DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette

K181551 · Runbio Biotech Co.,Ltd · LCX · Feb 22, 2019 · Clinical Chemistry

Device Facts

• Record ID: K181551
• Device Name: DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette
• Applicant: Runbio Biotech Co.,Ltd
• Product Code: LCX · Clinical Chemistry
• Decision Date: Feb 22, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

DAVID One Step Home Use Pregnancy Test Strip is an in-Vitro diagnostic test device for the qualitative detection of human chorionic gonadotropin (HCG) in the urine. The test device is intended for use as an aid in early detection of pregnancy. in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period. This product is intended for over-the-counter use. DAVID One Step Home Use Pregnancy Test Cassette is an in-Vitro diagnostic test device for the qualitative detection of human chorionic gonadotropin (HCG) in the urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period. This product is intended for over-the-counter use. DAVID One Step Home Use Pregnancy Test Midstream is an in-Vitro diagnostic test device for the qualitative detection of human chorionic gonadotropin (HCG) in the urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period. This product is intended for over-the-counter use only. DAVID One Step Prescription Pregnancy Test Strip is an in-Vitro diagnostic test device for the qualitative detection of human chorionic gonadotropin (HCG) in the urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period. This product is intended for prescription use. DAVID One Step Prescription Pregnancy Test Cassette is an in-Vitro diagnostic test device for the qualitative detection of human chorionic gonadotropin (HCG) in the urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period. This product is intended for prescription use.

Device Story

Lateral flow immunoassay for qualitative hCG detection in urine; utilizes double antibody sandwich method. Mouse monoclonal anti-beta-hCG antibody-colloidal gold conjugate pre-dried on pad; mouse monoclonal anti-alpha-hCG antibody on test line; goat anti-mouse IgG on control line. Available in strip, cassette, and midstream formats. User applies urine sample; capillary action moves sample across membrane. If hCG present above 10 mIU/mL cutoff, red line appears at test line; control line confirms test validity. Used in home or clinical settings; results interpreted visually by user or healthcare provider. Provides early pregnancy detection up to 6 days before missed period. Benefits include rapid, accessible pregnancy confirmation.

Clinical Evidence

Clinical performance evaluated via 1,287 urine samples from 99 women (ages 20-40) across conception cycles (days -10 to +2 relative to expected period). Detection rates reached 100% by day 0. Lay-user study (360 participants) confirmed ease of use and interpretation. Non-pregnant urine analysis (900 samples) showed 1 false positive in post-menopausal group (>55 years). Bench testing confirmed 10 mIU/mL sensitivity and no high-dose hook effect up to 2,000,000 mIU/mL.

Technological Characteristics

Lateral flow immunochromatographic assay. Components: nitrocellulose membrane, mouse monoclonal anti-alpha-hCG (test line), goat anti-mouse IgG (control line), mouse monoclonal anti-beta-hCG colloidal gold conjugate. Formats: strip, cassette, midstream. Qualitative visual readout. Traceable to WHO 5th International Standard for hCG. No electronic components or software.

Indications for Use

Indicated for qualitative detection of human chorionic gonadotropin (hCG) in urine as an aid in early pregnancy detection. Intended for use by women of childbearing age, available for both over-the-counter and prescription use.

Regulatory Classification

Identification

A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.

Predicate Devices

• FIRST RESPONSE Early Result Pregnancy Test (k123436)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
k181551

B. Purpose for Submission:
New Device

C. Measurand:
Human chorionic gonadotropin

D. Type of Test:
Qualitative Lateral flow immunoassay.

E. Applicant:
Runbio BioTech Co., Ltd.

F. Proprietary and Established Names:
DAVID One Step Home Use Pregnancy Test Strip
DAVID One Step Home Use Pregnancy Test Cassette
DAVID One Step Home Use Pregnancy Test Midstream
DAVID One Step Prescription Pregnancy Test Strip
DAVID One Step Prescription Pregnancy Test Cassette

G. Regulatory Information:

1. Regulation section:
21 CFR 862.1155 Human Chorionic Gonadotropin (HCG) test system

2. Classification:
Class II

3. Product code:
LCX: Kit, test, pregnancy, hCG, over the counter
JHI: Visual, pregnancy hCG, prescription use

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4. Panel:

Chemistry (75)

H. Intended Use:

1. Intended use(s):

See Indications for use below.

2. Indication(s) for use:

DAVID One Step Home Use Pregnancy Test Strip is an in-Vitro diagnostic test device for the qualitative detection of human chorionic gonadotropin (HCG) in the urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.

This product is intended for over-the-counter use.

DAVID One Step Home Use Pregnancy Test Cassette is an in-Vitro diagnostic test device for the qualitative detection of human chorionic gonadotropin (HCG) in the urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.

This product is intended for over-the-counter use.

