The HCG Home Use Pregnancy Test Strip (Colloidal Gold) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.
The test strip is designed for over-the-counter use.
Important note regarding positive results: This test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare providers, especially when making decisions about future medical care. This device is intended for home use only.

The HCG Home Use Pregnancy Test Cassette (Colloidal Gold) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test cassette is designed for over-the-counter use.
Important note regarding positive results: This test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare providers, especially when making decisions about future medical care. This device is intended for home use only.

The HCG Home Use Pregnancy Test Midstream (Colloidal Gold) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test midstream is designed for over-the-counter use.
Important note regarding positive results: This test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare providers, especially when making decisions about future medical care. This device is intended for home use only.

Device Description

The HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold) and HCG Home Use Pregnancy Test Midstream (Colloidal Gold) utilize a combination of antibodies including a monoclonal HCG antibody to selectively detect elevated levels of HCG. The detection method is to observe the formation of colored lines when testing urine samples with test devices. The specimen migrates via capillary action along the membrane to react with the colored conjugate. Positive specimens react with the specific antibody-HCG-colored conjugate and form a red colored line at the test line region of the membrane. The absence of this colored line suggests a negative result. To serve as a procedural control, a colored line will always appear in the control line region if the test has been performed properly. HCG Pregnancy Test will be sold in three different formats: Cassette, Strip, and Midstream. The Test Strip and Midstream format contain a test device sealed in a desiccated aluminum pouch and an Instruction. The Cassette format contains a test device, a dropper, a collection container and an Instruction. The test uses two red lines to indicate results. Two distinct red lines appear in the control region (C) and test region (T) means the test is "positive". Only one red line appears in the control region(C). No apparent line in the test region (T). means the test is "negative". If No coloured line appears in the control region (C), or if there is no color band in control region (C) even there is a band in the test region (T),this means "invalid" test result.

AI/ML Overview

The provided text describes different aspects of the HCG Home Use Pregnancy Test devices, including acceptance criteria and study results. However, it does not explicitly state acceptance criteria in a dedicated section with pass/fail metrics. Instead, the performance characteristics implicitly define the acceptance criteria by demonstrating performance comparable to the predicate device and meeting expected analytical standards for a qualitative pregnancy test. I will synthesize the information to best answer your request.

1. Table of Acceptance Criteria and Reported Device Performance

Since explicit numerical acceptance criteria are not stated, I will infer them from the reported analytical performance deemed acceptable for demonstrating substantial equivalence. The predicate device's characteristics also serve as an implicit benchmark.

Acceptance Criteria (Inferred from Analytical Performance and Predicate)	Reported Device Performance (HCG Home Use Pregnancy Test)
Analytical Sensitivity: 25mIU/mL HCG detection threshold	Analytical Sensitivity: 25mIU/mL HCG
Specificity (Cross-reactivity): No interference from HCG-related hormones	Specificity (Cross-reactivity): No interference at hLH (500mIU/mL), hFSH (1000mIU/mL), hTSH (1mIU/mL)
pH Interference: No interference within physiological urine pH range	pH Interference: No interference for urine with pH 3-9
Specific Gravity Interference: No interference within physiological urine specific gravity range	Specific Gravity Interference: No interference for urine with Specific Gravity 1.000-1.035
High-Dose Hook Effect: No false negatives at high HCG concentrations	High-Dose Hook Effect: No hook effect observed up to 1,000,000 mIU/mL
HCG ß-core fragment interference: No interference	HCG ß-core fragment interference: No interference up to 1,000,000 pmol/L
Precision/Reproducibility: Consistent results across lots, days, and sites for specified HCG concentrations	Precision/Reproducibility: Excellent consistency reported across 3 lots, 5 days/2 runs per day, 3 operators, and 3 sites, with 100% detection at 25 mIU/mL and above.
Method Comparison with Predicate Device: 100% agreement between candidate and predicate devices for positive and negative samples.	Method Comparison with Predicate Device: 100% agreement (50 positive, 50 negative) across Strip, Cassette, and Midstream formats when compared to predicate.
Lay User Study: High agreement between lay user results and professional results using the predicate device.	Lay User Study: 100% agreement (50 positive, 50 negative) across Strip, Cassette, and Midstream formats when self-tested by lay users compared to professional predicate results.

