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 Description

DAVID One Step Pregnancy Test is designed in three formats: strip, cassette, and midstream. Each of the devices (strip, cassette and midstream) contains a pouch with the test device and instructions for use, additional test cassette also contains a disposable plastic dropper. The test cassette and test midstream consist of a chromatographic test strip enclosed in plastic housing. The test strip contains mouse monoclonal anti-ß-hCG antibody, mouse monoclonal anti-a-hCG antibody, goat anti-mouse IgG polyclonal antibody and colloidal gold.

The added plastic housing does not affect the performance of the product, which is determined by the test strip. The only difference between the different formats is test procedure.

The test uses two lines to indicate results. The appearance of two color bands, one at the "Test line" and one at the "Control line" region means the test is "positive". The appearance of a color band at the "Control line" region but not at the "Test line" region means the test is "negative". If there are no colored bands in the "Control line" area and "Test line" region or if there is no color band in "Control line" region even there is a band in the "Test line" region; this means "invalid" test result.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the studies performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a formal table with pass/fail metrics. However, based on the performance data presented, the implicit acceptance criteria for a qualitative pregnancy test device would be high accuracy, analytical sensitivity, and no significant interference. The reported performance is summarized below:

Criteria/Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance
Analytical Sensitivity (Lowest concentration for 100% positive)	Achieve 100% positive results at 10 mIU/mL and 50% positive at 7.5 mIU/mL.	Strips, Cassettes, Midstreams (all methods): 100% positive at 10 mIU/mL, ~48-50% positive at 7.5 mIU/mL (across 3 lots and different operators/methods).
Specificity (Cross-reactivity)	No cross-reactivity with LH (500mIU/mL), FSH (1000mIU/mL), and TSH (1000μIU/mL).	No cross-reaction observed with LH at 500mIU/mL, FSH at 1000mIU/mL, and TSH at 1000μIU/mL.
Specificity (Interference from common substances)	No interference from specified endogenous and exogenous compounds at relevant concentrations.	No interference observed from various compounds including Glucose, Albumin, Hemoglobin, Bilirubin, Estriol, common birth control pills, progestational drugs, prescription/OTC substances (Acetaminophen, Aspirin, Caffeine, etc.), antibiotics (Amikacin, Penicillin G, etc.) at specified concentrations.
Specificity (pH Effects)	No interference across a physiological urine pH range.	No interference observed with urine pH ranging from 4 to 9.
Specificity (Specific Gravity Effects)	No interference across a physiological urine specific gravity range.	No interference observed with urine specific gravity ranging from 1.000 to 1.050.
High Dose Hook Effect	No hook effect up to a very high hCG concentration.	No hook effect observed up to 2,000,000 mIU/mL hCG.
Interference from hCG ß-core Fragment	Limited or no interference from hCG ß-core fragment.	Interference demonstrated at concentrations of 1,000,000 pmol/L.
Method Comparison with Predicate Device	High agreement with the predicate device.	100% agreement (Positive: 52-73, Negative: 47-68) with the predicate device for all formats.
Clinical Sensitivity in Early Pregnancy	High detection rate on or after the expected period, and acceptable detection rate in early days before the expected period.	Strips: 100% from EMP to EMP+2, declining to 0% at EMP-10. Cassettes: 100% from EMP-2 to EMP+2, declining to 0% at EMP-10. Midstreams (dip): 100% from EMP-1 to EMP+2, declining to 0% at EMP-10. Midstreams (simulated stream): 100% from EMP-3 to EMP+2, declining to 1% at EMP-10.
Lay User Study (Accuracy)	High agreement between lay users and professionals.	100% agreement between lay users and professionals for all formats (50 positive, 70 negative cases). For spiked samples, 100% positive at 10mIU/mL and 11.5mIU/mL, 1-2% positive at 5mIU/mL, and 43-46% positive at 8mIU/mL.
Lay User Study (Usability)	Easy to use, understandable labeling, correct interpretation of results by lay users.	Questionnaire results reflect that consumers found the device easy to use and had no trouble understanding labeling or interpreting results. Flesch-Kincaid reading analysis indicated an 8th-grade reading level for instructions.
Non-pregnant Urine Sample Analysis	Low to zero false positive rate in non-pregnant individuals.	0% false positive in pre-menopausal and menopausal groups, 1 false positive out of 300 (0.33%) in the post-menopausal group (>55 years old) due to naturally higher hCG levels.

