MissLan® Pregnancy Rapid Test (Strip) is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, as an aid in early detection of pregnancy. It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over the counter use.

MissLan® Pregnancy Rapid Test (Midstream) is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, as an aid in early detection of pregnancy. It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over the counter use.

Device Description

MissLan® Pregnancy Rapid Test will be sold in Midstream and Strip format. The Midstream format consists of a single test strip assembled in a plastic housing, with an absorbent tip, and is designed to be tested in dip or midstream mode. The Strip format is a single test strip. The Midstream format contains one Test Midstream sealed in a desiccated aluminum pouch and Instructions for Use. The Strip format contains one Test strip sealed in a desiccated aluminum pouch, Urine Collection Cup and Instructions for Use. The device is in a ready-to-use format and does not require assembly before use.

AI/ML Overview

Here is a summary of the acceptance criteria and study details for the MissLan® Pregnancy Rapid Test (Strip) and MissLan® Pregnancy Rapid Test (Midstream), based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Comments
Analytical Sensitivity (Detection Limit)	25 mIU/mL hCG detectable with 100% positive rate.	Achieved 100% positive results for 25 mIU/mL hCG across all operators, lots, and formats (Midstream (in-stream & dip), Strip).	Confirmed.
Reproducibility	Consistent results across different operators, lots, and days.	Observed reproducibility of results for all formats with varying hCG concentrations. (e.g., 25 mIU/mL consistently 100% positive, 0 and 12.5 mIU/mL consistently 100% negative).	Confirmed.
Hook Effect	No hook effect observed at high hCG concentrations.	No hook effect observed up to 500,000 mIU/mL hCG, all samples tested positive.	Confirmed.
Specificity (False Positives)	No false positive results in non-pregnant individuals.	No false positive results observed in 450 urine samples from normal, non-pregnant females across three age groups and all device formats.	Confirmed.
Cross-Reactivity	No cross-reactivity with hLH, hFSH, or hTSH at specified concentrations.	No cross-reactivity observed with 500 mIU/mL hLH, 1000 mIU/mL hFSH, 1000 µIU/mL hTSH.	Confirmed.
hCG ß-core fragment Interference	No interference from hCG ß-core fragment at specified concentrations.	Performance not affected by hCG ß-core fragment concentrations up to 500,000 pmol/L.	Confirmed.
Exogenous & Endogenous Interfering Substances	No interference from a panel of common substances at specified concentrations.	No interference effect observed for the listed substances (e.g., Glucose, Albumin, Hemoglobin, common medications) at tested concentrations.	Confirmed.
Urine pH Effect	Performance unaffected by urine pH within a specific range.	Performance unaffected by urine pH ranging between 4 and 9.	Confirmed.
Urine Density Effect	Performance unaffected by urine density within a specific range.	Performance unaffected by urine with a relative density up to 1.035.	Confirmed.
Method Comparison (Conformity with Predicate)	100% conformity with the predicate device for positive and negative samples.	100% conformity achieved between MissLan® Pregnancy Rapid Test (all formats) and the predicate device across tested urine samples.	Confirmed.
Lay Person Study (Accuracy of Self-Testing)	100% concordance with professional results for positive and negative samples; 100% correct results for spiked samples (5 mIU/mL negative, 25 mIU/mL positive); ease of use and readability of labeling.	Achieved 100% positive and 100% negative conformity with professional results in the first study (100 women per format). Achieved 100% correct results for 5 mIU/mL and 25 mIU/mL spiked samples in the second study (100 laypersons per concentration). Questionnaire confirmed ease of use and understanding.	Confirmed.