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

Analytical Performance Studies (Precision, Specificity, Interference, etc.):
- Precision/Reproducibility (Intra-batch, Inter-batch): For each of the three device formats (Strip, Cassette, Midstream), 3 lots were tested. For each lot and each of the 6 HCG concentration levels (0, 12.5, 18.75, 25, 50, 100 mIU/mL), 20 samples were tested. Total samples: 3 formats * 3 lots * 6 concentrations * 20 samples = 1080 samples.
- Precision/Reproducibility (Inter-day, Inter-round): For each of the three device formats, 3 lots were tested. Over 5 days, with 2 runs per day, three operators tested blinded and randomized samples. For each lot and each of the 6 HCG concentration levels, the number of tests was (5 days * 2 runs per day * 20 samples) = 200 samples. Total samples: 3 formats * 3 lots * 6 concentrations * 200 samples = 10,800 samples.
- Inter-laboratory Precision: For each of the three device formats, tests were performed at 3 sites using 3 lots. For each site, lot, and each of the 6 HCG concentration levels, the number of tests was (3 sites * 3 lots * 20 samples (implied from the table similar to batch precision)). Total samples: 3 formats * 3 sites * 3 lots * 6 concentrations * 20 samples = 3240 samples.
- Cross-reactivity: Tested with specific concentrations of hLH, hFSH, hTSH using 3 lots of the test kits. The exact number of individual samples tested for each reactant is not specified, but it's stated "no cross reactivity was observed."
- Interference: Tested with various common substances at specific concentrations for urine samples containing 0, 10, and 25 mIU/mL hCG. Three batches of each format were tested. The exact number of individual samples tested for each substance is not specified.
- High Dose Hook Effect: 10 hCG-free specimens spiked at various high concentrations (5,000 to 1,000,000 mIU/mL) were tested on three lots of devices for each format. Total samples: 10 specimens * 8 concentrations * 3 lots * 3 formats = 720 samples.
- HCG β-core fragment: Normal non-pregnant women urine specimens (0, 10, 25 mIU/mL hCG) spiked with varying concentrations of β-core fragment. Three lots of each format were tested. The exact number of individual samples tested is not specified.
Clinical Studies (Method Comparison and Lay User Study):
- Method Comparison with Predicate Device: A total of 300 urine samples from females of childbearing age (18 to 48 years) were collected. These were split for the 3 device formats: 100 for Strip, 100 for Cassette, 100 for Midstream. Within each device format, 50 positive and 50 negative samples were used.
- Lay User Study: 300 women participated (100 for each device format: Strip, Cassette, Midstream). Each woman tested her own urine sample. Within each device format, 50 positive and 50 negative samples were used.
Data Provenance:
- Origin: The submitter is Anhui DEEPBLUE Medical Technology Co. LTD., located in Hefei, Anhui, People's Republic of China, and the designated correspondent is in Shanghai, China. The document does not explicitly state the country of origin for the samples, but given the company's location, it is highly likely the studies were conducted in China.
- Retrospective or Prospective: The studies (both analytical and clinical) appear to be prospective as samples were collected and tested as part of the study design ("samples were collected at various time throughout the day and were randomized prior to testing," "A total of 300 urine samples from females of childbearing age were collected in this clinical trial").

3. Number of Experts and Qualifications

Analytical Studies: "different operator" and "three operators" are mentioned for precision studies. No specific expert qualifications (e.g., radiologist) are provided, but these would typically be laboratory technicians or trained personnel.
Clinical Studies (Method Comparison): "laboratory professionals at 3 clinical study unit" performed testing with the candidate device. "Results reported by a laboratory professional using the predicate device" were used for comparison in the lay user study. No specific qualifications beyond "laboratory professionals" are given.
Ground Truth Establishment: The ground truth for HCG concentrations in analytical studies was established by spiking pooled negative female urine with HCG traceable to WHO 5th International Standards. For clinical studies, the predicate device results, as interpreted by laboratory professionals, served as the comparative ground truth.

