ACESO Early Pregnancy Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, 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.

Important note regarding positive results:

Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare provider, especially when making decisions about future medical care.

This device is intended for home-use only.

Device Description

ACESO Early Pregnancy 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 is a 510(k) summary for the ACESO Early Pregnancy Test, a qualitative human chorionic gonadotropin (hCG) test system. It details the device's performance characteristics and studies conducted to demonstrate its substantial equivalence to a legally marketed predicate device.

Here's an analysis of the provided information, framed around acceptance criteria and the study that proves the device meets them:

Device: ACESO Early Pregnancy Test

Intended Use: Qualitative detection of human chorionic gonadotropin (hCG) in urine, 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). Intended for home use only.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" in a separate table, but rather presents performance data that implicitly serves as the proof for meeting certain thresholds. Based on the studies performed, the following can be inferred as intended performance and the results obtained:

Performance Characteristic	Acceptance Criteria (Inferred)	Reported Device Performance
Analytical Sensitivity (Limit of Detection)	Reproducible detection of 10 mIU/mL hCG.	10 mIU/mL. Both dip and midstream testing showed 100% positive results for 10 mIU/mL and higher concentrations of hCG across 3 lots and 3 operators. For 8 mIU/mL, 95% (dip) and 97% (midstream) positive detection was observed.
Precision/Reproducibility	Consistent results across different lots, operators, and replicates.	Reproducible results exhibited. For 10 mIU/mL and above, 100% positive agreement was observed across 3 lots, 10 replicates for 10 days, tested by 3 operators.
Hook Effect	No hook effect up to high hCG concentrations.	No hook effect observed up to 500,000 mIU/mL. All tested concentrations (up to 500,000 mIU/mL) gave a positive result.
Specificity (Cross-reactivity, pH, Density, Interfering Substances)	No false positives from non-pregnant females. No interference from common cross-reactants or interfering substances within specified physiological ranges.	Specificity (Non-pregnant females): 100% specificity (No false positives) observed in 300 urine samples from healthy non-pregnant females across pre-, peri-, and post-menopausal groups. Cross-reactivity: No cross-reactivity observed with 500 mIU/mL hLH, 1000 mIU/mL hFSH, 1000 uIU/mL hTSH, or hCG ß-core fragment up to 500,000 pmol/L. Interfering substances: No interference observed from 20 listed substances (e.g., acetaminophen, aspirin, caffeine, glucose, hemoglobin) at specified concentrations. Urine pH: No effect on performance for urine pH between 4 and 9. Urine Density: No effect on performance for urine density up to 1.035.
Method Comparison (vs. Predicate Device)	100% conformity with the predicate device.	100% conformity. In a study of 100 urine samples from women presenting for pregnancy testing, the ACESO device showed 100% positive and 100% negative agreement with the predicate device for both dip and midstream testing.
Lay Person Study (Usability and Interpretation)	High conformity (e.g., >95%) between lay person results and professional/expected results, and high user comprehension.	High Conformity & User Comprehension. Self-testing by 100 women showed 100% positive and 100% negative conformity with professional results for clinical samples. For spiked samples, agreements were: 100% at 3 mIU/mL, 97% at 5 mIU/mL, 99% at 8 mIU/mL, and 100% at 10 mIU/mL. Questionnaire results reflected consumers found the test easy to use and understood labeling/interpretation.
Early Pregnancy Detection (Clinical Performance)	Detect hCG as early as 5 days before expected period, reaching 100% detection on/around the expected menstrual period (EMP).	76.9% positive hCG detected 5 days before EMP. 100% positive hCG detected from 3 days before EMP through EMP+1.

