DAVID PREGNANCY TEST (MIDSTREAM)

K053236 · Runbio Biotech Co.,Ltd · LCX · Jul 18, 2006 · Clinical Chemistry

Device Facts

• Record ID: K053236
• Device Name: DAVID PREGNANCY TEST (MIDSTREAM)
• Applicant: Runbio Biotech Co.,Ltd
• Product Code: LCX · Clinical Chemistry
• Decision Date: Jul 18, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Indications for Use

David Pregnancy Test is a self-testing immunoassay designed for the qualitative determination of human chorionic gonadotropin (hCG) in the urine to aid in early detection of pregnancy. It is for over-the-counter use.

Device Story

David Pregnancy Test is a lateral flow immunoassay for qualitative detection of hCG in urine. Device formats include test strips and midstream devices. User collects urine sample; applies to test device; hCG, if present, binds to labeled antibodies; results appear as visual color bands on test membrane. Intended for home use by lay individuals for early pregnancy detection. Results interpreted visually by user based on presence or absence of test line relative to control line. Provides rapid qualitative assessment to aid in pregnancy confirmation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Lateral flow immunochromatographic assay. Qualitative detection of hCG in urine. Formats: test strip and midstream device. Visual readout via colorimetric antibody-antigen binding. Non-electronic, standalone diagnostic test.

Indications for Use

Indicated for qualitative detection of hCG in urine to aid in early pregnancy detection; for over-the-counter self-testing use by women.

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.

Submission Summary (Full Text)

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

A. 510(k) Number:
k053236

B. Purpose for Submission:
New device

C. Measurand:
Human chorionic gonadotropin (hCG)

D. Type of Test:
Qualitative

E. Applicant:
Runbio Biotech Co., Ltd.

F. Proprietary and Established Names:
David Pregnancy Test (Strip and Midstream)

G. Regulatory Information:
1. Regulation section:
21 CFR 862.1155
2. Classification:
Class II
3. Product code:
LCX
4. Panel:
Chemistry (75)

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H. Intended Use:

1. Intended use(s):

David Pregnancy Test is a self-testing immunoassay designed for the qualitative determination of human chorionic gonadotropin (hCG) in the urine to aid in early detection of pregnancy. It is for over-the-counter use.

2. Indication(s) for use:

David Pregnancy Test is a self-testing immunoassay designed for the qualitative determination of human chorionic gonadotropin (hCG) in the urine to aid in early detection of pregnancy. It is for over-the-counter use.

3. Special conditions for use statement(s):

This device is for over-the-counter use.

4. Special instrument requirements:

None required

I. Device Description:

The product is supplied in two formats (strip and midstream), and is composed of the following: α-hCG monoclonal antibody and anti-mouse IgG labeled nitrocellulose membrane, and colloidal gold labeled anti β-hCG monoclonal antibody.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Acon Midstream Pregnancy Test and Acon Quick-Test Strip

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

k983090 and k033041

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicates |
| Intended Use / Indications for Use | Qualitative detection of hCG in urine for early detection of pregnancy; for OTC use | Same |

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| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicates |
| Test Principle | Chromatographic immunoassay | Same |
| Sensitivity | 25 mIU/mL | Same |
| Standardization | W.H.O. 3rd I.S. | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate 2 |
| Label | Colloidal gold | Streptavidin-biotin |

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

The test has been standardized to the W.H.O. Third International Standard.

# L. Test Principle:

The test is a two-site, sandwich immunoassay.

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

# 1. Analytical performance:

# a. Precision/Reproducibility:

hCG standard solution was added to normal male urine and prepared to different concentrations: $0\mathrm{mIU / mL}$ , $12.5\mathrm{mIU / mL}$ (50% below cutoff level), $25\mathrm{mIU / mL}$ (cutoff level), $37.5\mathrm{mIU / mL}$ (50% above cutoff level), and $50\mathrm{mIU / mL}$ (100% above cutoff level). Each concentration level was tested four times daily, in duplicate, for five consecutive days. A total of 40 samples at each concentration were tested. All samples at $12.5\mathrm{mIU / mL}$ hCG and below were negative, and all samples at $25\mathrm{mIU / mL}$ hCG and above were positive.

hCG standard solution was added to normal male urine and prepared to different concentrations: $0\mathrm{mIU / mL}$ , $12.5\mathrm{mIU / mL}$ (50% below cutoff level), $25\mathrm{mIU / mL}$ (cutoff level), $37.5\mathrm{mIU / mL}$ (50% above cutoff level), and $50\mathrm{mIU / mL}$ (100% above cutoff level). Each specimen at each concentration level was tested four times daily, in duplicate, on three different lots of strips. A total of 120 samples were tested. All samples at $12.5\mathrm{mIU / mL}$ hCG and below were negative, and all samples at $25\mathrm{mIU / mL}$ hCG and above were positive. The results showed 100% agreement across the three lots.