4. Adjudication Method

The document does not describe any formal adjudication method (e.g., 2+1, 3+1) for resolving discrepancies in the test results. For the precision studies, multiple operators and lots were used to demonstrate consistency, but no specific adjudication process for conflicting results is mentioned. For the method comparison and lay user studies, results were compared directly, and 100% agreement was reported, implying no need for adjudication for those specific metrics.

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

No MRMC comparative effectiveness study was done. The studies compared the device's performance to established HCG concentrations (analytical) or to a predicate device (clinical), and also assessed lay user performance against professional predicate results. There is no mention of comparing human readers' performance with and without AI assistance, as these are qualitative, visually-read home-use pregnancy tests, not AI-assisted imaging devices.

6. Standalone (Algorithm Only) Performance

Yes, the device's analytical performance (sensitivity, specificity, interference, hook effect) can be considered its "standalone" performance, as it quantifies the ability of the test strip/cassette/midstream itself to detect/react to HCG in urine according to its chemical and biological design. The "method comparison" and "lay user study" sections further demonstrate the device's performance when interpreted by either professionals or lay users. Since this is a qualitative immunoassay, the "algorithm" is the biochemical reaction itself and the visual interpretation of colored lines.

7. Type of Ground Truth Used

Analytical Studies:
- For sensitivity and precision, the ground truth was known HCG concentrations in urine achieved by spiking pooled negative female urine with HCG (traceable to WHO 5th International Standard).
- For specificity and interference, the ground truth involved known concentrations of potential interfering substances or cross-reactants.
Clinical Studies (Method Comparison and Lay User Study):
- The ground truth was established by the results of the predicate device as interpreted by laboratory professionals. This implies that the predicate device is considered the gold standard for comparison in these studies.

8. Sample Size for the Training Set

This document describes performance studies for a medical device (HCG Home Use Pregnancy Test Strip, Cassette, Midstream). These devices are rapid chromatographic immunoassays and do not involve machine learning or AI models, therefore, there is no concept of a "training set" in the context of the provided information. The studies described are for validation of the device's analytical and clinical performance.

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

As stated above, this device does not utilize a training set in the machine learning sense.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue rectangle with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Anhui DEEPBLUE Medical Technology Co. LTD. % Boyle Wang Manager Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, 200120 China

Re: K240242

Trade/Device Name: HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold). Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin Regulatory Class: Class II Product Code: LCX

Dated: September 2, 2024 Received: September 5, 2024

Dear Boyle Wang:

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 (the 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/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.

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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

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).

Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-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-regulatory

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assistance/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,

Image /page/2/Picture/3 description: The image shows a digital signature. The signature is for Joseph A. Kotarek -S. The date of the signature is 2024.10.11, and the time is 11:00:20 -04'00'.

Joseph Kotarek, Ph.D. Branch Chief 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) K240242

Device Name

HCG Home Use Pregnancy Test Strip (Colloidal Gold) HCG Home Use Pregnancy Test Cassette (Colloidal Gold) HCG Home Use Pregnancy Test Midstream (Colloidal Gold)

Indications for Use (Describe)

The test strip is designed for over-the-counter use.

Important note regarding positive results: This test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare providers, especially when making decisions about future medical care. 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) Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

K240242

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.

A. Submitter's Information

Name:	ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD.
Address:	No.777 Jimingshan Road, High-Tech Development Zone,230088 Hefei, Anhui, PEOPLE'S REPUBLIC OF CHINA
Tel:	+86-551- 65326797
Contact:	Ms. Fengling Chen

B. Designated Submission Correspondent

Contact:	Mr. Boyle Wang
Name:	Shanghai Truthful Information Technology Co., Ltd.
Address:	Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai200120 China
Tel:	+86-21-50313932
Email:	Info@truthful.com.cn

Date prepared: Oct.11th,2024

C. Device Information

Trade/Device name:	HCG Home Use Pregnancy Test Strip (Colloidal Gold),
	HCG Home Use Pregnancy Test Cassette (Colloidal Gold),
	HCG Home Use Pregnancy Test Midstream (Colloidal Gold)
Common name:	Human Chorionic Gonadotropin (HCG) test
Product Code:	LCX: Kit, Test, Pregnancy, hCG, over the counter
Classification:	Class II
Regulation Number:	21 CFR 862.1155
Panel:	75-Clinical Chemistry

D. Predicate Device Information

Predicate Device#:

Manufacturer:	Safecare Biotech (Hangzhou) Co., Ltd.
---------------	---------------------------------------

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Trade/Device Name:	hCG Urine Test Strip
	hCG Urine Test Cassette
	hCG Urine Test Midstream
510(k) number:	K200133

E. Device Description

test is "negative". If No coloured line appears in the control region (C), or if there is no color band in control region (C) even there is a band in the test region (T),this means "invalid" test result.

