MissLan™ Digital Pregnancy Rapid Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in 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™ Digital Pregnancy Rapid Test is used for in vitro qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, and is designed to be tested in dip or midstream mode. The test device consists of a single test strip assembled in a plastic housing, with an absorbent tip. The device is in a ready-to-use format.

AI/ML Overview

The provided document details the performance characteristics of the MissLan™ Digital Pregnancy Rapid Test, which is a qualitative test for human chorionic gonadotropin (hCG) in urine.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly list "acceptance criteria" for each performance metric with quantitative targets. Instead, it presents the results of various analytical and clinical studies, implying that the observed performance meets the requirements for demonstrating substantial equivalence to the predicate device.

However, we can infer the key performance metrics and the achieved results from the "Performance Characteristics" section. For qualitative pregnancy tests, crucial performance indicators include sensitivity (detection limit), specificity (absence of false positives), reproducibility, absence of hook effect, and agreement with predicate devices/professional results.

Inferred Acceptance Criteria and Reported Device Performance:

Performance Characteristic	Acceptance Criteria (Inferred)	Reported Device Performance
Analytical Sensitivity	Achieve 100% positive detection at the claimed sensitivity (25 mIU/mL hCG) and 100% negative detection at concentrations below the critical cutoff. Ensure consistent detection across multiple operators and lots.	- 25 mIU/mL hCG: 100% positive for both midstream and dip testing across all 3 operators and 3 lots (total 150 positive results for each method, 300 total).- 0 mIU/mL hCG: 100% negative for both midstream and dip testing across all 3 operators and 3 lots (total 150 negative for each method, 300 total).- 12.5 mIU/mL hCG: 100% negative for both midstream and dip testing across all 3 operators and 3 lots (total 150 negative for each method, 300 total).- Overall Sensitivity (for both methods combined): Demonstrated to be 25 mIU/mL.- Reproducibility: Exhibited reproducible results across operators and lots.
Specificity	No false positive results should be observed from healthy non-pregnant individuals across various age groups. No significant cross-reactivity with structurally similar hormones (e.g., hLH, hFSH, hTSH) or hCG ß-core fragment.	- Non-pregnant healthy females: 300 urine samples from healthy, non-pregnant females across pre-menopausal, peri-menopausal, and post-menopausal groups (100 per group) showed no false positive results for both dip and midstream testing.- Cross-reactivity: No cross-reactivity was observed with 500 mIU/mL hLH, 1000 mIU/mL hFSH, or 1000 uIU/mL hTSH.- hCG ß-core fragment: Performance not affected by hCG ß-core fragment concentrations up to 500,000 pmol/L.
Hook Effect	No false negative results at very high concentrations of hCG.	No hook effect observed at hCG concentrations up to 500,000 mIU/mL (all tested concentrations from 6,250 mIU/mL to 500,000 mIU/mL gave a positive result).
Interference	Performance should not be affected by common interfering substances, urine pH, or urine density.	- Interfering substances: No interference effect observed for 25 listed substances (e.g., Glucose, Albumin, Hemoglobin, Acetaminophen, Aspirin, Ibuprofen, Ethanol, etc.) at specified concentrations.- Urine pH: Performance not affected by urine pH values between 4 and 9.- Urine Density: Performance not affected by urine density values between 1.000 and 1.035.
Method Comparison	High conformity (ideally 100%) with a legally marketed predicate device.	- Midstream Method: 100% concordance (55 positive, 45 negative) with the predicate device (n=100).- Dip Method: 100% concordance (47 positive, 53 negative) with the predicate device (n=100).- Overall Conformity: 100% between MissLan™ and the predicate device.
Lay Person Study	High agreement between lay user results and professional results. Easy to use and interpret.	- First Study (Self-Testing): 100% conformity (midstream: 55 positive, 45 negative; dip: 47 positive, 53 negative) between layperson results and professional results (for 200 women).- Second Study (Spiked Samples): 100% correct results for 5 mIU/mL (100 negative) and 25 mIU/mL (100 positive) hCG samples tested by laypersons.- Questionnaire: Consumers found the test easy to use and had no trouble understanding labeling and interpreting results.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Analytical Performance (Sensitivity/Reproducibility):
- Sample Size: For each hCG concentration (0, 12.5, 15, 18.75, 22.5, 25, 50, 100, 200 mIU/mL):
  - 10 replicates per day for 5 days = 50 replicates per operator per lot.
  - 3 operators for each sample concentration.
  - 3 device lots.
  - Total tests per hCG concentration: 50 (replicates) * 3 (operators) * 3 (lots) = 450 tests.
  - Total tests for all concentrations: 450 * 9 = 4050 tests across all concentrations, operators, and lots.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It implies a controlled laboratory setting (analytical performance).
Specificity (Non-pregnant females):
- Sample Size: 300 urine samples (100 from pre-menopausal, 100 peri-menopausal, 100 post-menopausal).
- Data Provenance: Not specified regarding country or retrospective/prospective.
Method Comparison Study:
- Sample Size: 200 urine samples from women presenting to test for pregnancy (approximately half suspected pregnant, most in early stage < 5 weeks).
- Data Provenance: Conducted at "three POC sites." Not specified regarding country or retrospective/prospective. The description "samples were collected from... women presenting to test for pregnancy" suggests prospective collection for the study.
Lay Person Study (First Study):
- Sample Size: 200 women.
- Data Provenance: Individuals with varying educational and occupational backgrounds from "three sites." Not specified regarding country or retrospective/prospective. This was a self-testing study.
Lay Person Study (Second Study):
- Sample Size: 200 laypersons (100 tested 5 mIU/mL hCG aliquots, 100 tested 25 mIU/mL hCG aliquots).
- Data Provenance: Not specified regarding country or retrospective/prospective. Samples were laboratory-prepared spiked pools, blind labeled.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Analytical Performance: The ground truth for spiked samples was established by the known concentrations of hCG added to negative urine. There were no "experts" establishing ground truth in the traditional sense for these tests.
Specificity (Non-pregnant females): Ground truth was established by the fact that the individuals were "healthy, non-pregnant female." No expert adjudication mentioned.
Method Comparative Study: The comparator device (predicate device) and "professional" testing served as a form of ground truth for comparison. "Three POC sites (3 different professionals using the candidate device and 1 professional using the predicate device at each site)" were involved. The qualifications of these professionals are not specified beyond being "professionals."
Lay Person Study (First Study): "Professional testing" served as the ground truth. Qualifications of professionals are not specified.
Lay Person Study (Second Study): The ground truth was the known concentration of hCG in the laboratory-prepared spiked samples (0 mIU/mL, 5 mIU/mL, 25 mIU/mL hCG). "Professionals" also tested these samples for comparison, but the inherent ground truth was the known spike concentration.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Analytical Performance & Specificity: None, as ground truth was established by known concentrations or clinical status.
Method Comparison Study: "Professional" testing results and predicate device results were used for comparison. The document does not describe an adjudication method for discrepancies between these, but rather implies they served as the reference for the candidate device's performance.
Lay Person Studies: "Professional results" served as the reference for the self-tested samples. No specific adjudication method (like 2+1 or 3+1) is described. In the second lay person study, the known spike concentration was the definitive ground truth.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is a study for a digital pregnancy rapid test, not an AI-assisted diagnostic imaging system for human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not applicable and was not reported. The device uses "light reflection for the detection" and displays results on an LCD screen, not requiring human interpretation of complex images.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is a rapid diagnostic test that provides a digital readout. Its performance, as described in the Analytical Performance section, is essentially "standalone" in that it produces a result based on its internal mechanism. While a direct "algorithm only" performance study in the context of complex software algorithms isn't explicitly named, the core functional performance data (sensitivity, specificity, interference, hook effect) represents the device's inherent capability to detect hCG. The "human-in-the-loop" aspect is the user collecting and applying the urine sample, then reading the digital display, not interpreting a complex output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Known Spiked Concentrations: For analytical sensitivity, hook effect, cross-reactivity, and interfering substance studies, the ground truth was established by precisely preparing urine samples with known concentrations of hCG or other substances. This is a highly controlled laboratory method.
Clinical Status/Predetermined Criteria: For specificity studies, the ground truth was the enrollment of "healthy, non-pregnant female" volunteers.
Professional Reference/Predicate Device: For method comparison and lay person studies, the results obtained by "professionals" or the legally marketed "predicate device" served as the comparative ground truth.