DAVID One Step Home Use Pregnancy Test Midstream is an in-Vitro diagnostic test device for the qualitative detection of human chorionic gonadotropin (HCG) in the urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.

This product is intended for over-the-counter use only.

DAVID One Step Prescription Pregnancy Test Strip is an in-Vitro diagnostic test device for the qualitative detection of human chorionic gonadotropin (HCG) in the urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.

This product is intended for prescription use.

DAVID One Step Prescription Pregnancy Test Cassette is an in-Vitro diagnostic test device for the qualitative detection of human chorionic gonadotropin (HCG) in the urine.

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The test device is intended for use as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.

This product is intended for prescription use.

3. Special conditions for use statement(s):
DAVID One Step Home Use Pregnancy Test Strip is intended for over-the-counter use.
DAVID One Step Home Use Pregnancy Test Cassette is intended for over-the-counter use.
DAVID One Step Home Use Pregnancy Test Midstream is intended for over-the-counter use.
DAVID One Step Prescription Pregnancy Test Strip is intended for prescription use.
DAVID One Step Prescription Pregnancy Test Cassette is intended for prescription use.

4. Special instrument requirements:
None

I. Device Description:

DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Home Use Pregnancy Test Cassette, DAVID One Step Prescription Pregnancy Test Cassette and DAVID One Step Home Use Pregnancy Test Midstream each contain a pouch with the device and instructions in addition the cassette and strip formats are packaged with one pipette dropper and one desiccant.

DAVID One Step Home Use Pregnancy Test Midstream consists of a single test strip encased in plastic device housing. The devices utilize a combination of antibodies to detect hCG in urine as well as to serve as a run control. Each device contains mouse monoclonal anti-β-hCG antibody colloidal gold conjugate pre-dried on a pad. Mouse monoclonal anti-α-hCG antibody (on the Test Line) and goat anti mouse IgG polyclonal antibody (on the Control Line) are coated and immobilized on a nitrocellulose membrane.

J. Substantial Equivalence Information:

1. Predicate device name(s):
FIRST RESPONSE Early Result Pregnancy Test

2. Predicate 510(k) number(s):
k123436

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3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | DAVID One Step Pregnancy Test Candidate Device (k181551) | FIRST RESPONSE Early Result Pregnancy Test Predicate Device (k123436) |
| Intended Use | Aid in early detection of pregnancy | Same |
| Early Detection claim | Detects pregnancy as early as 5 days before the expected period or as early as 6 days before the day of the missed period | Same |
| Results | Qualitative | Same |
| Test Principle | Lateral flow Sandwich Immunochromatographic Assay | Same |
| Analytical Sensitivity | 10mIU/mL | Same |
| Differences | | |
| --- | --- | --- |
| Item | DAVID One Step Pregnancy Test Candidate Device (k181551) | FIRST RESPONSE Early Result Pregnancy Test Predicate Device (k123436) |
| Device format | Strip, Cassette, Midstream | Midstream |
| Intended Use | Prescription use (strip and cassette) and OTC use (strip, cassette and midstream) | OTC Use |
| Time to Result | 5 minutes | 3 minutes |
| Traceability | World Health Organization (WHO) 5th International Standard (IS) for hCG | WHO 4th International Standard for hCG |

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

None referenced.

L. Test Principle:

DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Home Use Pregnancy Test Cassette, DAVID One Step Prescription Pregnancy Test Cassette and DAVID One Step Home Use Pregnancy Test Midstream utilize a double antibody sandwich method. During the test procedure, hCG in

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the urine specimen reacts with the dye conjugate (mouse anti- $\beta$ -hCG antibody-colloidal gold conjugate specific to the beta subunit of hCG) and forms a complex. This complex migrates by capillary action along the test strip to the $\alpha$ -hCG antibody test line; If hCG is present in the sample, the complex is captured onto the test line, where if hCG is present at concentrations above the cutoff, a red line becomes visible indicating a positive result. If hCG is not present in the sample above the cutoff, no line is visible on the test line, indicating a negative result. The control line should develop regardless of the test line result, if the test was correctly used and/or performed correctly, since mouse anti- $\beta$ -hCG antibody-colloidal gold conjugate is present in excess to bind to the antibodies at the control line, resulting in a visible red line.

