ACR LAB Urine Analysis Test System

K182384 · Healthy.Io, Ltd. · JFY · Jul 26, 2019 · Clinical Chemistry

Device Facts

• Record ID: K182384
• Device Name: ACR LAB Urine Analysis Test System
• Applicant: Healthy.Io, Ltd.
• Product Code: JFY · Clinical Chemistry
• Decision Date: Jul 26, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1225
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

AI Performance

Output	Acceptance	Observed	Dev DS	Test DS
Albumin concentration in urine	Not specified	Exact match agreement: 92.0% (10 mg/L), 80.2% (30 mg/L), 87.5% (80 mg/L), 92.2% (150 mg/L); ±1 color block agreement: 100% for all levels	Not specified	Method comparison study: 375 subjects (plus 60 spiked samples) across three sites, total 434 samples
Creatinine concentration in urine	Not specified	Exact match agreement: 86.1% (10 mg/dL), 82.0% (50 mg/dL), 82.8% (100 mg/dL), 81.4% (200 mg/dL), 92.2% (300 mg/dL); ±1 color block agreement: 100% for all levels	Not specified	Method comparison study: 375 subjects (plus 60 spiked samples) across three sites, total 440 samples
Albumin-to-Creatinine Ratio (ACR)	Not specified	Exact agreement: 92.0% (Normal), 92.6% (Abnormal), 98.1% (High-Abnormal); Overall exact agreement: 92.86%	Not specified	Method comparison study: 375 subjects (plus 60 spiked samples) across three sites, total 434 samples

Indications for Use

The ACR | LAB Urine Analysis Test System is comprised of a smartphone application, a proprietary Color-Board, and ACR Reagent Strips. It is intended for the semi-quantitative detection of albumin and creatinine in urine, as well as the presentation of their ratio. The ACR | LAB Urine Analysis Test System is intended for in-vitro diagnostic use by a healthcare professional in a point of care setting. These results may be used in conjunction with clinical evaluation as an aid in the diagnosis for kidney function.

Device Story

System uses smartphone camera to capture images of urine-dipped reagent strips placed on proprietary Color-Board; Color-Board provides reference for color calibration. App guides professional user through testing process; performs boundary condition analysis on captured images. If scan approved, images sent to cloud-based Backend server for analysis; image recognition algorithm classifies results. Results transmitted to patient Electronic Medical Record (EMR) for clinician review. Device used in point-of-care settings by healthcare professionals; patients do not access results. System provides semi-quantitative albumin and creatinine levels and ratio to assist in kidney function assessment.

Clinical Evidence

Clinical study at three U.S. sites with 375 subjects and 60 contrived samples. Compared ACR | LAB (iPhone 7) results against predicate (Mission U120 Ultra). Primary endpoints: percent exact match and ±1 color block agreement. Results: 89% exact match for albumin, 84% for creatinine, 93% for ratio. Agreement within ±1 color block was 100% for all metrics. Analytical testing included precision (repeatability/reproducibility), interference, limit of detection, linearity, and timing flex studies, all confirming performance.

Technological Characteristics

Reflectance photometry using ACON Mission Urinalysis Reagent Strips. System comprises iPhone 7 (iOS 12.0), proprietary Color-Board, and cloud-based image recognition software. Connectivity via internet to cloud server and EMR. No calibration required. Software performs image analysis of colorimetric patches on strips against Color-Board reference.

Indications for Use

Indicated for healthcare professionals in point-of-care settings to detect albumin and creatinine in human urine and calculate their ratio to aid in kidney function diagnosis. Prescription use only. Contraindicated for samples with blood levels >= 80 erythrocytes/microliter (>= 2+) or visible color interferents.

Regulatory Classification

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.

Predicate Devices

• Mission U120 Ultra Urine Analyzer and Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) (k142391)

Reference Devices

• Mission Urinalysis Reagent Strips U031-021 (k150330)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE

A. 510(k) Number:
k182384

B. Purpose for Submission:
New device

C. Measurand:
Albumin and creatinine in urine

D. Type of Test:
Semi-quantitative urinalysis

E. Applicant:
Healthy.io, Ltd.

F. Proprietary and Established Names:
ACR | LAB Urine Analysis Test System

G. Regulatory Information:

1. Regulation section:
| Name | Regulation | Product Code | Device Class |
| --- | --- | --- | --- |
| Creatinine test system | 21 CFR 862.1225 | JFY | II |
| Urinary protein or albumin (nonquantitative) test system | 21 CFR 862.1645 | JIR | I |
| Automated urinalysis system | 21 CFR 862.2900 | KQO | I |

2. Panel:
Chemistry (75)

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H. Intended Use:

1. Intended use(s):

See Indication(s) for use below.