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

Analytical Performance (Precision/Sensitivity):
- Sample Size: For each hCG concentration (0, 3, 5, 8, 10, 15, 25, 50 mIU/mL), 10 replicates were tested per day for 10 days for each of 3 device lots. This totals 10 * 10 * 3 = 300 tests per concentration, for a grand total of 8 concentrations * 300 tests/concentration = 2400 tests for each testing method (dip and midstream).
- Data Provenance: Negative female urine was spiked with hCG standard (Traceable to the 5th WHO). This is prospective, laboratory-controlled spiking for analytical validation. The document does not specify the country of origin of the source urine, but it's likely from a lab collection.
Specificity (Non-pregnant females):
- Sample Size: 300 urine samples.
- Data Provenance: Collected from healthy, non-pregnant females (100 each from pre-menopausal, peri-menopausal, and post-menopausal groups). This is prospective, clinical sample collection. No country of origin is specified.
Hook Effect Test:
- Sample Size: Not specified in terms of number of individual tests, but varying hCG concentrations were spiked into negative urine samples.
- Data Provenance: Laboratory-controlled spiking.
Method Comparison Study:
- Sample Size: 100 urine samples.
- Data Provenance: Collected from women presenting to test for pregnancy, with approximately half suspected of early pregnancy (<5 weeks). This is prospective, clinical sample collection. Not country of origin is specified, but it took place at "three POC sites."
Lay Person Study:
- Sample Size: 100 women/lay persons.
- Data Provenance:
  - Clinical Samples: Urine samples from 100 women whose individual pregnancy status was self-tested. This is prospective, involving self-collection and self-testing.
  - Spiked Samples: Urine samples prepared with hCG at specific concentrations (3, 5, 8, 10 mIU/mL) spiked into negative pooled urine. This is prospective, laboratory-controlled spiking for assessing interpretation accuracy.
- Data Provenance/Origin: Individuals with varying educational and occupational backgrounds from "three sites." No country of origin is specified.
Early Pregnancy Test Study:
- Sample Size: 650 urine samples from 65 pregnant women (65 characterized cycle segments).
- Data Provenance: Collected from pregnant women. Samples were masked and randomized, indicating a controlled, prospective clinical study. No country of origin is specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Analytical Performance: Ground truth was established by precise laboratory spiking of hCG standard (Traceable to the 5th WHO) at known concentrations. This does not involve human experts establishing ground truth in the traditional sense, but rather relies on the accuracy of the hCG standard and laboratory controls. Three different operators performed the tests, contributing to reproducibility data, but not establishing ground truth.
Method Comparison Study: "Professional testing" or "professional results" are mentioned, suggesting lab or medical professionals determined the ground truth using the predicate device. The document does not specify the number or qualifications of these "professionals."
Lay Person Study: "Professional testing" is mentioned as the comparator for lay person results. Again, the number and qualifications of these professionals are not specified.
Early Pregnancy Test Study: The study mentions "65 characterized cycle segments of conceptive cycles were collected from 65 pregnant women." This implies clinical characterization of pregnancy status (e.g., through blood tests, clinical examination, LMP), which serves as the ground truth. The number and qualifications of the clinicians establishing this "characterized" status are not specified, but it presumes standard medical practice.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth in any of the studies.

For analytical studies, ground truth is based on spiked concentrations.
For clinical studies (method comparison, lay person, early pregnancy), ground truth seems to be derived from a "professional result" or "characterized cycle segments," implying a single objective determination or standard clinical practice rather than a multi-reader adjudication process.

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

No, an MRMC comparative effectiveness study was not done in the context of this 510(k) summary. This type of study typically assesses the improvement in human reader performance (e.g., radiologists interpreting images) with AI assistance versus unaided reading. The ACESO Early Pregnancy Test is a qualitative in-vitro diagnostic test, not an imaging AI device that assists human readers.

The closest analogue is the "Lay Person Study," which assesses user performance with the device instructions, comparing their interpretation to professional results. This is a usability and interpretation study, not an MRMC study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The ACESO Early Pregnancy Test is a rapid chromatographic immunoassay (a physical test strip), not a software algorithm. Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study does not apply directly. The "analytical performance" section (precision, sensitivity, specificity) effectively demonstrates the device's inherent performance characteristics independent of human interpretation variability, which is then assessed in the "lay person study."

7. The Type of Ground Truth Used:

Analytical Performance: Laboratory-spiked concentrations of hCG (traceable to WHO International Standard). This is akin to a reference standard.
Specificity (Cross-reactivity, pH, Density, Interfering Substances): Laboratory-spiked concentrations of interfering substances or physical manipulation of urine properties, combined with "negative urine samples" for specificity. This uses reference standards and known clinical states (non-pregnant females).
Method Comparison Study: Results from a legally marketed predicate device ("Wondfo One Step HCG Urine Pregnancy Test").
Lay Person Study: "Professional results" (likely laboratory testing or trained personnel reading the device) for clinical samples, and laboratory-spiked concentrations for test samples.
Early Pregnancy Test Study: "Characterized cycle segments of conceptive cycles" collected from "65 pregnant women." This implies clinical diagnosis/outcomes data (confirmed pregnancy status relative to menstrual cycle).

8. The Sample Size for the Training Set

The document describes performance studies for the ACESO Early Pregnancy Test, which is a physical immunoassay device, not a machine learning or AI model. Therefore, the concept of a "training set" for an algorithm is not applicable here. The manufacturing process and quality control would be the "training" equivalent in terms of ensuring consistent device performance.

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

As noted above, there is no "training set" in the context of an AI/ML algorithm for this physical device. The ground truth for validating the device's performance (which is analogous to testing a trained model) is described in point 7.