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

# 1. Analytical performance:

# a. Precision/Reproducibility:

Precision study were performed for the DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, and DAVID One Step Home Use Pregnancy Test Midstream devices using 50 urine samples spiked with hCG traceable to the WHO 5th IS. The DAVID One Step Home Use Pregnancy Test Strip and the DAVID One Step Prescription Pregnancy Test Strip are identical except for the intended user, therefore the DAVID One Step Prescription Pregnancy Test Strip was used in this study. The DAVID One Step Prescription Pregnancy Test Cassette and the DAVID One Step Home Use Pregnancy Test Cassette are identical, therefore the DAVID One Step Prescription Pregnancy Test Cassette was used in this study. Samples created had concentrations of 0, 3, 6, 7.5, 9, 10, 15, 25 mIU/mL. Samples were masked and randomized prior to testing. The study was conducted in replicates of 10 for 5 days using 3 different lots of each format in 3 sites with one format per site. A total of 150 test results per lot of device for each concentration were obtained. The results for each format are summarized in the following tables

DAVID One Step Prescription Pregnancy Test Strip results

| hCG Concentration | LOT1 | LOT2 | LOT3 | % positive |
| --- | --- | --- | --- | --- |
| HCG 0mIU/mL | -/- (50/50) | -/- (50/50) | -/- (50/50) | 0% |
| HCG 3mIU/mL | -/- (50/50) | -/- (50/50) | -/- (50/50) | 0% |
| HCG 6mIU/mL | -/- (49/50) | -/- (49/50) | -/- (50/50) | 1% |
| HCG 7.5mIU/mL | +/+ (26/50) | +/+ (24/50) | +/+ (24/50) | 49% |
| HCG 9mIU/mL | +/+ (49/50) | +/+ (49/50) | +/+ (48/50) | 97% |
| HCG 10mIU/mL | +/+ (50/50) | +/+ (50/50) | +/+ (50/50) | 100% |
| HCG 15mIU/mL | +/+ (50/50) | +/+ (50/50) | +/+ (50/50) | 100% |
| HCG 25mIU/mL | +/+ (50/50) | +/+ (50/50) | +/+ (50/50) | 100% |

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DAVID One Step Prescription Pregnancy Test Cassette results

| hCG Concentration | LOT1 | LOT2 | LOT3 | % positive |
| --- | --- | --- | --- | --- |
| HCG 0mIU/mL | -/- (50/50) | -/- (50/50) | -/- (50/50) | 0% |
| HCG 3mIU/mL | -/- (50/50) | -/- (50/50) | -/- (50/50) | 0% |
| HCG 6mIU/mL | -/- (49/50) | -/- (49/50) | -/- (49/50) | 2% |
| HCG 7.5mIU/mL | +/+ (25/50) | +/+ (26/50) | +/+ (24/50) | 50% |
| HCG 9mIU/mL | +/+ (49/50) | +/+ (50/50) | +/+ (49/50) | 98% |
| HCG 10mIU/mL | +/+ (50/50) | +/+ (50/50) | +/+ (50/50) | 100% |
| HCG 15mIU/mL | +/+ (50/50) | +/+ (50/50) | +/+ (50/50) | 100% |
| HCG 25mIU/mL | +/+ (50/50) | +/+ (50/50) | +/+ (50/50) | 100% |

DAVID One Step Home Use Pregnancy Test Midstream results

| hCG Concentration | LOT1 | LOT2 | LOT3 | % positive |
| --- | --- | --- | --- | --- |
| HCG 0mIU/mL | -/- (50/50) | -/- (50/50) | -/- (50/50) | 0% |
| HCG 3mIU/mL | -/- (50/50) | -/- (50/50) | -/- (50/50) | 0% |
| HCG 6mIU/mL | -/- (50/50) | -/- (50/50) | -/- (50/50) | 0% |
| HCG 7.5mIU/mL | +/+ (24/50) | +/+ (24/50) | +/+ (24/50) | 48% |
| HCG 9mIU/mL | +/+ (47/50) | +/+ (48/50) | +/+ (47/50) | 95% |
| HCG 10mIU/mL | +/+ (50/50) | +/+ (50/50) | +/+ (50/50) | 100% |
| HCG 15mIU/mL | +/+ (50/50) | +/+ (50/50) | +/+ (50/50) | 100% |
| HCG 25mIU/mL | +/+ (50/50) | +/+ (50/50) | +/+ (50/50) | 100% |

b. Linearity/assay reportable range:
Not applicable. The device provides qualitative results only.

c. Traceability, Stability, Expected values (controls, calibrators, or methods):
DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Home Use Pregnancy Test Cassette, DAVID One Step Prescription Pregnancy Test Cassette and DAVID One Step Home Use Pregnancy Test Midstream devices are traceable to the WHO 5th reference material.

d. Detection limit:
An analytical sensitivity/cutoff study was performed using DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Home Use Pregnancy Test Cassette and DAVID One Step Home Use Pregnancy Test Midstream. The DAVID One Step

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Home Use Pregnancy Test Strip and the DAVID One Step Prescription Pregnancy Test Strip are identical except for intended user, therefore DAVID One Step Home Use Pregnancy Test Strip was used in this study. The DAVID One Step Home Use Pregnancy Test Cassette and the DAVID One Step Prescription Pregnancy Test Cassette are identical except for the intended user, therefore DAVID One Step Home Use Pregnancy Test Cassette was used in this study. Testing was performed using negative native human urine samples with hCG traceable to the WHO $5^{\text{th}}$ IS for hCG to obtain concentrations of 0, 3, 5, 6, 7.5, 9, 10, 13, 15, 25 mIU/mL of hCG. The samples were measured using 3 formats strip, cassette and midstream. The samples were tested in 10 replicates, using 3 lots of reagents of each format. The tests were performed by 12 different operators for 3 days. A different set of operators tested each format of the device. The obtained results are summarized in the following tables.