2. Sample Size Used for the Test Set and Data Provenance

Analytical Performance (Precision/Reproducibility): For each hCG concentration, 50 samples were tested per lot, across 3 lots, for each of 3 formats (strips, cassettes, midstreams). This totals 450 samples per hCG concentration for each format (50 samples/lot * 3 lots * 3 sites * 1 investigator/site * 5 days = not explicitly detailed, but 50/50 for each lot implies 50 samples). This was conducted at 3 sites.
Analytical Performance (Detection Limit): 30 samples for each concentration, for 10 concentrations, per lot, across 3 lots, for each of 3 formats via 4 test methods (strip, cassette, midstream dip, midstream stream). (30 samples/concentration * 3 lots * 4 test methods = 360 samples per concentration level). Urine samples were from healthy non-pregnant women.
- Provenance: Data appears to be prospective as samples were spiked and tested. The country of origin for the samples is not explicitly mentioned but the applicant is from China, so it's likely China.
Method Comparison with Predicate Device: 120 urine samples tested simultaneously with the predicate device and the proposed devices.
- Provenance: Not specified if retrospective or prospective, but likely prospective for comparison.
Detection of hCG in Early Pregnancy Clinical Samples: 1287 urine samples collected from 99 different women (20-40 years old).
- Provenance: Prospective collection from women followed throughout their conception cycles. Specific country of origin is not mentioned, but given the applicant, likely China.
Lay User Study:
- First study (professional vs. non-professional comparison): 120 volunteers per site (50 pregnant, 70 non-pregnant) across 3 sites (one format per site). This totals 360 volunteers.
- Second study (spiked samples with lay users): 120 volunteers per site, detecting 4 spiked samples, across 3 sites.
- Provenance: Prospective, conducted on Chinese mainland with women volunteers (20-40 years old).
Non-pregnant Urine Sample Analysis: 900 samples tested across three clinical trial sites, with 100 samples from each of three age groups (pre-menopausal, menopausal, post-menopausal) per site, per format (not explicitly stated if per format, but described as "one format of device from 3 lots").
- Provenance: Not specified if retrospective or prospective. Likely collected specifically for the study.

3. Number of Experts and Qualifications for Ground Truth

Clinical Samples (Early Pregnancy): "laboratory technicians (one for strip, one for cassette format, and one for midstream for both dip and stream methods)" performed the initial testing. The ultimate ground truth for positive samples was confirmed with "ultrasound scan." No specific number or qualifications for the laboratory technicians or sonographers are provided beyond "laboratory technicians."
Lay User Study: "professionals" tested the simultaneously collected urine samples, and their results were used as ground truth for comparison with lay users. No specific number or qualifications of these "professionals" are detailed.
Non-pregnant Urine Sample Analysis: "professionals" tested the samples. For the false positive in the post-menopausal group, the concentrations of these samples "were determined to be higher than the cut-off of the device by quantitative test," implying a quantitative lab test was the ground truth for that specific follow-up.

4. Adjudication Method for the Test Set

Analytical Performance (Precision/Reproducibility & Detection Limit): "1 investigator" per site for precision tests, and "12 laboratory operators" divided into 4 groups for detection limit tests. There is no explicit mention of an adjudication method among multiple readers for these analytical studies. Results are aggregated.
Clinical Samples (Early Pregnancy): One laboratory technician per format/method combination performed the initial testing. The ultimate confirmation for positive results was "ultrasound scan." There is no mention of explicit adjudication among multiple human readers for initial interpretations.
Lay User Study: Professionals served as the ground truth for comparison with lay users. There is no mention of an adjudication method among these professionals if multiple were involved in reading the "ground truth" results for each sample. For the lay user study where spiked samples were tested by lay users, the ground truth was the known concentration of hCG in the spiked samples.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No formal MRMC comparative effectiveness study was done to compare human readers with and without AI assistance. This device is a rapid diagnostic test (lateral flow immunoassay) that provides a visual qualitative result (lines present or absent) directly to the user or a healthcare professional, not an AI-powered image analysis system. Therefore, the concept of "AI assistance" in the context of improving human reader performance is not applicable here.