2. Indication(s) for use:

The ACR | LAB Urine Analysis Test System is comprised of a smartphone application, a proprietary Color-Board, and ACR Reagent Strips. It is intended for the semi-quantitative detection of albumin and creatinine in urine, as well as the presentation of their ratio. The ACR | LAB Urine Analysis Test System is intended for in-vitro diagnostic use by a healthcare professional in a point of care setting. These results may be used in conjunction with clinical evaluation as an aid in the diagnosis for kidney function.

3. Special conditions for use statement(s):

For prescription use only.

For in vitro diagnostic use only.

Samples should be screened for blood prior to testing.

4. Special instrument requirements:

A dedicated iPhone 7 (iOS 12.0) should be used for testing.

I. Device Description:

The device is provided as a kit that comprises a canister of 100 ACON Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) (ACON Laboratories Inc., k150330), 10 individually-wrapped Color-Boards, and a User Manual. The ACR | LAB Urine Analysis Test System also consists of a smartphone application for use on a dedicated iPhone 7 (iOS 12.0), and an image recognition algorithm running on a back-end, cloud-based server.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Mission U120 Ultra Urine Analyzer and Mission Urinalysis Reagent Strips (Microalbumin/Creatinine)

2. Predicate 510(k) number(s):

k142391

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3. Comparison with predicate:

| Similarities |
| --- |
| Item | Subject Device k182384 ACR | LAB Urine Analysis Test System | Predicate Device k142391 Mission U120 Ultra Urine Analyzer and Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) |
| Intended Use | For the semi quantitative measurement of albumin and creatinine to assist diagnosis for kidney function. | Same |
| Sample Type | Human urine | Same |
| Measurement Principle | Reflectance photometry | Same |
| Differences |
| --- |
| Item | Subject Device k182384 ACR | LAB Urine Analysis Test System | Predicate Device k142391 Mission U120 Ultra Urine Analyzer and Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) |
| Reader | iPhone 7 (iOS 12.0) | Mission U120 Ultra Urine Analyzer |
| Data Transfer | Internet connection between the dedicated smartphone, back-end server, and patient's electronic medical records | USB port and standard RS232C port |

K. Standard/Guidance Document Referenced (if applicable):

- IEC 62304:2006, Medical device software - Software life cycle processes
- 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 EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition

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# L. Test Principle:

The albumin test is based on affinity binding of albumin to a sulfonephthalein dye at a constant pH. The development of pale green to aqua blue indicates the presence of albumin. The creatinine test is based on the peroxidase-like activity of a copper creatinine complex that catalyzes the reaction of diisopropylbenzene dihydroperoxide and $3,3^{\prime},5,5^{\prime}$ -tetramethylbenzidine. The resulting color ranges from orange through green to blue.

The ACR | LAB Urine Analysis Test System scans and analyzes the test strip using a mobile device running the smartphone application.

# M. Performance Characteristics (if/when applicable):

# 1. Analytical performance:

# a. Precision/Reproducibility:

Repeatability testing was conducted at 3 sites using one iPhone 7 (iOS 12.0) smartphone at each site. Each site had one operator performing the tests using 3 spiked urine samples, 3 strip lots, and 7 test strips per lot for a total of 63 results per level across sites (21 per site). The results are summarized by site in the tables below.