DAVID One Step Home Use Pregnancy Test Strip results

| HCG concentration | LOT1 | LOT2 | LOT2 | % positive |
| --- | --- | --- | --- | --- |
| HCG0mIU/mL | +/+(0/30) | +/+(0/30) | +/+(0/30) | 0% |
| HCG3mIU/mL | +/+(0/30) | +/+(0/30) | +/+(1/30) | 1% |
| HCG5mIU/mL | +/+(1/30) | +/+(0/30) | +/+(0/30) | 1% |
| HCG 6mIU/mL | +/+1/30) | +/+(2/30) | +/+(1/30) | 3% |
| HCG 7.5mIU/mL | +/+(15/30) | +/+(15/30) | +/+(14/30) | 48% |
| HCG 9mIU/mL | +/+(30/30) | +/+(29/30) | +/+(29/30) | 98% |
| HCG 10mIU/mL | +/+(30/30) | +/+(30/30) | +/+(30/30) | 100% |
| HCG 13mIU/mL | +/+(30/30) | +/+(30/30) | +/+(30/30) | 100% |
| HCG 15mIU/mL | +/+(30/30) | +/+(30/30) | +/+(30/30) | 100% |
| HCG 25mIU/mL | +/+(30/30) | +/+(30/30) | +/+(30/30) | 100% |

DAVID One Step Home Use Pregnancy Test Cassette results

| HCG concentration | LOT1 | LOT2 | LOT2 | % positive |
| --- | --- | --- | --- | --- |
| HCG0mIU/mL | +/+(0/30) | +/+(0/30) | +/+(0/30) | 0% |
| HCG3mIU/mL | +/+(0/30) | +/+(1/30) | +/+(0/30) | 1% |
| HCG5mIU/mL | +/+(1/30) | +/+(0/30) | +/+(0/30) | 2% |
| HCG 6mIU/mL | +/+(2/30) | +/+(1/30) | +/+(1/30) | 4% |
| HCG 7.5mIU/mL | +/+(15/30) | +/+(14/30) | +/+(16/30) | 50% |
| HCG 9mIU/mL | +/+(29/30) | +/+(30/30) | +/+(30/30) | 99% |
| HCG 10mIU/mL | +/+(30/30) | +/+(30/30) | +/+(30/30) | 100% |
| HCG 13mIU/mL | +/+(30/30) | +/+(30/30) | +/+(30/30) | 100% |

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| HCG concentration | LOT1 | LOT2 | LOT2 | % positive |
| --- | --- | --- | --- | --- |
| HCG 15mIU/mL | +/+(30/30) | +/+(30/30) | +/+(30/30) | 100% |
| HCG 25mIU/mL | +/+(30/30) | +/+(30/30) | +/+(30/30) | 100% |

DAVID One Step Home Use Pregnancy Test Midstream dip method results

| HCG concentration | LOT1 | LOT2 | LOT2 | % positive |
| --- | --- | --- | --- | --- |
| HCG0mIU/mL | +/+(0/30) | +/+(0/30) | +/+(0/30) | 0% |
| HCG3mIU/mL | +/+(0/30) | +/+(0/30) | +/+(0/30) | 0% |
| HCG5mIU/mL | +/+(0/30) | +/+(1/30) | +/+(1/30) | 2% |
| HCG 6mIU/mL | +/+(2/30) | +/+(1/30) | +/+(1/30) | 4% |
| HCG 7.5mIU/mL | +/+(14/30) | +/+(15/30) | +/+(14/30) | 48% |
| HCG 9mIU/mL | +/+(30/30) | +/+(29/30) | +/+(30/30) | 99% |
| HCG 10mIU/mL | +/+(30/30) | +/+(30/30) | +/+(30/30) | 100% |
| HCG 13mIU/mL | +/+(30/30) | +/+(30/30) | +/+(30/30) | 100% |
| HCG 15mIU/mL | +/+(30/30) | +/+(30/30) | +/+(30/30) | 100% |
| HCG 25mIU/mL | +/+(30/30) | +/+(30/30) | +/+(30/30) | 100% |