6. Standalone Performance

Yes, a standalone performance was done. The entire analytical and clinical performance sections detail the algorithm's (device's) performance without human-in-the-loop directly influencing the result generation. For instance, the analytical sensitivity, specificity, and comparison with a predicate device are all examples of the device's standalone performance. The "lay user study" and "non-pregnant urine sample analysis" also contribute to understanding the device's performance when interpreted by humans (lay users or professionals).

7. Type of Ground Truth Used

Analytical Performance:
- Precision/Reproducibility & Detection Limit: Known concentrations of spiked HCG standard in negative urine samples.
- Cross-reactivity & Interference: Known concentrations of interfering substances spiked into negative and positive (10 mIU/mL hCG) urine samples.
- pH & Specific Gravity: Known pH and specific gravity values of urine samples.
- High Dose Hook Effect: Known high concentrations of hCG.
Clinical Samples (Early Pregnancy): "Ultrasound scan" confirmed positive pregnancy. For non-pregnant cases, it implies absence of ultrasound-confirmed pregnancy.
Lay User Study:
- Professional Comparison: Results from testing by "professionals" using the same urine samples as lay users.
- Spiked Samples: Known concentrations of hCG in the spiked urine samples.
Non-pregnant Urine Sample Analysis: Absence of pregnancy (based on age group and general health status) and, for the false positive case, validation by "quantitative test" for hCG concentration.

8. Sample Size for the Training Set

The provided document describes premarket testing and clinical studies to evaluate the device. It does not mention a training set or a machine learning (AI) algorithm that would typically require such a set. This is a traditional in-vitro diagnostic device.

9. How the Ground Truth for the Training Set Was Established

Since no training set for an AI algorithm is mentioned, this question is not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

February 22, 2019

Runbio BioTech Co.,Ltd Lyn Chen Official Correspondent Rongsheng Technological Zone, University Road Shantou, Guangdong 515063, China

Re: K181551

Trade/Device Name: DAVID One Step Home Use Pregnancy Test Strip DAVID One Step Home Use Pregnancy Test Midstream DAVID One Step Home Use Pregnancy Test Cassette DAVID One Step Prescription Pregnancy Test Strip DAVID One Step Prescription Pregnancy Test Cassette Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Codes: LCX, JHI Dated: January 8, 2019 Received: January 10, 2019

Dear Lyn Chen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of

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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Kellie B. Kelm -S

for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) K181551

Device Name

DAVID One Step Prescription Pregnancy Test Strip

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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510(k) Number (if known) K181551

Device Name

DAVID One Step Prescription Pregnancy Test Cassette

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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510(k) Number (if known) K181551

Device Name

DAVID One Step Home Use Pregnancy Test Strip

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
------------------------------------------------------------	-----------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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510(k) Number (if known) K181551

Device Name

DAVID One Step Home Use Pregnancy Test Midstream

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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510(k) Number (if known) K181551

Device Name

DAVID One Step Home Use Pregnancy Test Cassette

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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510(k) SUMMARY

The Assigned 510(k) number is K181551.

DATE of Summary: December 29,2018

A. Applicant

1.Company Name: RUNBIO BIOTECH CO., LTD
2.Address: RONGSHENG TECHNOLOGICAL ZONE,UNIVERSITY ROAD

SHANTOU, GUANGDONG, CHINA 515063

3.Telephone No.: 86-754-88116918
4.Fax: 86-754-88116915

B. Contact Information

1.Contact Person: LYN CHEN

2.Company Name: RUNBIO BIOTECH CO.,LTD
3.Address: RONGSHENG TECHNOLOGICAL ZONE.UNIVERSITY ROAD

SHANTOU, GUANGDONG, P.R.CHINA 515063

4.Telephone No.: 86-754-82758965

5.Fax No.: 86-754-88116915

6.E-mail Address:tech@runbio-bio.com

C. 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

D. Regulatory Information

1.Regulation section:

21 CFR 862.1155 Human Chorionic Gonadotropin (HCG) test system

2.Classification:
Class II

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3.Product Code:

LCX: Kit, test, pregnancy, hCG, over the counter

JHI: visual, pregnancy, hcg, prescription use

4.Panel:

Chemistry (75)

E.Intended Use/Indication(s) for use

1.Intended Use:

See Indications for use below.