8. The sample size for the training set

This document describes a 510(k) submission for a rapid diagnostic test kit, not a machine learning model that requires a "training set" in the computational sense. The device is based on a lateral flow immunoassay with an optical detection system. Therefore, the concept of a "training set" for an AI algorithm is not applicable to this type of device.

9. How the ground truth for the training set was established

As explained in point 8, the product is a rapid diagnostic test kit, not a machine learning model. Thus, there is no training set and consequently, no method for establishing ground truth for a training set in this context.

Summary

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November 30, 2022

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

Re: K222305

Trade/Device Name: MissLan™ Digital Pregnancy Rapid Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (hCG) Test System Regulatory Class: Class II Product Code: LCX Dated: July 31, 2022 Received: August 2, 2022

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 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

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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 -S Caposino -S Date: 2022.11.30
17:02:33 -05'00'

Paula Caposino, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222305

Device Name MissLanTM Digital Pregnancy Rapid Test

Indications for Use (Describe)

Only for use outside the body. 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)

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510(k) SUMMARY K22305

1.	Date:	November 29, 2022
2.	Submitter:	Guangzhou Decheng Biotechnology Co., Ltd.Building 2, No. 68, 1st Nanxiang Road, ScienceCity, Huangpu District, 510000 Guangzhou,Guangdong, 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:Classification:Product Code:CFR:	MissLan™ Digital Pregnancy Rapid TestClass IILCX862.1155
5.	Predicate Devices:	Preview® Digital Pregnancy Test (K173229)

6. Intended Use

Only for use outside the body. For over the counter use.