Albumin

| Level (mg/L) | N | Within Run % Agreement (Exact Match) Site 1 | Within Run % Agreement (Exact Match) Site 2 | Within Run % Agreement (Exact Match) Site 3 | % Agreement (±1 Color Block) |
| --- | --- | --- | --- | --- | --- |
| 10 | 63 | 100% (21/21) | 100% (21/21) | 100% (21/21) | 100% (63/63) |
| 30 | 63 | 100% (21/21) | 100% (21/21) | 100% (21/21) | 100% (63/63) |
| 150 | 63 | 100% (21/21) | 100% (21/21) | 100% (21/21) | 100% (63/63) |

Creatinine

| Level (mg/dL) | N | Within Run % Agreement (Exact Match) Site 1 | Within Run % Agreement (Exact Match) Site 2 | Within Run % Agreement (Exact Match) Site 3 | % Agreement (±1 Color Block) |
| --- | --- | --- | --- | --- | --- |
| 10 | 63 | 100% (21/21) | 100% (21/21) | 100% (21/21) | 100% (63/63) |
| 50 | 63 | 100% (21/21) | 100% (21/21) | 100% (21/21) | 100% (63/63) |
| 300 | 63 | 100% (21/21) | 100% (21/21) | 100% (21/21) | 100% (63/63) |

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Reproducibility testing was conducted at 3 sites using five iPhone 7 (iOS 12.0) smartphones at each site. Each site had one operator performing the tests using 3 spiked urine samples, 3 strip lots, and 2 runs per day in singlicate over 20 days for a total of 360 results per level across sites (120 per site). The results are summarized by site in the tables below.

Albumin

| Level (mg/L) | N | % Agreement (Exact Match) | % Agreement (± 1 Color Block) |
| --- | --- | --- | --- |
| 10 | 360 | 100% (360/360) | 100% (360/360) |
| 30 | 360 | 100% (360/360) | 100% (360/360) |
| 150 | 360 | 99.7% (359/360) | 100% (360/360) |

Creatinine

| Level (mg/dL) | N | % Agreement (Exact Match) | % Agreement (± 1 Color Block) |
| --- | --- | --- | --- |
| 10 | 360 | 100% (360/360) | 100% (360/360) |
| 50 | 360 | 98.9% (356/360) | 100% (360/360) |
| 300 | 360 | 100% (360/360) | 100% (360/360) |

b. Linearity/assay reportable range:

The reportable range for each analyte was evaluated by measuring five levels of creatinine (10, 50, 100, 200, and 300 mg/dL) and four levels of albumin (10, 30, 80, and 150 mg/L). The study was performed by 3 operators using 3 lots of test strips in replicates of 10 per lot for a total of 90 measurements per sample. Each operator used one iPhone 7 (iOS 12.0).

Albumin

| Block Cut-off (mg/L) | Concentrations Tested (mg/L) | % Exact Match | % ± 1 Color Block |
| --- | --- | --- | --- |
| 10 | 6-14 | 100 | 100 |
| 30 | 18-50 | 100 | 100 |
| 80 | 60-108 | 98.89 | 100 |
| 150 | > 122 | 100 | 100 |

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Creatinine

| Block Cut-off (mg/dL) | Concentrations Tested (mg/dL) | % Exact Match | % ± 1 Color Block |
| --- | --- | --- | --- |
| 10 | 6-26 | 100 | 100 |
| 50 | 34-70 | 97.78 | 100 |
| 100 | 80-140 | 98.89 | 100 |
| 200 | 160-240 | 98.89 | 100 |
| 300 | > 260 | 100 | 100 |

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Traceability:

The device is traceable to a commercially available method.

d. Detection limit:

A limit of detection study was conducted to determine the cut-off points for every color block for both albumin and creatinine. Urine samples spiked with albumin (6 mg/L to 210 mg/L) or creatinine (6 mg/dL to 420 mg/dL) were each tested using 3 test strip lots and 6 replicates per lot using one iPhone 7 (iOS 12.0) smartphone. The cut-off for each color block is defined as the lowest concentration at which over 55% of the test results were positive. The results of the study are shown below.

Albumin

| Color Block (mg/L) | Cut-off Concentration (mg/L) | (% positive) |
| --- | --- | --- |
| 10 | 6 | 100 |
| 30 | 18 | 66.7 |
| 80 | 60 | 55.56 |
| 150 | 122 | 66.7 |

Creatinine

| Color Block (mg/dL) | Cut-off Concentration (mg/dL) | (% positive) |
| --- | --- | --- |
| 10 | 6 | 100 |
| 50 | 34 | 83.33 |
| 100 | 80 | 66.67 |
| 200 | 160 | 55.56 |
| 300 | 260 | 66.67 |

e. Analytical specificity:

Interference

Urine samples spiked with albumin (10 mg/L, 30 mg/L, 150 mg/L) or creatinine (10

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mg/dL, 50 mg/dL, 300 mg/dL) were spiked with each potentially interfering substance at low and high concentrations or not spiked (control). Each sample was tested with 1 lot of test strips with 8 replicates using one iPhone 7 (iOS 12.0) smartphone. Interference was defined as a change in output of one or more color blocks between spiked and control samples. When interference was observed, further testing was conducted to identify the lowest concentration at which interference was observed.