2.Indications for use:

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

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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.

1. Special instrument requirements:
  None

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F. Device Description:

The added plastic housing does not affect the performance of the product, which is determined by the test strip. The only difference between the different formats is test procedure.

G. Substantial Equivalence Information

1.Predicate Device Name(s):

Church & Dwight Co., Inc., FIRST RESPONSE Early Result Pregnancy Test

2.Predicate 510(K)Number(s):

K123436

3. Comparison with predicate

Similarities
Item	Proposed Device	Predicate device
Product Name	DAVID One Step Pregnancy Test	FIRST RESPONSE EarlyResult Pregnancy Test
Intended Use	aid in early detection of pregnancy	Same
Early Detectionclaim	Detects pregnancy as early as 5 days before theexpected period or as early as 6 days before theday of the missed period.	Same
Results	Qualitative	Same
Test Principle	Sandwich Immunochromatographic Assay	Same
AnalyticalSensitivity	10mIU/mL	Same

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Differences
Item	Proposed Device	Predicate device
Product Name	DAVID One Step Pregnancy Test	FIRST RESPONSEEarly ResultPregnancy Test
Device format	Strip, Cassette, Midstream	Midstream
Intended User	Prescription use (strip and cassette) and OTC use(strip, cassette and midstream)	OTC Use
Time to Result	5 minutes	3 minutes
Specificity	LH at 500 mIU/mL, FSH at 1000 mIU/mL, andTSH at 1000 $ μ $ IU/mL	hLH and hFSH at1000 mIU/mL, hTSHat 1 mIU/mL
High DosageHook effect	No high dosage hook effect for hCG up to2000,000 mIU/mL	No high dosage hookeffect for hCG up to500 IU/mL.

H. Guidance Document:

None were referenced

I. Test Principle:

The test is a qualitative, solid phase, double antibodies sandwich immunochromatographic assay.

During the test, hCG in the urine specimen reacts with the dye conjugate (mouse anti-ß-hCG antibody- colloidal gold conjugate specific to the beta subunit of hCG) and forms a complex. The complex migrates along the membrane to the mouse anti-a-hCG antibody test region (T), and remains captured in the T line.

J. Performance Characteristics:

1. Analytical performance

a. Precision/Reproducibility

Dilute HCG standard with negative urine samples from healthy women to different concentrations: HCG7.5mIU/mL, HCG9mIU/mL, HCG 10mIU/mL, HCG15mIU/mL and HCG25mIU/mL.

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In each site of the 3 sites, one format of reagent will be used for detection by 1 investigator. In each day of test, 10pcs of reagents from each lot, totally 3 lots, will be used for detection. Test will be conducted every other day, totally 5 days.

hCG Concentration	LOT1	LOT2	LOT3	% positive
HCG0mIU/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%

Table: statistics of test results by strips

Table: statistics of test results by cassettes

hCG Concentration	LOT1	LOT2	LOT3	% positive
HCG0mIU/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%

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hCG Concentration	LOT1	LOT2	LOT3	% positive
HCG0mIU/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%

Table: statistics of test results by midstreams

b. Linearity/assay reportable range:
Linearity is not applicable since this is a qualitative test.
c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability:
The tests is calibrated against the WHO International Standard 5th WHO Chorionic Gonadotrophin ( ( NIBSC code: 07/364 )

Stability:

The stability testing protocol and acceptance criteria used to support the shelf life were reviewed and found to be acceptable. The sponsor claims a 30-month shelf life for all three test formats when stored in the sealed foil pouch at 36-86°F (2-30°C).

Expected values :

1. Negative results are expected in healthy non-pregnant women.

The amount of hCG will vary greatly with gestational age and between individuals.

d. Detection limit:
Select 30 healthy non-pregnant women and collect their urine samples as basic diluted urine. Separate each sample into 10 sets respectively, each of which is spiked with HCG standard to get required concentrations, respectively are : HCG0mIU/mL、 HCG3mIU/mL, HCG HCG7.5mIU/mL, HCG9mIU/mL, HCG 10mIU/mL, HCG12.5mIU/mL ,

{14}------------------------------------------------

HCG15mIU/mL and HCG25mIU/mL. There are 30 samples for each concentration. All the samples are re-numbered and divided into 4 sets,so each group of samples have 10 different concentrations and each concentration is made with negative urine sample from 30 different women. All the samples are stored below -20

There were 3 formats of reagent for assessment: strip, cassette and midstream. There were two test methods for the midstream format: the dip method and the simulated stream method. For each format, 3 lots of reagents would be used for test.