7. Device Description

8. Substantial Equivalence Information

Similarities
Item	Candidate device	Predicate device

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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
Target user	Over the counter use	Over the counter use
Sample application	Midstream and dipmethods	Midstream and dip methods
Readout	Digital/LCD screen	Digital/LCD screen
Differences
Item	Device	Predicate
Appearance	155.5 x 21.5 x 14.5 mm	150 x 25 x 15 mm

9. Test Principle

MissLan™ Digital Pregnancy Rapid Test uses lateral flow immunoassay and light reflection for the detection of the HCG in urine specimens. The test would detect the light intensity by using the LED as the light source. After that, the result can be displayed on the display screen.

10. Performance Characteristics

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 by both dip and midstream methods in 10 replicates per day for 5 days for each device lot. Total of three device lots were tested. Tests were performed by three different operators for each sample concentration. The results are summarized in the table below:

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	23	27	24	26	24	26	71	79	47%	53%
18.75	12	38	11	39	11	39	34	116	23%	77%

Midstream Testing

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22.5	45	45	44	134	11%	89%
25	50	50	50	150	0%	100%
50	50	50	50	150	0%	100%
100	50	50	50	150	0%	100%
200	50	50	50	150	0%	100%

Dip Testing

hCGConcentration	Operator1		Operator2		Operator3		Totalresult		%Negative	%Positive
(mIU/mL)	-	+	-	+	-	+	-	+
0	50	0	50	0	50	0	150	0	100%	0%
12.5	50	0	50	0	50	0	150	0	100%	0%
15	24	26	24	26	25	25	73	77	49%	51%
18.75	12	38	11	39	12	38	35	115	23%	77%
22.5	4	46	5	45	5	45	14	136	9%	91%
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%

Overall Testing

hCGConcentration(mIU/mL)	Lot 1		Lot 2		Lot 3		Totalresult		%Negative	%Positive
	-	+	-	+	-	+	-	+
0	100	0	100	0	100	0	300	0	100%	0%
12.5	100	0	100	0	100	0	300	0	100%	0%
15	47	53	48	52	49	51	144	156	48%	52%
18.75	24	76	22	78	23	77	69	231	23%	77%
22.5	9	91	10	90	11	89	30	270	10%	90%
25	0	100	0	100	0	100	0	300	0%	100%
50	0	100	0	100	0	100	0	300	0%	100%
100	0	100	0	100	0	100	0	300	0%	100%
200	0	100	0	100	0	100	0	300	0%	100%

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

b. Linearity/assay reportable range:

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

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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™ Digital 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 of products in sealed foil pouch are currently stable for 24 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, 300 urine samples were collected from healthy, nonpregnant female in pre-menopausal (ages 18~~40 years old), peri-menopausal (41~~55 years old) and post-menopausal (>55 years old) groups. 100 people for each age group. Both dip and midstream testing are evaluated. 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 uIU/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™ Digital 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™ Digital 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

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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
ẞ-hydroxybutyrate	2000 mg/dL
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™ Digital 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™ Digital Pregnancy Rapid Test.

To evaluate the effect of urine density on the results of MissLan™ Digital 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 1.000 to 1.035 does not affect the performance of MissLan™ Digital 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

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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).

	Midstream method	Predicate device
Candidate device		Positive	Negative	Total
	Positive	55	0	55
	Negative	0	45	45
	Total	55	45	100

Summary midstream testing results

	Predicate device
Dip method	Positive	Negative	Total
Candidate device	Positive	47	0	47
	Negative	0	53	53
	Total	47	53	100

Summary dip testing results

The conformity between MissLan™ Digital Pregnancy Rapid Test (midstream method / dip method) 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. Summary

Midstream method	Professional
	Positive	Negative	Total
Layperson	Positive	55	0	55
	Negative	0	45	45
	Total	55	45	100

Dip method		Professional
	Positive	Negative	Total
Layperson	Positive	47	0	47
	Negative	0	53	53
	Total	47	53	100

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

Second study:

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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 blind labeled by the person who prepared the samples and didn't take part in the sample testing. Both laypersons and professionals use dip method to test the above samples. 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

hCGConcentration(mIU/mL)	Lay person result		Professional result		The percentage ofcorrect results (%)
	No. ofPositive	No. ofNegative	No. ofPositive	No. ofNegative
5	0	100	0	100	100%
25	100	0	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 device, it's concluded that MissLan M Digital Pregnancy Rapid Test is 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.