Summary

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April 5, 2024

Aceso Laboratories, Inc. % Joe Shia Director LSI International Inc 504 E Diamond Ave., Suite H Gaithersburg, Maryland 20877

Re: K234152

Trade/Device Name: ACESO Early Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (HCG) Test System Regulatory Class: Class II Product Code: LCX Dated: February 22, 2024 Received: February 22, 2024

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 (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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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,

Paula V. Caposino -S

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

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Indications for Use

510(k) Number (if known) K234152

Device Name ACESO Early Pregnancy Test

Indications for Use (Describe)

Important note regarding positive results:

This device is intended for home-use only.

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 K234152

1.	Date:	March 22, 2024
2.	Submitter:	Aceso Laboratories, Inc.14020 Central AvenueSuite 520Chino, CA 91710
3.	Contact person:	Joe ShiaLSI International Inc.504 East Diamond Ave., Suite HGaithersburg, MD 20877Telephone: 240-505-7880Fax: 301-916-6213Email: shiajl@yahoo.com
4.	Device Name:	ACESO Early Pregnancy Test
	Classification:	Class II
	Product Code:	LCX
	CFR:	862.1155
5.	Predicate Devices:	Wondfo One Step HCG Urine Pregnancy TestMidstream, Wondfo One Step HCG Urine PregnancyTest Strip, Wondfo One Step HCG Urine Pregnancy TesCassette, K150022

6. Intended Use

Important note regarding positive results:

This device is intended for home-use only.

Device Description 7.

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Similarities
Item	Candidate device	Predicate device
Intended use	A rapid chromatographicimmunoassay for thequalitative detection ofhuman chorionicgonadotropin (hCG) inurine, as an aid in earlydetection of pregnancy, insome cases as early as five(5) days before the expectedperiod, i.e., as early as six(6) days before the day ofthe missed period.	Same
Specimen	Urine	Urine
Assay technical	Immunochromatographicassay	Immunochromatographicassay
Sensitivity	10 mIU/mL	10 mIU/mL
Results	Qualitative	Qualitative
Target user	Over the counter use	Over the counter use
Format	Midstream	Strip, cassette, midstream
Differences
Item	Device	Predicate
Time to result	3-10 minutes	5 minutes

Substantial Equivalence Information 8.

9. Test Principle

ACESO Early Pregnancy Test is a lateral flow chromatographic immunoassay. When the absorbent end is immersed into a sample, the sample is absorbed into the device by capillary action and mixes with the antibody-dye conjugate (mouse anti-beta HCG monoclonal antibody), flowing across the pre-coated (Goat anti HCG polyclonal antibody) membrane. During the test procedures, hCG in the urine specimen reacts with the dye conjugate and forms a complex. The complex migrates along the membrane to the hCG antibody line (T), and remains captured in the T line. As a result a red colored band develops in the T line, indicating a positive result. If there is no hCG in the urine, there is no red band in the test zone, indicating a negative result. The Control line should develop in the control zone

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regardless of the test result.

10. Performance Characteristics

A. Analytical nerformance

a. Precision/Reproducibility/Sensitivity

Negative female urine was spiked with hCG standard (Traceable to the 5th WHO) to hCG concentrations of 0, 3, 5, 8, 10, 15, 25 and 50 mIU/mL. Each sample was tested by both dip and midstream methods in 10 replicates per day for 10 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)	Lot 1		Lot 2		Lot 3		Totalresult		%Negative	%Positive
	-	+	-	+	-	+	-	+
0	50	0	50	0	50	0	150	0	100%	0%
3	50	0	50	0	50	0	150	0	100%	0%
5	24	26	23	27	27	23	74	76	49%	51%
8	3	47	2	48	2	48	7	143	5%	95%
10	0	50	0	50	0	50	0	150	0%	100%
15	0	50	0	50	0	50	0	150	0%	100%
25	0	50	0	50	0	50	0	150	0%	100%
50	0	50	0	50	0	50	0	150	0%	100%

Midstream Testing

Dip Testing

hCGConcentration(mIU/mL)	Lot 1		Lot 2		Lot 3		Total result		% Negative	% Positive
	-	+	-	+	-	+	-	+
0	50	0	50	0	50	0	150	0	100%	0%
3	50	0	50	0	50	0	150	0	100%	0%
5	26	24	24	26	26	24	76	74	51%	49%
8	2	48	1	49	2	48	5	145	3%	97%
10	0	50	0	50	0	50	0	150	0%	100%
15	0	50	0	50	0	50	0	150	0%	100%
25	0	50	0	50	0	50	0	150	0%	100%
50	0	50	0	50	0	50	0	150	0%	100%

ACESO Early Pregnancy Test exhibited reproducible results. Based on the above results, the sensitivity of ACESO Early Pregnancy Test is demonstrated to be 10 mIU/mL.