12 laboratory operators were selected to carry out this test based on different test methods. The 12 operators would be separated into 4 groups, 3 for each group, and then respectively test with strips, cassettes , midstreams (the dip method) and midstreams (the simulated stream method).

hCG concentration	LOT1	LOT2	LOT2	% positive
HCG0mIU/mL	+/+(0/30)	+/+(0/30)	+/+(0/30)	0%
HCG 3mIU/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%

Table: Summary of Test Results by Strips

Table: Summary of Test Results by Cassettes

hCG concentration	LOT1	LOT2	LOT2	% positive
HCG0mIU/mL	+/+(0/30)	+/+(0/30)	+/+(0/30)	0%
HCG 3mIU/mL	+/+(0/30)	+/+(1/30)	+/+(0/30)	1%
HCG5mIU/mL	+/+(1/30)	+/+(0/30)	+/+(1/30)	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%
HCG13mIU/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%

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hCG concentration	LOT1	LOT2	LOT2	% positive
HCG0mIU/mL	+/+(0/30)	+/+(0/30)	+/+(0/30)	0%
HCG 3mIU/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%
HCG13mIU/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%

Table: Summary of Test Results by Midstreams (the dip method)

Table: Summary of Test Results by Midstreams (the simulated stream method)

hCG concentration	LOT1	LOT2	LOT2	% positive
HCG0mIU/mL	+/+(0/30)	+/+(0/30)	+/+(0/30)	0%
HCG 3mIU/mL	+/+(0/30)	+/+(0/30)	+/+(1/30)	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%
HCG13mIU/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%

The results demonstrated that the analytical sensitivity of the new device (the lowest concentration that yields 100% positive results) was 10mIU/mL and the cut-off level (at which approximately half of the devices yield positive results and the remainder yield negative results) was 7.5 mIU/mL.

e. Analytical specificity:

Cross reactivity:

To evaluate cross-reactivity, 20 fresh urine specimens obtained from 10 healthy non-pregnant women and 10 healthy men were spiked with different concentrations of Lutenizing Hormone (LH), Follicle stimulating Hormone (FSH), and thyroid stimulating hormone (TSH) into negative (0 mIU/mL) and positive (10mIU/ml) samples. The results demonstrated no cross reaction with LH at 500mIU/ml, FSH at 1000 mIU/mL, and TSH at 1000μIU/mL.

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Interference:

A study was conducted to evaluate interference of specific exogenous compounds. Negative and positive hCG urine samples (10 mIU/mL) were individually spiked with the substances listed in the table below. Three devices of each format were tested. No interference was observed from the compounds at the concentrations listed below.

Name	Concentration	Name	Concentration
Glucose	20mg/mL	Bilirubin	20µg/mL
Albumin	20mg/mL	estriol	10μg/mL
Hemoglobin	10μg/mL

Table common birth control pills and progestational drugs

Name	Concentration	Name	Concentration
Levonorgestrel	11.8mg/mL	Ethynylestradiolcyproterone	2mg/mL
Bromocriptine mesylate	2.5mg/mL	Progesterone	100mg/mL
Clomiphene citrate	50mg/mL	Medroxyprogesteroneacetate	2mg/mL
Letrozole	2.5mg/mL	Ethinylestradiol	13.8mg/mL
		Estradiol	13.6mg/mL

Table: prescription and OTC use exogenous substances

Name	Concentration	Name	Concentration
Acetaminophen	200µg/mL	Phenothiazine	200µg/mL
Acetylsalicylic Acid	200µg/mL	Phenylpropanolamine	200µg/mL
Ascorbic Acid	200µg/mL	Tetracycline	200µg/mL
Ampicillin	200µg/mL	Ephedrine	200µg/mL
Atropine	200µg/mL	Aspirin	200µg/mL
Caffeine	200µg/mL	Thiophene	200µg/mL
Gentisic Acid	200µg/mL	Salicyclic Acid	200µg/mL
		Ethanol	1%