The interferents and the highest concentrations tested are listed in the table below:

| Substance | Highest Concentration Tested (mg/dL) | Substance | Highest Concentration Tested (mg/dL) |
| --- | --- | --- | --- |
| Lithium acetoacetate | 250 | Sodium chloride | 5500 |
| Ammonium chloride | 100 | Oxalic acid | 70 |
| Ascorbic acid | 200 | Sodium acetate | 2.25 |
| Uric acid | 150 | Riboflavin | 10 |
| Unconjugated bilirubin | 170 | Sodium bicarbonate | 1500 |
| Calcium chloride | 275 | Sodium nitrate | 10 |
| Creatine | 10 | Sodium nitrite | 10 |
| Creatinine | 600 | Sodium phosphate | 500 |
| Fructose | 100 | Theophylline | 100 |
| Galactose | 80 | Urea | 400 |
| Glycine | 450 | Blood | 0.05% |
| Glucose | 5000 | Leucocytes | 2500 |
| Lactose | 10 | Human IgG | 25 |
| Hemolysate | 10 | Citric acid | 75 |
| Potassium chloride | 1500 | | |
| Glycine | 450 | | |

The following table shows the substances that interfered with the proposed device. Results are expressed as the lowest concentration of the interfering substance that exhibited interference and the resulting change in output of the color block. The lowest concentration causing interference will be included in the ACR | LAB Urine Analysis Test System user manual.

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Albumin

| Interferent | Lowest Concentration Interference was Observed | Analyte Level | Affect on Results |
| --- | --- | --- | --- |
| Hemoglobin | 2.13 mg/dL | 10 mg/L | Falsely elevated by one color block |
| | | 30 mg/L | |
| Blood | 0.033% | 10 mg/L | Falsely elevated by one color block |
| | | 30 mg/L | |
| Sodium phosphate | 218.75 mg/dL | 10 mg/L | Falsely elevated by one color block |
| | | 30 mg/L | |
| Sodium chloride | 1787.5 mg/dL | 30 mg/L | Falsely decreased by one color block |
| Unconjugated bilirubin | 6.38 mg/dL | 10 mg/L | Falsely elevated by one color block |
| | | 30 mg/L | Falsely decreased by one color block |
| Pastassium chloride | 656.25 mg/dL | 30 mg/L | Falsely decreased by one color block |
| Riboflavin | 6.625 mg/dL | 30 mg/L | Falsely decreased by one color block |
| Human IgG | 8.13 mg/dL | 10 mg/L | Falsely elevated by one color block |
| | | 30 mg/L | |
| pH | 10 | 30 mg/L | Falsely elevated by one color block |

Creatinine

| Interferent | Lowest Concentration Interference was Observed | Analyte Level | Affect on Results |
| --- | --- | --- | --- |
| Hemoglobin | 2.13 mg/dL | 10 mg/dL | Falsely elevated by one color block |
| | | 50 mg/dL | |
| Blood | 0.033% | 10 mg/dL | Falsely elevated by one color block |
| | | 50 mg/dL | |
| Sodium phosphate | 162.5 mg/dL | 50 mg/dL | Falsely decreased by one color block |
| | | 300 mg/dL | |
| Unconjugated bilirubin | 93.5 mg/dL | 10 mg/dL | Falsely elevated by one color block |
| | | 50 mg/dL | |

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| Interferent | Lowest Concentration Interference was Observed | Analyte Level | Affect on Results |
| --- | --- | --- | --- |
| Pastassium chloride | 825 mg/dL | 50 mg/dL | Falsely elevated by one color block |
| Sodium chloride | 1787.5 mg/dL | 10 mg/dL
50 mg/dL | Falsely elevated by one color block |
| Sodium bicarbonate | 159.38 mg/dL | 50 mg/dL
300 mg/dL | Falsely decreased by one color block |
| Calcium chloride | 120.31 mg/dL | 50 mg/dL | Falsely elevated by one color block |
| Ascorbic acid | 42.5 mg/dL | 50 mg/dL
300 mg/dL | Falsely decreased by one color block |

All urine samples evaluated by this device should be tested for blood using a urinalysis device that tests for blood. If testing indicates the presence of blood equal to or greater than 80 erythrocytes/microliter ( $\geq 2+$ ), the sample should not be tested with this assay.