DAVID One Step Home Use Pregnancy Test Midstream simulated stream method results

| HCG concentration | LOT1 | LOT2 | LOT2 | % positive |
| --- | --- | --- | --- | --- |
| HCG0mIU/mL | +/+(0/30) | +/+(0/30) | +/+(0/30) | 0% |
| HCG3mIU/mL | +/+(0/30) | +/+(0/30) | +/+(130) | 1% |
| HCG5mIU/mL | +/+(1/30) | +/+(1/30) | +/+(1/30) | 3% |
| HCG 6mIU/mL | +/+(2/30) | +/+(1/30) | +/+(2/30) | 6% |
| HCG 7.5mIU/mL | +/+(14/30) | +/+(14/30) | +/+(14/30) | 46% |
| HCG 9mIU/mL | +/+(30/30) | +/+(29/30) | +/+(30/30) | 99% |
| HCG 10mIU/mL | +/+(30/30) | +/+(30/30) | +/+(30/30) | 100% |
| HCG 13mIU/mL | +/+(30/30) | +/+(30/30) | +/+(30/30) | 100% |
| HCG 15mIU/mL | +/+(30/30) | +/+(30/30) | +/+(30/30) | 100% |
| HCG 25mIU/mL | +/+(30/30) | +/+(30/30) | +/+(30/30) | 100% |

# e. Analytical specificity:

For all analytical specificity testing, the DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette and DAVID One Step Home Use Pregnancy Test Midstream devices were evaluated. 3 lots of each device

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format were used in all studies. The DAVID One Step Home Use Pregnancy Test Strip and the DAVID One Step Prescription Pregnancy Test Strip are identical except for the intended user, therefore the DAVID One Step Home Use Pregnancy Test Strip was used in this study. The DAVID One Step Prescription Pregnancy Test Cassette and the DAVID One Step Home Use Pregnancy Test Cassette are identical, therefore the DAVID One Step Prescription Pregnancy Test Cassette was used in this study. Results from the three formats were the same for all analytical specificity studies, therefore results presented below apply to all formats.

# Interference study:

To evaluate potential interference from certain exogenous and endogenous compounds, and potential interfering clinical conditions, were tested using

Testing was performed using two urine samples with concentrations of 0 and 10 mIU/mL. These two samples were spiked with each of the known interferents to obtain the desired test concentration. Three different lots of each device format were tested. The results demonstrated that no interferences were observed from substances at the following concentrations for both negative and positive hCG urine samples.

| Substance Tested | Highest Concentration tested that demonstrated no interference |
| --- | --- |
| Acetaminophen | 200 μg/mL |
| Atropine | 200 μg/mL |
| Aspirin | 200 μg/mL |
| Ascorbic Acid | 200 μg/mL |
| Ampicillin | 200 μg/mL |
| Vitamins C | 200 μg/mL |
| Caffeine | 200 μg/mL |
| Gentisic Acid | 200 μg/mL |
| Ethanol | 1% |
| Glucose | 20mg/mL |
| Albumin | 20mg/mL |
| Ephedrine | 200 μg/mL |
| Thiophene | 200 μg/mL |
| Phenylpropanolamine | 200 μg/mL |
| Ephidine | 200 μg/mL |
| Acetylsalicylic Acid | 200 μg/mL |
| Salicyclic Acid | 200 μg/mL |

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| Substance Tested | Highest Concentration tested that demonstrated no interference |
| --- | --- |
| Phenothiazine | 200 μg/mL |
| Tetracycline | 200 μg/mL |
| estriol | 10 μg/ /mL |
| Bilirubin | 20μg/mL |
| Hemoglobin | 10 μg/mL |

## Effects of hCG β-core Fragment:

To evaluate potential interference by hCG β-core fragment, a negative urine sample and a urine sample with 10 mIU/mL were spiked with hCG beta core fragment (traceable to WHO reference reagent 99/708) to yield samples with concentrations of (62,500, 125,000, 250,000, 500,000, and 1,000,000 pmol/L. These samples were tested with 3 lots of each device. The data obtained demonstrated that there is no interference by hCG β-core fragment at the concentrations tested.

## Cross reactivity of similar compounds:

To evaluate cross-reactivity, hCG negative urine and hCG positive urine containing 10 mIU/mL hCG were spiked with various concentrations of glycoprotein hormones: Luteinizing Hormone (LH), Follicle stimulating Hormone (FSH), and thyroid stimulating hormone (TSH). These samples were tested using 3 lots of each device. The results demonstrated there is no interference from the tested glycoprotein hormones up to 500 mIU/mL LH, 1000 mIU/mL FSH, and 1000 μIU/mL TSH in either negative or positive urine samples

## pH Interference Study:

To evaluate potential interference from changes in urine pH, urine samples containing 0 mIU/mL 10 mIU/mL were tested with 3 lots of each device using samples at pH 4, 5, 6, 7, 8, and 9. The results demonstrated that samples within the pH range of 4-9 do not interfere with either positive or negative results from the device.