F. Indication for Use Statement

The test strip is designed for over-the-counter use.

This device is intended for home use only.

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The test cassette is designed for over-the-counter use.

This device is intended for home use only.

Item	Subject Device(K240242)	Predicate Device(K200133)
Product Name	HCG Home Use Pregnancy TestStrip (Colloidal Gold),HCG Home Use Pregnancy TestCassette (Colloidal Gold),HCG Home Use Pregnancy TestMidstream (Colloidal Gold)	hCG Urine Test StriphCG Urine Test CassettehCG Urine Test Midstream
Intended Use	Aid in early detection of pregnancy	Early detection of pregnancy
Intended User	OTC use	OTC use
Sample Matrix	Urine	Same
Test Principle	Immunochromatographic assay	Immunochromatographic assay
Read time	5 minutes	3-5 minutes
Traceability	WHO International Standard 5thWHO Chorionic Gonadotrophin	Same
Format	Strip, Cassette, Midstream	Strip, Cassette, Midstream
Result	Qualitative	Qualitative
Antibodies	Monoclonal HCG-α antibody andgoat anti-mouse IgG polyclonalantibody on the nitrocellulosemem-brane with colloidal goldmarked anti-HCG-β mono-clonalantibody as an mark tracer.	Same

G. Technological Characteristic Comparison Table

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AnalyticalSensitivity	25mIU/mL	25mIU/mL
Specificity	LH at 500 mIU/mL, FSH at 1000 mIU/mL, and TSH at 1000 µIU/mL	Same
pH Interference	No interference for urine with pH 3-9	Same
Specific GravityInterference	No interference for urine with Specific Gravity 1.000-1.035	No interference for urine with Specific Gravity 1.001-1.039
High DosageHook effect	No high dosage hook effect for hCG up to 1,000,000 mIU/mL	No high dosage hook effect for hCG up to 850,000 mIU/mL

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H. Standards/Guidance Documents Referenced

Guidance for Over-the Counter (OTC) Human Chorionic Gonadotropin (hCG) 510(k)s

l. Test Principle

The HCG Home Use Pregnancy Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. It utilizes a combination of antibodies including a monoclonal HCG antibody to selectively detect elevated levels of HCG. The assay is conducted by filling the urine specimen to sample well and observing the formation of red-colored lines. The specimen migrates via capillary action along the membrane to react with the colored conjugate. Positive specimens react with the specific antibody-HCG-colored conjugate and form a red colored line at the test line region of the membrane. The absence of this red colored line suggests a negative result. To serve as a procedural control, a red colored line will always appear in the control line region if the test has been performed properly.

J. Performance Characteristics

1. Analytical performance

a) Precision/Reproducibility
a.1) Sensitivity, Intra-batch precision, Inter-batch precision

A pooled negative female urine was spiked with hCG (traceable to WHO 5th IS) to provide six urine standards with the hCG concentrations of 0,12.5,18.75,25,50,100mlU/ml. using 3 lots of each format of the candidate device were tested by different operator. The samples were blinded and randomized. The sensitivity is 25 mlU/mL hCG. The results are summarized in the tables below:

HCG concentration(mIU/mL)	Lot 1		Lot 2		Lot 3		Total result		Positive(%)	Negative(%)
	+	-	+	-	+	-	+	-
0	0	20	0	20	0	20	0	60	0	100
12.5	0	20	0	20	0	20	0	60	0	100
18.75	8	12	9	11	8	12	25	35	41.67	58.33
25	20	0	20	0	20	0	60	0	100	0
50	20	0	20	0	20	0	60	0	100	0
100	20	0	20	0	20	0	60	0	100	0