Urine samples with visible levels of color interferents (e.g., riboflavin, ascorbic acid) should not be tested with the device.

## Specific gravity (SG)

Urine samples spiked with albumin (10 mg/L, 30 mg/L, 150 mg/L) or creatinine (10 mg/dL, 50 mg/dL, 300 mg/dL) were adjusted to specific gravities of 1.000, 1.005, 1.015, 1.020, 1.025, 1.030, 1.035, and 1.040. No interference from SG was detected on albumin or creatinine measurements in the examined range.

## pH

Urine samples spiked with albumin (10 mg/L, 30 mg/L, 150 mg/L) or creatinine (10 mg/dL, 50 mg/dL, 300 mg/dL) were adjusted to pH 4.0, 5.0, 6.0, 8.0, and 9.0. pH of 10 showed interference at the 30 mg/L albumin block, and generated falsely increased results of +1 block. None of the other pH levels had an interfering effect at any other concentration of albumin or creatinine.

## f. Assay cut-off:

Not applicable.

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2. Comparison studies:

a. Method comparison with predicate device:

375 male and female subjects, aged 18 – 80 years and older undergoing routine physical examinations, or with diseases such as Type 1 or Type 2 diabetes, hypertension, heart disease, kidney disease, and subjects with other ailments that represent the target population for this device were enrolled for testing at three sites. 60 spiked samples were used to supplement some analyte concentrations. All subjects provided a urine sample, which was measured with the device by one operator, and on the predicate device by a second technician. Results were consistent across the three test sites; results are summarized in the tables below.

| Candidate | Predicate | | | | |
| --- | --- | --- | --- | --- | --- |
| Albumin (mg/L) | 10 | 30 | 80 | 150 | Total count |
| 10 | 229 (92.0%) | 3 (3.7%) | 0 | 0 | 232 |
| 30 | 20 (8.0%) | 65 (80.2%) | 4 (10.0%) | 0 | 89 |
| 80 | 0 | 13 (16%) | 35 (87.5%) | 5 (7.8%) | 53 |
| 150 | 0 | 0 | 1 (2.5%) | 59 (92.2%) | 60 |
| Total count | 249 | 81 | 40 | 64 | 434 |
| % Exact Match | 92.0% | 80.2% | 87.5% | 92.2% | |
| % ± 1 color block | 100% | 100% | 100% | 100% | |

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| Candidate | Predicate | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Creatinine (mg/dL) | 10 | 50 | 100 | 200 | 300 | Total count |
| 10 | 124 (86.1%) | 0 | 0 | 0 | 0 | 124 |
| 50 | 20 (13.9%) | 82 (82.0%) | 5 (5.4%) | 0 | 0 | 107 |
| 100 | 0 | 18 (18.0%) | 77 (82.8%) | 5 (8.5%) | 0 | 100 |
| 200 | 0 | 0 | 11 (11.8%) | 48 (81.4%) | 3 (7.8%) | 62 |
| 300 | 0 | 0 | 0 | 6 (10.2%) | 35 (92.2%) | 41 |
| Total count | 144 | 100 | 93 | 59 | 38 | 440 |
| % Exact Match | 86.1% | 82.0% | 82.8% | 81.4% | 92.2% | |
| % ± 1 color block | 100% | 100% | 100% | 100% | 100% | |
| Candidate | Predicate | | | |
| --- | --- | --- | --- | --- |
| Albumin:Creatinine ratio (ACR) | Normal | Abnormal | High-Abnormal | Total count |
| Normal | 264 | 2 | 0 | 266 |
| | 92.0% | 2.1% | | |
| Abnormal | 23 | 87 | 1 | 111 |
| | 8% | 92.6% | 1.9% | |
| High-Abnormal | 0 | 5 | 52 | 57 |
| | | 5.3% | 98.1% | |
| Total count | 287 | 94 | 53 | 434 |
| % exact agreement | 92.0% | 92.6% | 98.1% | 92.86 |

b. Matrix comparison:

Not applicable. This device is for testing with human urine only.