2. Sample Size for Test Set and Data Provenance

Analytical Performance (Precision/Reproducibility/Sensitivity):
- For each hCG concentration (0, 12.5, 15, 18.75, 22.5, 25, 50, 100, 200 mIU/mL), 10 replicates were tested per day for 5 days for each of 3 device lots. This means 50 tests per operator/lot/concentration.
- Total tests for Strip format: 9 concentrations * 50 replicates/operator * 3 operators = 1350 tests.
- Total tests for Midstream format (in-stream): 9 concentrations * 50 replicates/operator * 3 operators = 1350 tests.
- Total tests for Midstream format (dip): 9 concentrations * 50 replicates/operator * 3 operators = 1350 tests.
- Total for Sensitivity: 4050 unique test interpretations.
- Data Provenance: Not explicitly stated, but likely laboratory-prepared samples.
Specificity (Cross-reactivity with non-pregnant samples):
- Sample Size: 450 urine samples (150 from pre-menopausal, 150 from peri-menopausal, 150 from post-menopausal women).
- Each age group had 50 participants tested with strip, 50 with midstream (dip), and 50 with midstream (in-stream).
- Data Provenance: Not explicitly stated but implies prospective collection of urine from normal, non-pregnant females.
Method Comparison Study:
- Sample Size: 200 urine samples (approximately half suspected pregnant, most in early stage < 5 weeks).
- Data Provenance: Collected from women presenting to test for pregnancy, likely prospective clinical samples. The samples were split to test different device formats:
  - Strip Device: 200 samples (101 positive, 99 negative)
  - Midstream Device (in-stream method): 100 samples (52 positive, 48 negative)
  - Midstream Device (dip method): 100 samples (49 positive, 51 negative)
Lay Person Study:
- First Study (Self-testing vs. Professional): 200 women.
  - Strip device: 100 women (52 positive, 48 negative)
  - Midstream device (in-stream): 50 women (26 positive, 24 negative)
  - Midstream device (dip): 50 women (23 positive, 27 negative)
- Second Study (Spiked Samples): 200 laypersons.
  - 100 laypersons tested 5 mIU/mL hCG aliquots.
  - 100 laypersons tested 25 mIU/mL hCG aliquots.
- Data Provenance: Collected from individuals with varying educational and occupational backgrounds from three sites, presumably prospective.

3. Number of Experts and Qualifications for Ground Truth

Analytical Performance: The ground truth for spiked samples was based on the known, precisely controlled concentration of hCG, traceable to the 5th WHO International Standard. The "operators" (presumably laboratory technicians or trained personnel doing the reading) were involved in testing, but the ground truth for the hCG concentration itself was intrinsic to the sample preparation.
Method Comparison Study: The ground truth was established by testing the same samples with a predicate device. While not explicitly stated as "experts," the "three POC sites (3 different professionals using the candidate device and 1 professional using the predicate device at each site)" implies trained professionals made the readings for both the candidate and predicate devices. No specific qualifications (e.g., years of experience) are provided.
Lay Person Study (First Study): The ground truth was established by "professional testing" of the same urine samples. It can be inferred that these were qualified laboratory personnel or healthcare professionals. No specific number or qualifications are provided beyond "professional."
Lay Person Study (Second Study): The ground truth was the known, precisely controlled concentration of hCG in the blindly labeled spiked samples (0 mIU/mL for 5 mIU/mL hCG aliquot which should be negative, and 25 mIU/mL hCG aliquot which should be positive according to the device's cut-off).

4. Adjudication Method for Test Set

Analytical Performance (Reproducibility): No explicit adjudication method is mentioned beyond testing by "three different operators." The data is presented as raw counts of negative/positive readings per operator/lot, not as an adjudicated consensus.
Method Comparison Study: The comparison was made directly between the candidate device and the predicate device results for each sample. Implicitly, any disagreement would be noted, but the results show 100% conformity, suggesting no need for complex adjudication.
Lay Person Study (First Study): The layperson's self-test results were compared directly against the "professional" results. No explicit adjudication process for discrepancies is described, though the 100% concordance implies disagreements were not observed or not significant enough to warrant further mention.
Lay Person Study (Second Study): The layperson's results were compared to the known spiked hCG concentration (the "true" positive or negative result). No explicit adjudication process is detailed.