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HCG concentration(mIU/mL)	Lot 4		Lot 5		Lot 6		Total result		Positive(%)	Negative(%)
	+	-	+	-	+	-	+	-
0	0	20	0	20	0	20	0	60	0	100
12.5	0	20	0	20	0	20	0	60	0	100
18.75	9	11	8	12	8	12	25	35	41.67	58.33
25	20	0	20	0	20	0	60	0	100	0
50	20	0	20	0	20	0	60	0	100	0
100	20	0	20	0	20	0	60	0	100	0

Table a-1-2: The results of HCG Home Use Pregnancy Test Strip (Colloidal Gold)

Table a-1-3: The Results of HCG Home Use Pregnancy Test Midstream (Colloidal Gold)

HCG concentration(mIU/mL)	Lot 7		Lot 8		Lot 9		Total result		Positive(%)	Negative(%)
	+	-	+	-	+	-	+	-
0	0	20	0	20	0	20	0	60	0	100
12.5	0	20	0	20	0	20	0	60	0	100
18.75	9	11	8	12	8	12	25	35	41.67	58.33
25	20	0	20	0	20	0	60	0	100	0
50	20	0	20	0	20	0	60	0	100	0
100	20	0	20	0	20	0	60	0	100	0

a.2) Inter-day Precision and Inter-round Precision

A pooled negative female urine was spiked with hCG (traceable to WHO 5th IS) to provide six urine standards with the the hCG concentrations of 0,12.5,18.75,25,50,100mlU/ml. Over a period of 5 days, with 2 run of testing each day, three operators tested the blinded and randomized samples using 3 lots of each format of candidate device.

HCG concentration(mIU/mL)	Lot 1		Lot 2		Lot 3		Total result		Positive(%)	Negative(%)
	+	-	+	-	+	-	+	-
0	0	200	0	200	0	200	0	600	0	100
12.5	0	200	0	200	0	200	0	600	0	100
18.75	85	115	89	111	86	114	260	340	43.33	56.67
25	200	0	200	0	200	0	600	0	100	0
50	200	0	200	0	200	0	600	0	100	0
100	200	0	200	0	200	0	600	0	100	0

Table a-2-1:The Results of HCG Home Use Pregnancy Test Cassette (Colloidal Gold)

Table a-2-2:The Results of HCG Home Use Pregnancy Test Strip (Colloidal Gold)

HCG concentration(mIU/mL)	Lot 4		Lot 5		Lot 6		Total result		Positive(%)	Negative(%)
	+	-	+	-	+	-	+	-
0	0	200	0	200	0	200	0	600	0	100
12.5	0	200	0	200	0	200	0	600	0	100
18.75	87	113	87	113	88	112	262	338	43.67	56.33

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25	200	0	200	0	200	0	600	0	100	0
50	200	0	200	0	200	0	600	0	100	0
100	200	0	200	0	200	0	600	0	100	0

Table a-2-3:The Results of HCG Home Use Pregnancy Test Midstream (Colloidal Gold)

HCG concentration(mIU/mL)	Lot 7		Lot 8		Lot 9		Total result		Positive(%)	Negative(%)
	+	-	+	-	+	-	+	-
0	0	200	0	200	0	200	0	600	0	100
12.5	0	200	0	200	0	200	0	600	0	100
18.75	82	118	87	113	86	114	255	345	42.5	57.5
25	200	0	200	0	200	0	600	0	100	0
50	200	0	200	0	200	0	600	0	100	0
100	200	0	200	0	200	0	600	0	100	0

a.3) Inter-laboratory precision

A pooled negative female urine was spiked with hCG (traceable to WHO 5th IS) to provide six urine standards with the hCG concentrations of 0,12.5,18.75,25, 50, 100mlU/ml. The tests were performed on 3 sites using three lots of each format of candidate device. The samples were blinded and randomized.