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b. Linearity/assay reportable range:

Not applicable

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

The test has been standardized to the W.H.O. Third International Standard.

d. Detection limit:

The sensitivity claim of the test is 25 mIU/mL.

hCG standard solution was added to normal male urine and prepared to different concentrations: 0 mIU/mL, 10 mIU/mL, 25 mIU/mL, 50 mIU/mL, and 100 mIU/mL. Each concentration level was run on five test strip lots. All samples at 25 mIU/mL hCG and above were positive, and all samples at 10 mIU/mL hCG and below were negative.

e. Analytical specificity:

A male urine specimen was spiked with different concentrations of follicle stimulating hormone (FSH), luteinizing hormone (LH) and thyroid stimulating hormone (TSH) and tested on the David Pregnancy Test. Then the samples were spiked with hCG to 25 mIU/mL and tested on the David Pregnancy Test. No interference was observed with FSH up to 1000 mIU/mL, LH up to 300 mIU/mL, and TSH up to 1000 µIU/mL. All negative samples gave negative results, and all 25 mIU/mL samples gave positive results.

The David Pregnancy Test was also tested for potential interference from prescription/OTC drugs, various urinary analytes, and pH. The substances were spiked into hCG negative and hCG positive specimens. No interference was observed with the various substances at the concentrations tested. All samples yielded the expected results.

To evaluate the effect of pH, acid or base was added to urine samples containing hCG at concentrations of 0, 25, 50, 100, 200, and 5000 mIU/mL. All samples were adjusted to different pH values ranging from 3.0 to 13.0 and tested using the David Pregnancy Test. For pH values of 3.5 to 12.0, all 0 mIU/mL samples were negative and all samples ≥ 25 mIU/mL were positive.

The effect of pH using clinical samples was also evaluated. Urine samples from ten healthy, non-pregnant women and ten pregnant women were adjusted to pH ranges of 2.0 to 13 and tested. Ten negative and positive clinical samples, serving as controls, were unadjusted and also tested. All unadjusted clinical samples (both positive and negative) produced the expected results. All negative and positive samples in the pH range of 3.5 to

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12 yielded the expected results.

f. Assay cut-off:

See Detection limit above.

2. Comparison studies:

a. Method comparison with predicate device:

The David Pregnancy Test was compared to a commercially available assay using random urine specimens, collected at various times throughout the day. A total of 99 patient samples were collected, and results were available for 98 samples. The results showed 100% agreement with the commercially available assay and included 44 positives and 54 negatives.

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):

The David Pregnancy Test was analyzed with randomly selected patients' urine samples from emergency and out-patient departments. The study was conducted at two hospitals and included over 2000 samples.

In the first study which used 104 samples from women aged 21 to 40 years, 79 were positive and 25 were negative on the David Pregnancy Test. There were no false positive or false negative results. The test was in 100% agreement with the clinical diagnosis.

In the second study, 1936 samples were collected. Thirteen (13) samples were discarded because the women had been taking fertility drugs containing hCG. Of the remaining 1923 tested on the David Pregnancy Test, 1411 were negative and 512 were positive, with three being weak positives. The results agreed with the clinical diagnosis with the exception of one false negative and

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one false positive, demonstrating greater than 99% accuracy.

A study was conducted to evaluate laypersons' ability to understand the instructions and to perform the test correctly. Ninety (90) volunteers, women 20-40 years old without professional knowledge of rapid pregnancy tests and of various educational backgrounds, participated in the study. The women were randomly divided into groups and asked to perform one of the test formats according to the package insert instructions, using coded standard solutions with hCG concentrations of 10, 25, 50, and 100 mIU/mL. After testing, each woman was asked to complete a questionnaire. The test results were as follows: 89/90 10 mIU/mL results were negative, 89/90 25 mIU/mL results were positive, and all of the 50 mIU/mL and 100 mIU/mL results were positive. All of the participants felt the test procedure and reading the results were easy to understand. Ninety-nine percent (99%) of the women said the test was easy to perform following the instructions for use, and 98% said they were able to read the result without difficulty.

4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
The expected values have been established in the literature.

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

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

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