## Specific Gravity Interference study:

To evaluate potential interference from changes in specific gravity, testing was performed with urine samples containing 0 mIU/mL and 10 mIU/mL hCG were adjusted to specific gravities spanning the physiological range and tested with 3 lots of each device. The results indicate that changes in specific gravity do not interfere with either positive or negative results from the device

## High dose hook effect study:

To evaluate the high dose hook effect, testing was performed with hCG free urine sample was spiked with varying hCG concentration of ranging from 50 mIU/mL to 2,000,000 mIU/mL. These samples were tested using 3 lots of each device. The result show that there is no hook effect observed at the concentrations tested.

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f. Assay cut-off:

See Section M.1.a., above.

## 2. Comparison studies:

a. Method comparison with predicate device:

A method comparison study was performed with the DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Home Use Pregnancy Test Cassette, and DAVID One Step Home Use Pregnancy Test Midstream devices. The DAVID One Step Home Use Pregnancy Test Strip and the DAVID One Step Prescription Pregnancy Test Strip are identical except for the intended user, therefore the DAVID One Step Home Use Pregnancy Test Strip was used in this study. The DAVID One Step Prescription Pregnancy Test Cassette and the DAVID One Step Home Use Pregnancy Test Cassette are identical, therefore the DAVID One Step Home Use Pregnancy Test Cassette was used in this study.

Testing was performed at 3 hospital sites with 120 urine samples in each of the sites for a total of 360 samples from women of child bearing age (age range 18-45), who were suspecting pregnancy. Samples were randomly collected at various times throughout the day and were masked and randomized prior to testing. Results of the professional using the candidate device were compared to results obtained from the predicate device. Summary of results is presented in the table below:

DAVID One Step Home Use Pregnancy Test Strip results

| | Predicate device professional | | |
| --- | --- | --- | --- |
| | | Positive | Negative |
| Candidate device | Positive | 52 | 0 |
| | Negative | 0 | 68 |

DAVID One Step Home Use Pregnancy Test Cassette results

| | Predicate device professional | | |
| --- | --- | --- | --- |
| | | Positive | Negative |
| Candidate device | Positive | 64 | 0 |
| | Negative | 0 | 56 |

DAVID One Step Home Use Pregnancy Test Midstream dip method results

| | Predicate device professional | | |
| --- | --- | --- | --- |
| | | Positive | Negative |
| Candidate device | Positive | 73 | 0 |
| | Negative | 0 | 47 |

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DAVID One Step Home Use Pregnancy Test Midstream results (simulated method)

| | Predicate device professional | | |
| --- | --- | --- | --- |
| | | Positive | Negative |
| Candidate device | Positive | 73 | 0 |
| | Negative | 0 | 47 |

b. Matrix comparison:
Not applicable.

3. Clinical studies:

a. Clinical Sensitivity:
Not Applicable.

b. Clinical specificity:
Not Applicable.

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

A total of 1287 urine samples were collected from 99 different women (21-40 years old) who planned to become pregnant. These women were followed throughout their conception cycles with urine collected from approximately day -10 to day 2, based on their estimated expected period date. Testing was performed using DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Home Use Pregnancy Test Cassette and DAVID One Step Home Use Pregnancy Test Midstream devices. The DAVID One Step Home Use Pregnancy Test Strip and the DAVID One Step Prescription Pregnancy Test Strip are identical except for the intended user, therefore the DAVID One Step Home Use Pregnancy Test Strip was used in this study. The DAVID One Step Prescription Pregnancy Test Cassette and the DAVID One Step Home Use Pregnancy Test Cassette are identical, therefore the DAVID One Step Home Use Pregnancy Test Cassette was used in this study

All samples were masked and randomized then tested by laboratory technicians in all 3 formats with one lot of (strip format, cassette format, midstream format both dip and stream methods). The results are summarized in the following table for women who successfully conceived.

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DAVID One Step Home Use Pregnancy Test Strip results

| Day relative to EMP | EMP +2 | EMP +1 | EMP -0 | EMP -1 | EMP -2 | EMP -3 | EMP -4 | EMP -5 | EMP -6 | EMP -7 | EMP -8 | EMP -9 | EMP -10 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| # of cycles positive for hCG | 99 | 99 | 99 | 99 | 98 | 98 | 95 | 77 | 38 | 17 | 7 | 3 | 0 |
| # of cycles negative for hCG | 0 | 0 | 0 | 0 | 1 | 1 | 4 | 22 | 61 | 82 | 92 | 96 | 99 |
| % cycles positive for hCG | 100% | 100% | 100% | 100% | 99% | 99% | 96% | 77% | 38% | 17% | 7% | 3% | 0% |