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

No, an MRMC comparative effectiveness study was not done in the context of human readers improving with AI vs. without AI assistance.
This device is a rapid diagnostic test for home use (Over-The-Counter). The studies focus on analytical performance, comparison to a predicate device, and the ability of laypersons to correctly use and interpret the device (without assistance). There is no "AI assistance" component to this device.

6. Standalone (Algorithm Only) Performance

Yes, a standalone (algorithm only) performance equivalent was performed in the context of the device itself (without human-in-the-loop assistance for interpretation beyond reading the visual line).
The entire analytical performance section (sensitivity, hook effect, specificity, cross-reactivity, interfering substances, pH, density) evaluates the device's inherent capability to detect hCG under various conditions. The "reading" is visual, which is the intended standalone function for an OTC rapid test. The "operators" in these studies are effectively performing the standalone reading as intended by the device's design.

7. Type of Ground Truth Used

Known Spiked Concentrations: For analytical sensitivity, hook effect, cross-reactivity, interfering substances, pH, and density studies, the ground truth was based on precisely prepared urine samples with known concentrations of hCG or other substances.
Predicate Device Results: For the method comparison study, the results from a legally marketed predicate device served as the reference standard (ground truth).
Professional Testing: For the first layperson study, the results from trained professionals using the MissLan® Pregnancy Rapid Test served as the ground truth against which layperson self-test results were compared.

8. Sample Size for Training Set

The provided document describes a 510(k) summary for device clearance, which typically focuses on validation studies rather than a detailed breakdown of the development or training process.
No information is provided regarding the specific sample size used for a "training set" for the development of MissLan® Pregnancy Rapid Test. This is typical, as the 510(k) submission generally presents the results of validation testing for the final device, not the iterative development data.

9. How Ground Truth for Training Set Was Established

No information is provided on how the ground truth for a "training set" was established for this device, as the document does not detail the development phase.
Given that this is an immunochromatographic rapid diagnostic test, the "training" aspect would primarily relate to optimizing reagent concentrations, membrane characteristics, and buffer systems to achieve the desired analytical performance (e.g., sensitivity, specificity, read time) based on known hCG concentrations and interfering substances. The establishment of ground truth would follow standard laboratory practices for preparing calibrated samples and verifying analytical properties of the reagents.

Summary

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February 28, 2023

Guangzhou Decheng Biotechnology Co., Ltd. % Joe Shia, Director LSI International 504 E Diamond Ave., Suite I Gaithersburg, MD 20877

Re: K230038

Trade/Device Name: MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream) Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: January 5, 2023 Received: January 6, 2023

Dear Joe Shia:

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 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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Digitally signed by Paula Paula Caposino - Caposino -S Caposino -S
Caposino -S Date: 2023.02.28
17:36:04 -05:00 - 17:36:04 -05:00 Paula Caposino, Ph.D.

Acting Deputy Division Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230038

Device Name MissLan® Pregnancy Rapid Test (Strip) MissLan® Pregnancy Rapid Test (Midstream)

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

K230038

1.	Date:	February 26, 2023
2.	Submitter:	Guangzhou Decheng Biotechnology Co., Ltd.Building 2, No.68, Nanxiang 1st Road, ScienceCity, Huangpu District, Guangzhou, Guangdong,510000, China
3.	Contact person:	Joe ShiaLSI International Inc.504 East Diamond Ave., Suite IGaithersburg, MD 20877Telephone: 240-505-7880Fax: 301-916-6213Email: shiajl@yahoo.com
4.	Device Name:	MissLan® Pregnancy Rapid Test (Strip)MissLan® Pregnancy Rapid Test (Midstream)
	Classification:	Class II
	Product Code:	LCX
	CFR:	862.1155
5.	Predicate Devices:	One Step HCG Urine Pregnancy Test(K043443)