HCGconcentration(mIU/mL)	Site 1(Lot 1, Lot 2,Lot3)		Site 2(Lot 1, Lot 2,Lot3)		Site 3(Lot 1, Lot 2,Lot3)		Total result		Positive(%)	Negative(%)
	+	-	+	-	+	-	+	-
0	0	300	0	300	0	300	0	900	0%	100%
12.5	0	300	0	300	0	300	0	900	0%	100%
18.75	150	150	150	150	150	150	450	450	50%	50%
25	300	0	300	0	300	0	900	0	100%	0%
50	300	0	300	0	300	0	900	0	100%	0%
100	300	0	300	0	300	0	900	0	100%	0%

Table a-3-1:The Results of HCG Home Use Pregnancy Test Cassette (Colloidal Gold)

Table a-3-2:The Results of HCG Home Use Pregnancy Test Strip (Colloidal Gold)

HCGconcentration(mIU/mL)	Site 1(Lot 4, Lot 5,Lot 6)		Site 2(Lot 4, Lot 5,Lot 6)		Site 3(Lot 4, Lot 5,Lot 6)		Total result		Positive(%)	Negative(%)
	+	-	+	-	+	-	+	-
0	0	300	0	300	0	300	0	900	0%	100%
12.5	0	300	0	300	0	300	0	900	0%	100%
18.75	150	150	150	150	140	160	440	460	48.89%	51.11%

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25	300	0	300	0	300	0	900	0	100%	0%
50	300	0	300	0	300	0	900	0	100%	0%
100	300	0	300	0	300	0	900	0	100%	0%

Table a-3-3:The Results of HCG Home Use Pregnancy Test Midstream (Colloidal Gold)

HCGconcentration(mIU/mL)	Site 1(Lot 7, Lot 8,Lot 9)		Site 2(Lot 7, Lot 8,Lot 9)		Site 3(Lot 7, Lot 8,Lot 9)		Total result		Positive(%)	Negative(%)
	+	-	+	-	+	-	+	-
0	0	300	0	300	0	300	0	900	0%	100%
12.5	0	300	0	300	0	300	0	900	0%	100%
18.75	130	170	150	150	140	160	420	480	46.67%	53.53%
25	300	0	300	0	300	0	900	0	100%	0%
50	300	0	300	0	300	0	900	0	100%	0%
100	300	0	300	0	300	0	900	0	100%	0%

b) Linearity/Assay Reportable Range

Linearity is not applicable since this is a qualitative test.

c) Traceability
The tests are calibrated against the WHO 5th International Standards for hCG.
d) Stability
A shelf-life stability test of the devices was performed in real-time and accelerated testing. The results showed that the devices were stable for 36 months when stored at 4~30°C in the sealed foil pouch.
e) Detection Limits (Sensitivity)
Precision section above. According to the results of precision data above, the sensitivity of HCG Urine Test is 25mlU/ml.
f) Analytical Specificity f.1) Cross reactivity:
Negative and positive female urine contain 12.5mlU/mL and 25 mlU/ml hCG were spiked with various concentrations of the following potential cross reactants: hLH, hFSH, and hTSH. The samples were tested using 3 lots of the test kits. No cross reactivity was observed on the HCG Pregnancy Test

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Strip/cassette/

midstream at the concentrations tested below:

Reactant	Concentration at which no significantinterference was observed
Human luteinizing hormone (hLH)	500 mIU/mL
Human follicle stimulating hormone (hFSH)	1000 mIU/mL
Human thyrotropin (hTSH)	1 mIU/mL

f.2) Interference:

To evaluate the potential interference of certain exogenous compounds, dilute each interfering substance to the required concentration and add interfering substances to female urine samples containing 0mlU/mL, 10mlU/mL and 25mIU/mL hCG to obtain the required detection samples. Three batches of each format were tested.

The results show that no interferences were observed from substance at the following concentrations for both negative and positive HCG urine samples.

Interfering Substance	Concentration at which no significantinterference was observed
Glucose	2000mg/dL
Protein	5.65mmol/L
Albumin	2000mg/dL
Bilirubin	2mg/ml
Hemoglobin	1000mg/dL
Caffeine	20mg/dL
Ascorbic acid (Vitamin C)	20mg/dL
Acetaminophen	20mg/mL
Aspirin	20mg/dL
Tetracycline	20mg/dL
Ampicillin	20mg/dL
Erythrocytes	>250/μL
Leukocyte	>500/μL
Uric acid	450mmol/L
Ketone	>80mg/dL
Ethanol	1%
Folic acid	800µg/mL
Vitamin B1	800µg/mL
β-hydroxybutyrate	2000mg/dL
EDTA	80mg/dL
Thiophene	20mg/dL
Benzoylecgonine	10mg/dL
Cannabinol	10mg/dL
Ephedrine	20mg/dL
Phenylpropanolamine	20mg/dL
Phenothiazine	20mg/dL

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Effect of urine pH:

Effect of urine pH was performed by adjusting urine samples containing 0mlU/mL, 10mlU/mL and 25mlU/mL hCG urine standard to a pH range of 3.0, 3.5,4.0,4.5,5.0,5.5,6.0,6.5,7.0,7.5,8.0, 8.5, and 9.0. The results demonstrated the subject device will continue to return a correct result when tested with a urine sample in the pH range of 3.0 - 9.0.