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Name	Concentration	Name	Concentration
Amikacin	15 mg/dL	Kanamycin A	10 mg/dL
Amphotericin B	10µg/mL	Kanamycin B	10mg/dL
Cefdinir	100µg/mL	Penicillin G	100µg/mL
Cefuroxime	100µg/mL	Rifampin	5mg/dL
Cephradine	100µg/mL	Spectinomycin	100µg/mL
Ciprofloxin	10µg/mL	Tobramycin	2mg/dL
Gentamicin	15mg/dL	Vancomycin	6mg/dL

Table: antibiotic

Effects of Urine pH:

A study was conducted to evaluate the effect of pH. Negative and positive hCG urine samples (10 mIU/mL) were tested across a pH range of 4-9. The results demonstrate that pH ranging from 4 to 9 in urine samples does not interfere with the performance of the test.

Specific Gravity:

A study was performed to evaluate the effects of urine specific gravity on the device. The device was challenged with negative urine and positive urine with specific gravity from 1.000 to 1.050. The results demonstrate that specific gravity ranging from 1.000 to 1.050 in urine samples does not interfere with the performance of the test.

High dose hook effect study:

The test was evaluated for high dose hook effect. Negative urine specimens were spiked with high hCG concentration of up to 2000,000 mIU/mL. All samples yielded the expected results. This study demonstrates that this device shows no hook effect up to 2,000,000 mIU/mL hCG.

Effects of hCG ß-core Fragment:

Interference testing was performed to evaluate whether high levels of beta core fragment interfere with the device. Negative urine hCG and positive urine samples (containing 10 mIU/mL hCG) were spiked with hCG beta core fragment at concentrations of62,500, 125,000, 250,000, and 1,000,000 pmol/L. Concentrations of hCG beta core fragment up to 1,000,000 pmol/L yielded correct

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Interference from hCG p-core fragment was demonstrated at results. concentrations of 1,000,000 pmol/L.

1. Comparison Study:
  a. Method comparison with predicate device:

Tests were conducted at 3 different sites. In each site, 120 urine samples were simultaneously double-blind tested by professionals using both predicate devices and one format of proposed devices. Simultaneously, two test methods of midstream, the dip method and the simulated stream method, would be compared.

		Predicate Device
		Positive	Negative	total
ProposedDevice	Positive	(a)52	(b)0	(a+b)52
ProposedDevice	Negative	(c)0	(d)68	(c+d)68
	total	(a+c)52	(b+d)68	(a+b+c+d)120

Table: statistic analysis of data of strips

Table: statistic analysis of data of cassettes

		Predicate Device
		Positive	Negative	total
ProposedDevice	Positive	(a)64	(b)0	(a+b)64
	Negative	(c)0	(d)56	(c+d)56
	total	(a+c)64	(b+d)56	(a+b+c+d)120

Table: statistic analysis of data of midstream (the dip method)

		Predicate Device
		Positive	Negative	total
ProposedDevice	Positive	(a)73	(b)0	(a+b)73
	Negative	(c)0	(d)47	(c+d)47
	total	(a+c)73	(b+d)47	(a+b+c+d)120

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		the dip method by proposed device
		Positive	Negative	total
the simulated stream method byproposed device	Positive	(a)73	(b)0	(a+b)73
proposed device	Negative	(c)0	(d)47	(c+d)47
	total	(a+c)73	(b+d)47	(a+b+c+d)120

Table: statistic analysis of data of midstream

b. Matrix comparison:
Not applicable. The device is for use with urine samples only.
1. Clinical studies:
- a. Clinical Sensitivity:

Not applicable

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

Detection of hCG in Early Pregnancy Clinical Samples

A total of 1287 urine samples were collected from 99 different women (20-40 years old) who planned to become pregnant. These women were followed throughout their conception cycles with urine collected from day -10 to day 2 of their expected period. These 1287 samples were then tested by laboratory technicians (one for strip, one for cassette format, and one for midstream for both dip and stream methods). Urine samples were masked and randomized by people who prepared samples but did not participate in the testing. One lot of each test device was used. At last, confirm all positive samples with ultrasound scan.