3. Clinical studies:

a. Clinical Sensitivity:

Not applicable.

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b. Clinical specificity:

Not applicable.

c. Other clinical supportive data (when a. and b. are not applicable):

Not applicable.

4. Clinical cut-off:

Not applicable.

5. Expected values/Reference range:

The following statements regarding expected values are provided in the ACR | LAB Urine Analysis Test System user manual:

Albumin: Normally, albumin is present in urine at concentrations $< 20\mathrm{mg/L}^1$. Results of $20-200\mathrm{mg/L}$ may indicate microalbuminuria. It is associated with early-stage kidney disease when a small amount of Albumin, also called Microalbumin, is consistently present in urine. Clinical albuminuria is indicated by results of $>200\mathrm{mg/L}$. These levels can be predictive of albumin excretion rates of $30-300\mathrm{mg/24}$ hours and $>300\mathrm{mg/24}$ hours, respectively$^{2-3}$. Exercise, acute illness and fever, and urinary tract infections may temporarily elevate urinary albumin excretions.

Creatinine: Creatinine concentrations of $10-300\mathrm{mg/dL}$ are normally present in urine.

Albumin-to-Creatinine Ratio (microalbumin/Creatinine): Albumin is normally present in urine at concentrations of $< 30\mathrm{mg/g}$. Microalbuminuria is indicated at a ratio result of $30 - 300\mathrm{mg/g}$ (moderately increased) and clinical albuminuria at a ratio of $>300\mathrm{mg/g}$ (severely increased)$^{4}$.

1. Burtis C.A.; and Ashwood ER.: Tietz Textbook of Clinical Chemistry 3rd ed. Philadelphia: Saunders; 1999; pp. 483-484.
2. Mangili, R. et al.: Prevalence of Hypertension and Microalbuminuria in Adult Type 1 (Insulin-Dependent) Diabetic patients Without Renal Failure in Italy-Validation of Screening Techniques to Detect Microalbuminuria. Acta Diabetol. 29: 156-166; 1992.
3. American Diabetes Association, Clinical Practice Recommendations, Diabetes Care, Vol. 31, Suppl. 1, January 2008.
4. Position Statement: Diabetic Nephropathy. Diabetes Care 20: S24-S27; 1997.

N. Instrument Name:

iPhone 7 (iOS 12.0)

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O. System Descriptions:

1. Modes of Operation:

Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device?

Yes ☐ X or No ☐

Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission?

Yes ☐ X or No ☐

2. Software:

FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types:

Yes ☐ X or No ☐

3. Specimen Identification:

Operators manually enter the patient identification number into the device.

4. Specimen Sampling and Handling:

The test is performed by dipping the urinalysis reagent strip into a urine sample collected into a cup.

5. Calibration:

No calibration is required.

6. Quality Control:

The app has internal controls designed to account for environmental conditions that impact the accuracy of the test. The sponsor recommends testing commercially available positive and negative quality controls per the laboratory policies, in accordance with local, state, and federal regulations.

P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:

1. Carryover study: Test strips were held in both the "up" (with the creatinine on top) and

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"down" (with the albumin on top) positions for 0 (control), 15, 30, 60, 90, and 120 seconds after being dipped in solutions. The "up" experiment used a high-positive creatinine solution (300 mg/dL) and a negative albumin solution. The "down" experiment used a high-positive albumin solution (150 mg/L) with a negative creatinine solution. The experiment consisted of 240 measurements (6 timings x 2 test strips lots x 5 replicates x 2 operating systems x 2 configurations ("up" / "down") = 240 results). Though none of these configurations demonstrated any impact, labeling directs the user to place the test strips on the Color-Board after dipping it in the urine to prevent run-off from flowing from one patch into another.