6. Intended Use

7. Device Description

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Similarities
Item	Candidate device	Predicate device
Intended use	Early detection ofpregnancy	Early detection ofpregnancy
Specimen	Urine	Urine
Assay technical	Immunochromatographicassay	Immunochromatographicassay
Sensitivity	25 mIU/mL	25 mIU/mL
Results	Qualitative	Qualitative
Read time	3-5 minutes	3-5 minutes
Differences
Item	Device	Predicate
Device format	Midstream, Strip	Midstream, Strip, Cassette
Target user	Over the counter use	For over-the-counter andprofessional use

8. Substantial Equivalence Information

9. Test Principle

MissLan® Pregnancy Rapid Test uses lateral flow immunoassay for in vitro qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. If hCG is present in the sample, it will reach the Test Zone ("T") of the membrane and form a colored line. When the test is performed properly, a colored line will always appear in the Control Zone ("C"). The test result is shown in the result window and read visually between 3 and 5 minutes of urine application. Two distinct colored lines, one in the Test Zone and another in the Control Zone indicate a positive test result (pregnant). Absence of a colored line in the Test Zone and only a colored line in the Control Zone indicates a negative test result (not pregnant). Absence of a colored line in the Control Zone even in the presence of a colored line in the Test Zone indicates an invalid test result.

10. Performance Characteristics

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A. Analytical performance

a. Precision/Reproducibility/Sensitivity

Negative female urine was spiked with hCG standard (Traceable to the 5th WHO) to hCG concentrations of 0, 12.5, 15, 18.75, 22.5, 25, 50, 100 and 200 mIU/mL. Each sample was tested in 10 replicates per day for 5 days for each device lot. Total of three device lots for each format were tested. Tests were performed by three different operators for each sample concentration. The results are summarized in the table below:

hCGConcentration(mIU/mL)	Operator 1Lot 1		Operator 2Lot 2		Operator 3Lot 3		Totalresult		%
	-	+	-	+	-	+	-	+	Negative	Positive
0	50	0	50	0	50	0	150	0	100%	0%
12.5	50	0	50	0	50	0	150	0	100%	0%
15	25	25	26	24	23	27	74	76	49.3%	50.7%
18.75	12	38	13	37	12	38	37	113	24.7%	75.3%
22.5	5	45	4	46	4	46	13	137	8.7%	91.3%
25	0	50	0	50	0	50	0	150	0%	100%
50	0	50	0	50	0	50	0	150	0%	100%
100	0	50	0	50	0	50	0	150	0%	100%
200	0	50	0	50	0	50	0	150	0%	100%

Midstream format (in-stream method)

Midstream format (dip method)

hCGConcentration(mIU/mL)	Operator1Lot 1		Operator2Lot 2		Operator3Lot 3		Totalresult		%Negative	%Positive
	-	+	-	+	-	+	-	+
0	50	0	50	0	50	0	150	0	100%	0%
12.5	50	0	50	0	50	0	150	0	100%	0%
15	25	25	27	23	24	26	76	74	50.7%	49.3%
18.75	12	38	13	37	13	37	38	112	25.3%	74.7%
22.5	5	45	5	45	4	46	14	136	9.3%	90.7%
25	0	50	0	50	0	50	0	150	0%	100%
50	0	50	0	50	0	50	0	150	0%	100%
100	0	50	0	50	0	50	0	150	0%	100%
200	0	50	0	50	0	50	0	150	0%	100%

Strip format

hCGConcentration	Operator1	Operator2	Operator3	Totalresult	%Negative	%Positive
----------------------	---------------	---------------	---------------	-----------------	---------------	---------------

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(mIU/mL)	Lot 1		Lot 2		Lot 3
	-	+	-	+	-	+	-	+
0	50	0	50	0	50	0	150	0	100%	0%
12.5	50	0	50	0	50	0	150	0	100%	0%
15	25	25	24	26	24	26	73	77	48.7%	51.3%
18.75	11	39	12	38	13	37	36	114	24.0%	76.0%
22.5	5	45	4	46	5	45	14	136	9.3%	90.7%
25	0	50	0	50	0	50	0	150	0%	100%
50	0	50	0	50	0	50	0	150	0%	100%
100	0	50	0	50	0	50	0	150	0%	100%
200	0	50	0	50	0	50	0	150	0%	100%

MissLan® Pregnancy Rapid Test exhibited reproducibility of results.