{20}------------------------------------------------

Day relativeto EMP	Overall PregnancyDetection Rate (%)	Number of positivesamples	Number ofnegative samples	Day in cycle relative toEMP
+2	100%	99	0	EMP+2
+1	100%	99	0	EMP+1
0	100%	99	0	EMP
-1	100%	99	0	EMP-1
-2	99%	98	1	EMP-2
-3	99%	98	1	EMP-3
-4	96%	95	4	EMP-4
-5	78%	77	22	EMP-5
-6	38%.	38	61	EMP-6
-7	17%	17	82	EMP-7
-8	7%	7	92	EMP-8
-9	3%	3	96	EMP-9
-10	0%	0	99	EMP-10

Table: results by strip

Table: results by cassette

Day relativeto EMP	Overall PregnancyDetection Rate (%)	Number of positivesamples	Number ofnegative samples	Day in cycle relative toEMP
+2	100%	99	0	EMP+2
+1	100%	99	0	EMP+1
0	100%	99	0	EMP
-1	100%	99	0	EMP-1
-2	100%	99	0	EMP-2
-3	98%	97	2	EMP-3
-4	97%	95	4	EMP-4
-5	77%	76	23	EMP-5
-6	37%.	37	62	EMP-6
-7	17%	17	82	EMP-7
-8	9%	8	91	EMP-8
-9	5%	5	94	EMP-9
-10	0%	0	99	EMP-10

Table: results by midstream (the dip method)

Day relativeto EMP	Overall PregnancyDetection Rate (%)	Number of positivesamples	Number ofnegative samples	Day in cycle relative toEMP
+2	100%	99	0	EMP+2
+1	100%	99	0	EMP+1
0	100%	99	0	EMP
-1	100%	99	0	EMP-1
-2	99%	98	1	EMP-2
-3	99%	98	1	EMP-3
-4	97%	96	3	EMP-4
-5	77%	76	23	EMP-5
-6	38%	38	61	EMP-6
-7	18%	18	81	EMP-7
-8	7%	7	92	EMP-8
-9	3%	3	96	EMP-9
-10	0%	0	99	EMP-10

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Day relative to EMP	Overall Pregnancy Detection Rate (%)	Number of positive samples	Number of negative samples	Day in cycle relative to EMP
+2	100%	99	0	EMP+2
+1	100%	99	0	EMP+1
0	100%	99	0	EMP
-1	100%	99	0	EMP-1
-2	100%	99	0	EMP-2
-3	100%	99	0	EMP-3
-4	97%	96	3	EMP-4
-5	80%	80	19	EMP-5
-6	39%	39	60	EMP-6
-7	19%	19	80	EMP-7
-8	9%	9	91	EMP-8
-9	4%	4	95	EMP-9
-10	1%	1	98	EMP-10

Table: results by midstream (simulated stream method)

Layuser study

This study was performed at 3 sites on Chinese mainland. Chose women volunteers who had certain English reading ability and were willing to take time to assist the site to complete the test without compensation. These volunteers should have diverse educational and professional background but without corresponding medical background and their age range were between 20 and 40 years old.

Each unit completed the selection of 120 volunteers to conduct this lay user study, of which 50 were pregnant women and 70 were non-pregnant women.

Each site completed a study of a format, and the midstream format was used for test by simulated stream method and dip method.

All volunteers, after reading the English manual of the corresponding format of the product provided by the applicant, independently completed the collection, detection and result judgment of their urine samples without the assistance of professionals. The simultaneously collected urine samples by the volunteers were detected by professionals after blinded (the people who blinded the samples do not participate in the test). The test results of the professional and non-professional were summarized as follows:

{22}------------------------------------------------

results by professionals Positive Negative total Proposed Device Positive (a)50 (b)0 (a+b)50 results by Negative (d)70 (c)0 (c+d)70 non-professionals (a+b+c+d)120 total (a+c)50 (b+d)70

Table: statistic analysis of data of strips

Table: statistic analysis of data of cassettes

		results by professionals
		Positive	Negative	total
Proposed Deviceresults bynon-professionals	Positive	(a)50	(b)0	(a+b)50
Proposed Deviceresults bynon-professionals	Negative	(c)0	(d)70	(c+d)70
Proposed Deviceresults bynon-professionals	total	(a+c)50	(b+d)70	(a+b+c+d)120

