for the qualitative detection of leukocytes and nitrite in urine to aid in screening.
Regulatory Classification
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.
Predicate Devices
- Healgen URS Test Strips (K231045)
Related Devices
- K231045 — Healgen URS Test Strips · Healgen Scientific,, LLC · Jun 16, 2023
- K100024 — TECO DIAGNOSTICS UTI DETECTION STRIPS · Teco Diagnostics · Feb 17, 2011
Submission Summary (Full Text)
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FDA
U.S. FOOD & DRUG
ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
ASSAY ONLY
## I Background Information:
A 510(k) Number
K251800
B Applicant
Healgen Scientific LLC
C Proprietary and Established Names
Healgen® URS Test Strips
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| LJX | Class I, meets the limitations of exemptions in 21 CFR 862.9 (c)(9) | 21 CFR 864.7675 - Leukocyte Peroxidase Test | HE - Hematology |
| JMT | Class I, meets the limitations of exemptions in 21 CFR 862.9 (c)(9) | 21 CFR 862.1510 - Nitrite (nonquantitative) test system | CH - Clinical Chemistry |
## II Submission/Device Overview:
A Purpose for Submission:
Modified Device
B Measurand:
Urine leukocytes and nitrite
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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C Type of Test:
Qualitative and semi-quantitative urinalysis
III Intended Use/Indications for Use:
A Intended Use(s):
See Indications for Use below.
B Indication(s) 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.
C Special Conditions for Use Statement(s):
OTC - Over the Counter
D Special Instrument Requirements:
Not applicable
IV Device/System Characteristics:
A Device Description:
Same as described in K231045. The device was modified to add dipping as a testing method.
B Principle of Operation:
Same as described in K231045.
V Substantial Equivalence Information:
A Predicate Device Name(s):
Healgen URS Test Strips
B Predicate 510(k) Number(s):
K231045
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C Comparison with Predicate(s):
| Device & Predicate Device(s): | K251800 | K231045 |
| --- | --- | --- |
| Device Trade Name | Healgen® URS Test Strips | Healgen URS Test Strips |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | For the qualitative detection of leukocytes and nitrite in urine. | Same |
| Sample Type | Human Urine | Same |
| Analytes | Nitrite, Leukocyte | 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 |
| Conditions for use | Over-the-counter | Same |
| Read time | 2 minutes | Same |
| General Device Characteristic Differences | | |
| Testing Format | Dipping | Midstream |
VI Standards/Guidance Documents Referenced:
None were referenced.
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VII Performance Characteristics (if/when applicable):
# A Analytical Performance:
# 1. Precision/Reproducibility:
The precision study for the Healgen URS Test Strips was performed at three testing sites with one operator at each site. The evaluation included three runs per day for five days. Three lots of the reagent were used with each level of control samples in each run. A total of forty-five results (3x3x5) on each concentration were obtained. All sample concentrations were masked. The results are listed in the tables below.
| Analyte | Concentration | Expected Value | N | % Agreement with Expected results |
| --- | --- | --- | --- | --- |
| Leukocyte | 0 cells/μL | Negative | 45 | 100 |
| | 15 cells/μL | Trace (15) | 45 | 100 |
| | 70 cells/μL | Small (70) | 45 | 100 |
| | 125 cells/μL | Moderate (125) | 45 | 100 |
| | 500 cells/μL | Large (500) | 45 | 100 |
| Nitrite | 0 mg/dL | Negative | 45 | 100 |
| | 0.08 mg/dL | Positive | 45 | 100 |
| | 0.1 mg/dL | Positive | 45 | 100 |
# 2. Linearity:
Not applicable.
# 3. Analytical Specificity/Interference:
Potentially interfering substances were added to negative urine or urine with different analyte 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.
| Substances | Testing Concentration (mg/dL) |
| --- | --- |
| Albumin | 1000 mg/dL |
| Ascorbic Acid | 100 mg/dL |
| Hemoglobin | 100 mg/dL |
| Citric Acid | 50 mg/dL |
| Bilirubin | 10 mg/dL |
| Ciprofloxacin | 1 mg/dL |
| Creatine | 8 mg/dL |
| Acetoacetate Acid | 1 mmol/L |
| Ammonium Chloride | 400 mg/dL |
| Calcium Chloride | 50 mg/dL |
| Creatinine | 800 mg/dL |
| Galactose | 80 mg/dL |
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| Substances | Testing Concentration (mg/dL) |
| --- | --- |
| Glucose | 500 mg/dL |
| Glycine | 1000 mg/dL |
| KCL | 1500 mg/dL |
| NaCl | 2800 mg/dL |
| Oxalic Acid | 70 mg/dL |
| Sodium Acetate | 1200 mg/dL |
| Sodium Bicarbonate | 1500 mg/dL |
| Sodium Nitrate | 10 mg/dL |
| Sodium Nitrite* | 10 mg/dL |
| Sodium Phosphate | 1000 mg/dL |
| Sulfamethoxazole | 40 mg/dL |
| Urobilinogen | 3.0 mg/dL |
| Urea | 4000 mg/dL |
| Riboflavin | 50 mg/dL |
| Theophylline | 100 mg/dL |
| Phenolphthalein | 120 mg/dL |
| Phenazopyridine | 30 mg/dL |
| Glutathione | 200 mg/dL |
| Hypochlorite | 1 mg/dL |
| Hydrochloric Acid | 1 mg/dL |
| Peroxide | 0.1mg/dL |
| Atropine | 30 mg/dL |
| Fructose | 5000 mg/dL |
| Lactose | 5000 mg/dL |
| Ketone | 200 mg/dL |
| Mesna | 50 mg/dL |
* This interference is tested for Leukocyte results only.