2. Dipping study: Test strips were dipped in samples containing negative, low positive, and high positive concentrations (measured as 10, 30, and 150 mg/L albumin, respectively and 10, 50, and 300 mg/dL creatinine, respectively). Samples were measured for four different time durations to test the impact of various dipping times on the ACR | LAB's ability to perform accurate measurements: 1 second (control), 2 seconds, 5 seconds, and 10 seconds. Wetting time was held constant at 0 seconds and assay time was held constant at 60 seconds. The experiment consisted of 80 measurements (4 timings x 2 test strip lots x 5 replicates x 2 operating systems = 80 results). For creatinine, none of the various dipping times impacted the accuracy of the device. For albumin, at times 5- and 10-seconds there was an increase in false positive results. The user manual and in-app instructions direct the professional user to dip the ACR Reagent Strip for 1-second, and state that increasing the dipping time longer than 5 seconds can cause falsely increased results for albumin.

3. Wetting ("Blotting") study: This experiment tested different "blotting" times, i.e. the tester dipped the test strips and then waited a specific amount of time before blotting the test strips and scanning it with the ACR | LAB device. Samples containing negative, low positive, and high positive concentrations (measured as 10, 30, and 150 mg/L albumin, respectively and 10, 50, and 300 mg/dL creatinine, respectively) were measured. There were six different waiting times: 0 seconds (control), 5 seconds, 10 seconds, 20 seconds, 40 seconds, and 60 seconds. Dipping time was held constant at 1 second and assay time was held constant at 60 seconds. The experiment consisted of 60 measurements per sample (6 timings x 2 test strip lots x 5 replicates x 1 iPhone). For creatinine, none of the various dipping times impacted the accuracy of the device. For albumin, waiting 60-seconds to blot the strip resulted in false positive results. The labeling and the in-app instructions direct the user to wipe the strip on the edge of the urine cup and then immediately absorb it on a paper towel for 1 second to remove any excess urine after dipping. The labeling also includes a warning that waiting longer than 60 seconds before blotting the strip can cause falsely increased results for albumin.

4. Assay time study: This experiment tested how different assay times impact the ACR | LAB's ability to measure accurate results. Test strips were dipped and then immediately blotted, per the device's instructions. The user then waited a predetermined amount of time before scanning the test strips: 60 seconds (control), 80 seconds, 100 seconds, and 120 seconds. Dipping time was held constant at 1 second and wetting time was held constant at 0 seconds. Samples containing negative, low positive, and high positive

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concentrations (measured as 10, 30, and 150 mg/L albumin, respectively and 10, 50, and 300 mg/dL creatinine, respectively) were measured. The experiment consisted of 40 measurements per sample (4 timings x 2 test strip lots x 5 replicates x 1 iPhone). None of the assay time durations had any impact on the ACR | LAB's ability to accurately measure albumin or creatinine. Labeling and in-app instructions direct the user to wait for 60 seconds and then scan the test strip and Color-Board.

5. Illumination study: The accuracy of the subject device was tested under ten simulated lighting conditions (fluorescent 6000K, fluorescent 2700K, compact fluorescent lamp 6000K, compact fluorescent lamp 6500K, compact fluorescent lamp 2700K, LED 6000K, LED 6500K, incandescent, halogen, CW LED). Two operators used one iPhone 7 (iOS 12.0) to test 2 spiked urine samples (10 mg/L or 150 mg/L albumin and 10 mg/dL or 300 mg/dL creatinine) with 2 strip lots and 3 replicates per lot or 5 printed test strip configurations (with creatinine at 10, 50, 100, 200, and 300 mg/dL and albumin at 10, 30, 80, and 150 mg/L) at 4 replicates per lot. All results were reported as an exact match with expected results.

6. Boundary study: The accuracy of the subject device was tested under 5 boundary conditions (i.e., different distances, angles, and extreme lighting conditions). One iPhone 7 (iOS 12.0) was used to test 2 spiked urine samples (10 mg/L or 150 mg/L albumin and 10 mg/dL or 300 mg/dL creatinine) with 2 strip lots and 3 replicates per lot or 5 printed test strip configurations (with creatinine at 10, 50, 100, 200, and 300 mg/dL and albumin at 10, 30, 80, and 150 mg/L) at 5 replicates per lot. All results were reported as an exact match with expected results.

Q. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable.

R. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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