DAVID One Step Home Use Pregnancy Test Cassette results

| Day relative to EMP | EMP +2 | EMP +1 | EMP -0 | EMP -1 | EMP -2 | EMP -3 | EMP 4 | EMP -5 | EMP -6 | EMP -7 | EMP -8 | EMP -9 | EMP -10 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| # of cycles positive for hCG | 99 | 99 | 99 | 99 | 99 | 97 | 95 | 76 | 37 | 17 | 8 | 3 | 0 |
| # of cycles negative for hCG | 0 | 0 | 0 | 0 | 0 | 2 | 4 | 23 | 62 | 82 | 91 | 96 | 99 |
| % cycles positive for hCG | 100% | 100% | 100% | 100% | 100% | 98% | 97% | 77% | 37% | 17% | 9% | 3% | 0% |

DAVID One Step Home Use Pregnancy Test Midstream dip method results

| Day relative to EMP | EMP +2 | EMP +1 | EMP -0 | EMP -1 | EMP -2 | EMP -3 | EMP -4 | EMP -5 | EMP -6 | EMP -7 | EMP -8 | EMP -9 | EMP -10 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| # of cycles positive for hCG | 99 | 99 | 99 | 99 | 98 | 98 | 96 | 76 | 38 | 18 | 7 | 3 | 0 |
| # of cycles negative for hCG | 0 | 0 | 0 | 0 | 1 | 1 | 3 | 23 | 61 | 81 | 92 | 96 | 99 |
| % cycles positive for hCG | 100% | 100% | 100% | 100% | 99% | 99% | 97% | 77% | 38% | 18% | 7% | 3% | 0% |

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DAVID One Step Home Use Pregnancy Test Midstream results (simulated stream method)

| Day relative to EMP | EMP +2 | EMP +1 | EMP -0 | EMP -1 | EMP -2 | EMP -3 | EMP -4 | EMP -5 | EMP -6 | EMP -7 | EMP -8 | EMP -9 | EMP -10 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| # of cycles positive for hCG | 99 | 99 | 99 | 99 | 90 | 99 | 96 | 80 | 39 | 18 | 9 | 4 | 1 |
| # of cycles negative for hCG | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 19 | 60 | 80 | 91 | 95 | 98 |
| % cycles positive for hCG | 100% | 100% | 100% | 100% | 100% | 100% | 97% | 80% | 39% | 19% | 9% | 4% | 1% |

## Lay-user study:

The sponsor performed two studies with lay users.

The first study was conducted in 3 sites with 360 volunteers, 120 study subjects per site using DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Home Use Pregnancy Test Cassette and DAVID One Step Home Use Pregnancy Test Midstream devices were used in the study. The DAVID One Step Home Use Pregnancy Test Strip and the DAVID One Step Prescription Pregnancy Test Strip are identical except for the intended user, therefore the DAVID One Step Home Use Pregnancy Test Strip was used in this study. The DAVID One Step Prescription Pregnancy Test Cassette and the DAVID One Step Home Use Pregnancy Test Cassette are identical, therefore the DAVID One Step Home Use Pregnancy Test Cassette was used in this study

Study subjects were aged 20-40 years. Each subject tested their own urine on the candidate device following instructions on the package insert. The same sample was tested by a healthcare professional using the candidate devices. All samples were masked and randomized prior to professional testing. This included 120 lay users using test strip, 120 using test cassette, 120 using actual midstream method and the dip method respectively.

Summary of results for the comparison between the lay user testing with the candidate device versus the professional testing using the candidate device are presented the table below. Lay user results with the candidate device versus professional results using the predicate device are not shown, but were identical to those shown below

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DAVID One Step Home Use Pregnancy Test Strip results

| | Professionals | | |
| --- | --- | --- | --- |
| | | Positive | Negative |
| Lay user | Positive | 50 | 0 |
| | Negative | 0 | 70 |

DAVID One Step Home Use Pregnancy Test Cassette results

| | Professional | | |
| --- | --- | --- | --- |
| | | Positive | Negative |
| Lay user | Positive | 50 | 0 |
| | Negative | 0 | 70 |

DAVID One Step Home Use Pregnancy Test Midstream results

| | Professionals | | |
| --- | --- | --- | --- |
| | | Positive | Negative |
| Lay user | Positive | 50 | 0 |
| | Negative | 0 | 70 |

DAVID One Step Home Use Pregnancy Test Midstream results

(lay user using the actual midstream method and professional using the simulated midstream method)

| | Professional | | |
| --- | --- | --- | --- |
| | | Positive | Negative |
| Lay user | Positive | 50 | 0 |
| | Negative | 0 | 70 |

Lay users also completed a user survey, and the results supported that lay users believed that the device was easy to use.