Effect of Urine Specific Gravity:

To test the effect of specific gravity, urine samples containing OmlU/mL, 10 mIU/mL 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. Three batches of each format were tested. The results showed the subject device will continue to return a correct result in response to changes in specific gravity within the range from 1.000 - 1.035.

High Dose Hook Effect Study

To evaluate high dose hook effect, 10 hCG-free specimens were spiked with hCG at 5,000, 10,000, 100,000, 500,000, 850,000, 850,000, 950,000 and 1,000,000 mIU/mL and were tested on three lots of devices for each format. The results demonstrated that no hook effect was observed at hCG concentration up to 1,000,000 mIU/mL.

Effect of hCG ß-core fragment:

To evaluate the effects of the hCG ß-core fragment, normal non-pregnant women urine specimens containing 0mlU/mL,10mlU/mL and 25mlU/mL hCG were spiked with the hCG ß-core fragment at concentrations of 125,000pmol/mL, 250,000pmol/mL, 500,000pmol/mL and 1,000,000pmol/mL. Three lots of each format were tested.

The data demonstrated that there is no interference when the hCG ß-core fragment was tested at a concentration of 1,000,000 pmol/L.

2. Comparison Study:

a. Method comparison with predicate device

A total of 300 urine samples from females of childbearing age were collected in this clinical trial for parallel testing. Ages of these women ranged from 18 to 48 years.

Samples were collected at various time throughout the day and were

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randomized prior to testing. Testing was performed by laboratory professionals at 3 clinical study unit. Results of the professional using the candidate device were compared to results obtained from the predicate device. Summary of results are presented in the tables below:

Candidate device	Predicate device
	Positive	Negative
Positive	50	0
Negative	0	50
Total	50	50

The results of professional method comparison (Strip)

The results of professional method comparison (Cassette)

Candidate device	Predicate device
	Positive	Negative
Positive	50	0
Negative	0	50
Total	50	50

The results of professional method comparison (Midstream, in-stream method)

Candidate device	Predicate device
	Positive	Negative
Positive	50	0
Negative	0	50
Total	50	50

b. Matrix Comparison

Not Applicable. The device is intended for urine sample only.

3.Lay User Study:

300 women's individual pregnancy status was self-tested. Individuals with varying educational and occupational backgrounds were chosen for the study. 100 lay users using test strip, 100 lay users using test cassette, 100 lay users using the test midstream (in-stream method). Each subject tested her own urine sample using the device according to the package insert and the results of their test were compared to results reported by a laboratory professional using the predicate device.

Samples were also randomized prior to testing and specimens were collected throughout the day and tested.

The results are summarized in the table below.

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Results of the lay user method comparison for the HCG Home Use Pregnancy Test Strip (Colloidal Gold)

	Candidate device		Predicate device -Professional user
		Positive	Negative
Lay users	Positive	50	0	50
	Negative	0	50	50
	Total	50	50	100

Results of the lay user method comparison for the HCG Home Use Pregnancy Test Cassette (Colloidal Gold)

Candidate device	Predicate device - Professional user		Total
	Positive	Negative
Lay users
Positive	50	0	50
Negative	0	50	50
Total	50	50	100

Results of the lay user method comparison for the HCG Home Use Pregnancy Test Midstream (Colloidal Gold) (in-stream method)

Candidate device	Predicate device -Professional user		Total
	Positive	Negative
Lay users	Positive	50	0	50
	Negative	0	50	50
Total		50	50	100

K. Conclusion

Based on the test principle and performance characteristics of the device including precision, interference, specificity, method comparison and lay-user studies of the devices, it's concluded that the subject device 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.