Based on the above results, the sensitivity of MissLan® Pregnancy Rapid Test is demonstrated to be 25 mIU/mL.

b. Linearity/assav reportable range:

Linearity is not applicable since this is a qualitative test. The test device was evaluated for high dose or hook effect.

Hook effect test:

Negative urine samples were spiked with varying hCG concentrations (6.250 mIU/mL, 12,500 mIU/mL, 25,000 mIU/mL, 50,000 mIU/mL, 100,000 mIU/mL, 200,000 mIU/mL and 500,000 mIU/mL). All tested concentrations gave a positive result. The results demonstrated that no hook effect was observed at hCG concentration up to 500,000 mIU/mL.

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

MissLan® Pregnancy Rapid Test is calibrated against reference material traceable to WHO International Standard 5th edition, NIBSC code 07/364.

Stability:

A 32-month real time stability test is planned to verify the shelf-life stability of the device. Three batches for each format in sealed foil pouch are currently stable for 30 months at 2°C and 30°C, and the real time stability study is still on going.

d. Specificity and cross reactivity

To evaluate specificity, 450 urine samples were collected from normal, nonpregnant female in pre-menopausal (ages 18~~40 years old), peri-menopausal (41~~55 years old) and post-menopausal (>55 years old) groups. 150 people for each age group. In each age group, 50 participants were tested with test strip, 50 participants were tested with test midstream using dip method, and 50 participants

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tested with test midstream using in-stream method. No false positive results were observed for any of the age groups.

To evaluate cross-reactivity, negative and positive urine samples (0, 5 and 25 mIU/mL hCG) were spiked with potential cross reactants (500 mIU/mL hLH, 1000 mIU/mL hFSH, 1000 µIU/mL hTSH). No cross-reactivity was observed at tested concentration.

To evaluate the effect of the hCG ß-core fragment, Negative urine samples (0 and 5 mIU/mL hCG) and positive urine samples (25 and 20,000 mIU/mL hCG) were spiked with hCG ß-core fragment (hCGBcf) at concentrations of 50,000 pmol/L, 125,000 pmol/L, 250,000pmol/L and 500,000pmol/L. The performance of MissLan® Pregnancy Rapid Test is not affected by hCG ß-core fragment concentrations up to 500,000 pmol/L.

e. Interfering substance

To evaluate potential interferers with MissLan® Pregnancy Rapid Test, urine samples containing 0, 5 and 25 mIU/mL hCG were spiked with the interfering substance to obtain the certain desired test concentration. No interference effect was observed at the tested concentration shown in table below:

Substance	Concentration
Glucose	2000 mg/dL
Albumin	2000 mg/dL
Bilirubin	40 mg/dL
Hemoglobin	1000 mg/dL
Uric acid	23.5 mg/dL
Acetaminophen	20 mg/dL
Amoxicillin	20 mg/dL
Aspirin	80 mg/dL
Gentisic acid	20 mg/dL
Salicylic Acid	20 mg/dL
Ascorbic acid	20 mg/dL
Folic acid	0.03 mg/dL
Vitamin B1	80 mg/dL
Atropine	20 mg/dL
Caffeine	20 mg/dL
Tetracycline	20 mg/dL
Ampicillin	20 mg/dL
Ibuprofen	40 mg/dL
Pregnanediol	1.5 mg/dL
β-hydroxybutyrate	2000 mg/dL

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EDTA	80 mg/dL
Ethanol	1%
Ketone	20 mg/dL
Thiophene	20 mg/dL
Benzoylecgonine	10 mg/dL
Cannabinol	10 mg/dL
Ephedrine	20 mg/dL
Phenylpropanolamine	20 mg/dL
Phenothiazine	20 mg/dL

To evaluate the effect of urine pH on the results of MissLan® Pregnancy Rapid Test, urine samples containing 0, 5 and 25 mIU/mL hCG were tested at pH values of 4, 5, 6, 7, 8 and 9. The results indicated that urine pH ranges between 4 and 9 does not affect the performance of MissLan® Pregnancy Rapid Test.