A second lay-user study with an additional 120 volunteers at each site tested 4 samples using DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Home Use Pregnancy Test Cassette and DAVID One Step Home Use Pregnancy Test Midstream devices were used in this study. The DAVID One Step Home Use Pregnancy Test Strip and the DAVID One Step Prescription Pregnancy Test Strip are identical except for the intended user, therefore the DAVID One Step Home Use Pregnancy Test Strip was used in this study. The DAVID One Step Prescription Pregnancy Test Cassette and the DAVID One Step Home Use Pregnancy Test

15

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Cassette are identical, therefore the DAVID One Step Home Use Pregnancy Test Cassette was used in this study.

Testing was performed using samples with concentrations of hCG around the device cutoff (5.0, 8, 10, 11.5 mIU/mL). The testing was performed at 3 sites with one lot of each of the three test formats in each site. The midstream format was used for detection in the dip method and the simulated stream method. The results are summarized in the tables below:

DAVID One Step Home Use Pregnancy Test Strip results

| Concentration | Lay user Results | | %positive |
| --- | --- | --- | --- |
| | Number of positives | Number of Negatives | |
| HCG 5mIU/mL | 2 | 118 | 2% |
| HCG 8mIU/mL | 52 | 68 | 43% |
| HCG 10mIU/mL | 120 | 0 | 100% |
| HCG 11.5mIU/mL | 120 | 0 | 100% |

DAVID One Step Home Use Pregnancy Test Cassette results

| Concentration | Lay user Results | | %positive |
| --- | --- | --- | --- |
| | Number of positives | Number of Negatives | |
| HCG 5mIU/mL | 1 | 119 | 1% |
| HCG 8mIU/mL | 55 | 65 | 46% |
| HCG 10mIU/mL | 120 | 0 | 100% |
| HCG 11.5mIU/mL | 120 | 0 | 100% |

DAVID One Step Home Use Pregnancy Test Midstream results

| Concentration | Lay user Results | | %positive |
| --- | --- | --- | --- |
| | Number of positives | Number of Negatives | |
| HCG 5mIU/mL | 1 | 119 | 1% |
| HCG 8mIU/mL | 55 | 65 | 46% |
| HCG 10mIU/mL | 120 | 0 | 100% |
| HCG 11.5mIU/mL | 120 | 0 | 100% |

A Flesch-Kincaid reading analysis was performed on each package inserts and the score demonstrates a reading Grade Level of 8. The results of the questionnaire reflect that the consumers found the device easy to use and follow and that they did not have trouble understanding the labeling or interpreting results.

## Study to Determine false-positive result rate:

A study was conducted at three sites using DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette and DAVID One

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Step Home Use Pregnancy Test Midstream devices were used in the study. The DAVID One Step Home Use Pregnancy Test Strip and the DAVID One Step Prescription Pregnancy Test Strip are identical except for the intended user, therefore the DAVID One Step Prescription Pregnancy Test Strip was used in this study. The DAVID One Step Prescription Pregnancy Test Cassette and the DAVID One Step Home Use Pregnancy Test Cassette are identical, therefore the DAVID One Step Prescription Pregnancy Test Cassette was used in this study

Testing was performed to determine the false positive rate of the device in 300 women: 100 pre-menopausal women (18-40 years), 100 peri-menopausal group (41-55 years) and 100 post-menopausal group (>55 years old). All samples were tested by a professional with 3 lot of devices in only one format for each site. Women with positive results were confirmed not pregnant. The results are summarized in the tables below:

DAVID One Step Prescription Pregnancy Test Strip results

| Age Group | Lot I | Lot II | Lot III |
| --- | --- | --- | --- |
| Pre-menopausal (18-40 years) | 0+/100- | 0+/100- | 0+/100- |
| Peri-menopausal (41-51 years) | 0+/100- | 0+/100- | 0+/100- |
| Post-menopausal (>55 years) | 0+/100- | 0+/100- | 0+/100- |

DAVID One Step Prescription Pregnancy Test Cassette results

| Age Group | Lot I | Lot II* | Lot III |
| --- | --- | --- | --- |
| Pre-menopausal (18-40 years) | 0+/100- | 0+/100- | 0+/100- |
| Peri-menopausal (41-51 years) | 0+/100- | 0+/100- | 0+/100- |
| Post-menopausal (>55 years) | 0+/100- | 1+/100- | 0+/100- |

*The positive sample was confirmed to be positive by the predicate but negative with the ultrasound.

DAVID One Step Home Use Pregnancy Test Midstream dip method results

| Age Group | Lot I | Lot II | Lot III |
| --- | --- | --- | --- |
| Pre-menopausal (18-40 years) | 0+/100- | 0+/100- | 0+/100- |
| Peri-menopausal (41-51 years) | 0+/100- | 0+/100- | 0+/100- |
| Post-menopausal (>55 years) | 0+/100- | 0+/100- | 0+/100- |

4. Clinical cut-off:

Not Applicable.

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5. Expected values/Reference range:

Not Applicable.

N. Proposed Labeling:

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

O. Conclusion:

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

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