High glucose levels (≥1000 mg/dL) or high Vitamin C (≥150 mg/dL) may decrease leukocyte readings. High Vitamin C (≥150 mg/dL) may cause a false negative nitrite reading.
To investigate the effect of urine specific gravity and urine pH, urine samples, with 1.005 to 1.035 specific gravity or urine samples with pH 5 to 8.5 were tested at different analytes concentrations. The test results show that there is no effect of both pH and specific gravity on leukocyte, nitrite and blood tests.
## Sample Carryover
A sample carryover study was performed. Three (3) lots of test strips were used for testing. The study was performed by dipping the test strip into the sample and holding the test strip vertically upward or downward for 10 seconds to allow the sample flow from one pad to the other pad (e.g., run-over for the leucocyte pad to the nitrite pad with a sample with a high concentration of leukocyte and runover for the nitrite to the leukocyte pad with a sample with a high concentration of nitrite). Testing was also repeated in the other direction. The study demonstrated that carryover (run-over) does not impact the test results.
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# 4. Assay Reportable Range:
The sponsor provided the following measurement ranges in the labeling:
| Analyte | Measurement range |
| --- | --- |
| Leukocytes | qualitative: Negative, Trace, +, ++, +++
semi-quantitative: Negative, 15, 70, 125, 500 (cells/μL) |
| Nitrite | qualitative: Negative, Positive |
# 5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
## Traceability
The nitrite test is traceable to NIST SRM di-Sodium oxalate 8040a, 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 2-30°C based on real-time stability studies. The package insert recommends that users store the strips at 15-30°C (59-86°F).
The sponsor instructs the user to use the test strip immediately after the pouch is opened, based on the results of an open-pouch stability study that demonstrated an open-pouch stability of 2 hours.
# 6. Detection Limit:
See Assay Cut-off section below.
# 7. Assay Cut-Off:
A sensitivity study was performed to evaluate the lower limits of detection for each analyte on the Healgen 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 duplicate with three reagent lots by five different operators for a total of 30 measurements per sample.
The sponsor defined the limit of detection (LOD) as the concentration of analyte that produces positive Healgen URS Test Strips results ≥50% of the time. The results support the claim that the sensitivity of the leukocyte test is 15 cells/μL and the sensitivity of the nitrite test is 0.05 mg/dL.
The sponsor also provided studies to support the recommended dipping time (1-2 seconds) and the recommended reading time (2 minutes).
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B Comparison Studies:
1. Method Comparison with Predicate Device:
Lay-user Study
Three sites were selected to perform the lay-user studies. 234 lay users with UTI symptoms were recruited to test their 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 using the comparator device. The results obtained by the lay users compared to the results obtained by the healthcare professionals are summarized below.
Comparison Results between Lay-user using Subject Device and Health Professionals using comparator device
Leukocytes
| HCP Lay User | 500 (3+) | 125 (2+) | 70 (1+) | 15 (±) | Negative | Total |
| --- | --- | --- | --- | --- | --- | --- |
| 500 (3+) | 13 | 0 | 0 | 0 | 0 | 13 |
| 125 (2+) | 1 | 42 | 1 | 0 | 0 | 44 |
| 70 (1+) | 0 | 2 | 54 | 2 | 0 | 58 |
| 15(±) | 0 | 0 | 2 | 32 | 2 | 36 |
| Negative | 0 | 0 | 0 | 0 | 83 | 83 |
| Total | 14 | 44 | 57 | 34 | 85 | 234 |
| % Agreement (Exact Match) | 92.9 | 95.5 | 94.7 | 94.1 | 97.6 | |
| % Agreement (+/- Color Block) | 100 | 100 | 100 | 100 | 100 | |
Nitrite
| HCP Lay User | Positive | Negative | Overall |
| --- | --- | --- | --- |
| Positive | 100 | 0 | 100 |
| Negativ e | 0 | 134 | 134 |
| Total | 100 | 134 | 234 |
| % Agreement (Exact Match) | 100 | 100 | |
| % Agreement (+/- Color Block) | 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 8.
K251800 - Page 7 of 9
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2. Matrix Comparison:
Not Applicable.
# C Clinical Studies:
1. Clinical Sensitivity:
Not Applicable.
2. Clinical Specificity:
Not Applicable.
3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
Not Applicable.
# D Clinical Cut-Off:
Not Applicable.
# E Expected Values/Reference Range:
The following information is provided in the labeling:
| TEST STRIP RESULTS | | RECOMMENDATIONS |
| --- | --- | --- |
| Leukocytes (LEU) | Nitrite (NIT) | |
| Negative | Negative | No sign of UTI detected. However, if you still have symptoms, consult your physician; there are some cases of UTI that the test may not detect. |
| Trace | Negative | Results suggest additional testing is required. Test again the following day with a new strip. If you have symptoms or if you get another trace leukocyte result, consult your physician. |
| Negative or Trace | Positive | Results suggest a sign of a UTI. Consult your physician immediately. |
| Positive +, ++,+++ | Positive | Results suggest a sign of a UTI. Consult your physician immediately. |
| Positive +, ++,+++ | Negative | Results suggest a sign of a UTI. Repeat the test next time you urinate using a new test strip. Make sure to wash the genital area first. If LEU is still positive, consult your physician. |
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VIII Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.
IX Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
K251800 - Page 9 of 9