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b. Linearity/assay reportable range:

Linearity is not applicable since this is a qualitative test.

c. 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.

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

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

Stability:

Products in sealed foil pouch are stable for 24 months at 35.6-86°F, based on the real time stability study.

e. 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, 3 and 10 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 3 mIU/mL hCG) and positive urine samples (10 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 ACESO Early Pregnancy Test is not affected by hCG ß-core fragment concentrations up to 500,000 pmol/L.

f. Interfering substance

To evaluate potential interferers with ACESO Early Pregnancy Test, urine samples containing 0, 3 and 10 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
-----------	---------------

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Acetaminophen	20 mg/dL
Acetylsalicylic	20 mg/dL
Ascorbic acid	20 mg/dL
Atropine	20 mg/dL
Caffeine	20 mg/dL
Gentisic acid	20 mg/dL
Glucose	2 g/dL
Hemoglobin	20 mg/dL
Tetracycline	20 mg/dL
Ampicillin	20 mg/dL
Albumin	20 mg/dL
ẞ-hydroxybutyrate	2000 mg/dL
Ephedrine	20 mg/dL
Phenylpropanolamine	20 mg/dL
Phenothiazine	20 mg/dL
EDTA	80 mg/dL
Salicyclic Acid	20 mg/dL
Benzoylecgonine	10 mg/dL
Cannabinol	10 mg/dL
Codeine	6ug/dL
Ethanol	1.0%
Bilirubin	2mg/dL
Pregnanediol	1500µg/dL
Thiophene	20 mg/dL
Ketone	20 mg/dL

To evaluate the effect of urine pH on the results of ACESO Early Pregnancy Test, urine samples containing 0, 3 and 10 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 ACESO Early Pregnancy Test.

To evaluate the effect of urine density on the results of ACESO Early Pregnancy Test, urine samples containing 0, 3 and 10 mIU/mL hCG were tested at density values of 1.000, 1.009, 1.015, 1.017, 1.020, 1.022, 1.028 and 1.035. The results indicated that urine with a relative density of 1.035 does not affect the performance of ACESO Early Pregnancy 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 100 women presenting to test for pregnancy. Approximately half of the 100 women were suspected to be pregnant in the early stage of less than 5 weeks. All samples were tested with candidate and predicate

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devices at three POC sites.

Dip Testing

Pregnancy Test(ACESO)	Predicate Test(Wondfo test)		Total
	Positive (+)	Negative (-)
Positive (+)	53	0	53
Negative (-)	0	47	47
Total	53	47	100

Midstream Testing

Pregnancy Test(ACESO)	Predicate Test(Wondfo test)		Total
	Positive (+)	Negative (-)
Positive (+)	53	0	53
Negative (-)	0	47	47
Total	53	47	100

The conformity between ACESO Early Pregnancy Test and the predicate device is 100%.

C. Lay person study

100 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

	Professional Result
ACESO	Positive	Negative	Total
Lay user Result	Positive	53	0	53
	Negative	0	47	47
Total		53	47	100

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

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Spiked urine samples were also tested by lay person. Urine samples were prepared at 3mIU/ml, 5mIU/ml, 8mIU/ml and 10mIU/ml hCG concentrations by spiking hCG into negative pooled urine specimens. Each sample was aliquoted into individual containers and blind-labeled. These samples were tested by 100 lay persons.

hCGConcentrations	Lay person results		Professional results		PercentAgreement
	No. ofNegative	No. ofPositive	No. ofNegative	No. ofPositive
3 mIU/ml	100	0	100	0	100%
5 mIU/ml	52	48	49	51	97%
8 mIU/ml	4	96	5	95	99%
10mIU/ml	0	100	0	100	100%

	Lay person vs Professional

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.

D. Early Pregnancy Test Study

In this study, total 650 urine samples from 65 characterized cycle segments of conceptive cycles were collected from 65 pregnant women. All samples were masked and randomized. Each sample was tested both in-stream and dip methods using three lots of the device. The new device detected 76% positive hCG five days before the Expected Menstrual Period (EMP), and 100% positive hCG on the day of EMP. No differences were observed between different test methods. The following table is the summary of the data.

Day relative toExpected MenstrualPeriod(EMP)	Number ofPositive	Number ofNegative	Number ofTotal	% Positive
EMP-8	6	59	65	9.2%
EMP-7	16	49	65	24.6%
EMP-6	31	34	65	47.7%
EMP-5	50	15	65	76.9%
EMP-4	63	2	65	96.9%
EMP-3	65	0	65	100.0%
EMP-2	65	0	65	100.0%
EMP-1	65	0	65	100.0%
EMP	65	0	65	100.0%
EMP+1	65	0	65	100.0%

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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 ACESO Early Pregnancy 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.