Table: statistic analysis of data of midstreams

		results by professionals
		Positive	Negative	total
Proposed Deviceresults bynon-professionals	Positive	(a)50	(b)0	(a+b)50
	Negative	(c)0	(d)70	(c+d)70
	total	(a+c)50	(b+d)70	(a+b+c+d)120

Table: statistic analysis of data of midstreams (non-professionals)

		the dip method with proposed device
		Positive	Negative	total
the simulated streammethod withproposed device	Positive	$(a)50$	$(b)0$	$(a+b)50$
the simulated streammethod withproposed device	Negative	$(c)0$	$(d)70$	$(c+d)70$
	total	$(a+c)50$	$(b+d)70$	$(a+b+c+d)120$

The second study is conducted with diluted samples.

120 volunteers at each site detect 4 samples containing different concentration of HCG, HCG 5mIU/mL, HCG 8mIU/mL, HCG 10mIU/mL and HCG11.5mIU/mL, after collection of their own urine samples. The midstream format will be used for detection in the dip method and the simulated stream method. The testing was performed at 3 intended use sites. One lot of each of the three test formats were used in the study.

{23}------------------------------------------------

		Lay users Results
concentration	Test Sample	Number of Positive	Number of Negative	% positive

HCG 5mUI/mL	Sample 1	2	118	2%
HCG 10mIU/mL	Sample 2	120	0	100%
HCG 11.5mIU/mL	Sample 3	120	0	100%
HCG 8mIU/mL	Sample 4	52	68	43%

Table: Statistical table of test results of samples spiked with HCG (Strip )

Table: Statistical table of test results of samples spiked with HCG (Cassette )

concentration	Test Sample	Lay users Results		% positive
		Number of Positive	Number of Negative
HCG 5mUI/mL	Sample 1	1	119	1%
HCG 10mIU/mL	Sample 2	120	0	100%
HCG 11.5mIU/mL	Sample 3	120	0	100%
HCG 8mIU/mL	Sample 4	55	65	46%

Table: Statistical table of test results of samples spiked with HCG (Midstream)

		Lay users Results
concentration	Test Sample	Number ofPositive	Number ofNegative	% positive
HCG 5mUI/mL	Sample 1	1	119	1%
HCG 10mIU/mL	Sample 2	120	0	100%
HCG 11.5mIU/mL	Sample 3	120	0	100%
HCG 8mIU/mL	Sample 4	54	66	45%

The results show that when use the product to detect samples spiked with HCG at concentrations which are above or below the detection limit (HCG10mIU/mL), for samples whose HCG concentrations are 5mIU/mL, 1-2 of the test results is positive, and for samples whose HCG concentrations are 10mIU/mL, all the results are positive.

Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. If you test positive, but think you may not be pregnant, you should check with your doctor.

360 volunteers who have finished the study with clinical samples were willing to do a questionnaire survey. All the questions in the questionnaire were in Likert scale style. At the same time, a Flesch-Kincaid reading analysis is performed on each package insert and the score demonstrates a reading Grade Level of 8.The

{24}------------------------------------------------

results of the questionnaire reflects that the consumers find the device easy to use and that they do not have trouble understanding the labeling or interpreting results.

Non-pregnant urine sample analysis :

A total of 900 samples were tested in three clinical trial sites by professionals. In each unit, there were 100 samples for each age group, and one format of device from 3 lots would be used for detection.

Age Group	Test Result
	Positive	Negative
pre-menopausal group(18-40)	+/+(0/300)	-/-(300/300)
menopausal group(41-55)	+/+(0/300)	-/-(300/300)
post menopausal group(> 55)	+/+(1/300)	-/-(299/300)

Table: statistics of test results

As can be seen from the test results in the above table, 1 false positive result occurred in non-pregnant women over 55 years old. The concentrations of these samples were determined to be higher than the cut-off of the device by quantitative test.

3.Clinical cut-off:
Not applicable
1. Expected values/Reference range:
  Not applicable.

M. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

N. CONCLUSION:

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

Regulation Number and Section

§ 862.1155 Human chorionic gonadotropin (HCG) test system.

(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)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.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. 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.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.