To evaluate the effect of urine density on the results of MissLan® Pregnancy Rapid Test, urine samples containing 0, 5 and 25 mIU/mL hCG were tested at density values of 1.000, 1.005, 1.010, 1.015, 1.020, 1.025, 1.030 and 1.035. The results indicated that urine with a relative density of 1.035 does not affect the performance of MissLan® Pregnancy Rapid Test.

B. Method comparison study

Method comparison with predicate device

The performance of the new device was compared to the predicate test. Urine samples were collected from 200 women presenting to test for pregnancy. Approximately half of the 200 women were suspected to be pregnant and most of them are in the early stage of less than 5 weeks. All samples were tested with candidate and predicate devices at three POC sites (3 different professionals using the candidate device and 1 professional using the predicate device at each site). The same samples were tested on both format by different operators.

The results are summarized in the table below.

	Predicate device
Candidate device	Positive	Negative	Total
Strip Device	Positive	101	0	101
	Negative	0	99	99
	Total	101	99	200

	Predicate device
Candidate device	Positive	Negative	Total
Midstream Device	52	0	52
In-stream method	0	48	48

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	Total	52	48	100
	Predicate device
Candidate device	Positive	Negative	Total
Midstream DeviceDip method	Positive	49	0	49
	Negative	0	51	51
	Total	49	51	100

The conformity between MissLan® Pregnancy Rapid Test and the predicate device is 100%.

C. Lay person study

First study:

200 women's individual pregnancy status was self-tested. Individuals with varying educational and occupational backgrounds from three sites were chosen for the study. Each subject tested her own urine sample using the device according to the package insert and provided a sample for professional testing.

The results are summarized in the table below.

Strip Device

Strip format	Professional
	Positive	Negative	Total
Layperson	Positive	52	0	52
	Negative	0	48	48
	Total	52	48	100

Midstream Device

	Professional
Midstream format(in-stream method)		Positive	Negative	Total
Layperson	Positive	26	0	26
	Negative	0	24	24
	Total	26	24	50

Midstream format(dip method)		Professional
		Positive	Negative	Total
Layperson	Positive	23	0	23
	Negative	0	27	27
	Total	23	27	50

From the above tables, the lay person results showed 100% positive and 100% negative conformity with the professional results.

Second study:

200 women's individual pregnancy status was self-tested. Negative urine sample pools were spiked with 5 mIU/mL hCG and 25 mIU/mL hCG. All aliquots were

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blind labeled by the person who prepared the samples and didn't take part in the sample testing. 100 laypersons tested the 5 mIU/mL hCG aliquots and 100 laypersons tested the 25 mIU/mL hCG aliquots. Each testing site had a study administrator to observe or monitor the studies by laypersons without providing assistance to the participants.

Summary

hCG Concentration(mIU/mL)	Lay person result		The percentage ofcorrect results (%)
	No. ofPositive	No. ofNegative
5	0	100	100%
25	100	0	100%

Each lay person was given a questionnaire to assess the readability of the labeling. The results of the questionnaire reflected that the consumers found the test easy to use and that they did not have trouble understanding the labeling and interpreting the results.

11. Conclusion

Based on the test principle and performance characteristics of the device including precision, cut-off, interference, specificity, method comparison and lay-user studies of the devices, it's concluded that MissLan® Pregnancy Rapid Test (Strip) and MissLan® Pregnancy Rapid Test (Midstream) are substantially equivalent to the predicate.

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.