One Step Pregnancy Test is an over-the-counter lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. The visual test is intended for home use as an aid in early detection of pregnancy. The test is indicated for use from 4 days before the day of the expected period (5 days before the day of the missed period).

Device Description

The One Step Pregnancy Test is an over-the-counter, visual pregnancy test with sensitivity of 25mIU/mL hCG (human chorionic gonadotropin) and is indicated for use up to 4 days before the expected period (5 days before the missed period). The device eeeploys an immunochromatographic sandwich assay to detect hCG on a lateral flow test strip housed in a cassette. Following sample application using the supplied pipette, the user is required to visually interpret the results displayed as lines in a result window.

AI/ML Overview

This document describes the validation of the "One Step Pregnancy Test," an over-the-counter lateral flow immunoassay for qualitative detection of human chorionic gonadotropin (hCG) in urine.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Description	Reported Device Performance
Analytical Sensitivity	The lowest concentration of hCG at which the device reliably produces a positive result (detects pregnancy).	25 mIU/mL: The study demonstrated that at 25 mIU/mL hCG, 100% of the devices (180/180) returned a "Pregnant" result.
Analytical Specificity (Interfering Substances)	The ability of the device to correctly identify the absence of pregnancy in the presence of various potentially interfering substances (e.g., common medications, urine constituents).	No interference was observed at tested concentrations of a wide range of substances including Acetylsalicylic acid, Acetone, Albumin, Ampicillin, Ascorbic acid, Atropine, Bilirubin, Blood, Caffeine, Cannabinol, Clomiphene citrate, Cotinine, Ethanol, E3G, Glucose, Gentisic acid, Haemoglobin, Hydrochloric acid, Ibuprofen, Leukocytes, Oxytetracycline, Paracetamol, P3G, Phenylpropanolamine, Semen, Sodium hydroxide, Tetracycline, Urea, and Uric acid.
Analytical Specificity (Cross Reactants)	The ability of the device to correctly identify the absence of pregnancy in the presence of other hormones that might be structurally similar to hCG.	Specificity of ≥99% was demonstrated when tested with Follicle – Stimulating Hormone (FSH) (1000 mIU/mL), Luteinizing Hormone (LH) (500 mIU/mL), and Thyroid – Stimulating Hormone (TSH) (1mIU/mL). The performance was also not affected by high concentrations of hCG ß-core fragment.
Precision/Reproducibility	Consistency of results when tested by different operators, on different days, and with different batches of devices.	The study (180 devices from 4 batches, tested by 3 operators over 3 non-consecutive days at 8 hCG concentrations) indicated that results were not significantly affected by operator, day of testing, or batch across the tested standards. At 25 mIU/mL and above, 100% pregnant results were consistently observed across all batches.
High Dose Hook Effect	The absence of a "hook effect," where very high concentrations of the analyte can lead to a false negative result.	No hook effect was observed at tested hCG concentrations up to 1,000,000 mIU/mL.
Stability	The device maintains its performance over its claimed shelf life.	The claimed shelf life is 24 months when stored in sealed pouches at room temperature. Real-time stability studies are ongoing. (Note: This criterion is met, but the details of the study proving it are not fully described, only that it's ongoing).
Effect of Urine pH	The device's performance is robust across a physiologic range of urine pH.	The device continued to return a correct result when tested with urine samples in the pH range of 4 - 9.
Effect of Urine Specific Gravity	The device's performance is robust across a range of urine specific gravity.	The device continued to return a correct result in response to changes in specific gravity within the range from 1.000 to ≤1.035.
Agreement with Predicate Device	The device performs equivalently to a legally marketed predicate device.	100% agreement with the QUIK-CHECK™ Home Pregnancy Test when testing 150 pregnant and 150 non-pregnant urine samples.
Lay User Performance	The device can be used and interpreted correctly by intended lay users (over-the-counter use).	100% agreement between lay-user volunteer results and their clinical status with the One Step Pregnancy Test (n=120, 21 pregnant, 99 not pregnant). Also, 100% agreement between lay-user volunteer results and technician results. A separate lay user study on biobank samples (n=79, 70 pregnant, 9 not pregnant) also showed 100% agreement between volunteer results and the clinical status of the biobank sample. This demonstrates that volunteers were able to use the product following the IFU to obtain a valid result.
False-Positive Rate	The rate at which the device incorrectly identifies pregnancy in non-pregnant individuals, especially in specific demographics like peri- and post-menopausal women where hCG levels might fluctuate.	0% false positives observed (100% specificity): - Peri-menopausal (n=150) and Post-menopausal (n=150) women: 100% specificity. - Pre-menopausal (18-40 years) non-pregnant women (n=133) from the comparison study: 100% specificity.
Early Pregnancy Detection	The ability of the device to detect pregnancy accurately at various stages relative to the missed period, as claimed in the indications for use (from 4 days before the day of the expected period).	At 4 days before the expected period (-4 days relative to missed period), the device detected 91.7% of pregnancies (121/132). Performance increased closer to the missed period, reaching 100% on the day of the missed period (Day 0). This supports the claim for use from 4 days before the expected period.

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

Analytical Performance (Precision/Reproducibility/Sensitivity):
- Sample Size: 1440 devices tested (180 devices per hCG standard concentration x 8 concentrations). Each concentration had 45 devices from each of 4 batches.
- Data Provenance: Not explicitly stated, but implied to be generated in a controlled laboratory setting (likely in the UK, given the applicant's address). This was a prospective study where samples were spiked with known concentrations of hCG.
High Dose Hook Effect Study:
- Sample Size: 75 devices (5 replicates per concentration x 3 batches x 5 concentrations).
- Data Provenance: Laboratory setting, spiked samples.
Interfering Substances Study:
- Sample Size: 2 (urine standards) x Number of interfering substances (approx. 20-30 substances) x 5 devices x 3 batches. So, potentially 300-450 devices per interfering substance.
- Data Provenance: Laboratory setting, spiked samples.
Cross Reactants Study:
- Sample Size: 3 cross reactants x 2 (urine standards) x 5 devices x 3 batches = 90 devices. The hCG ß-core fragment study involved 165 devices (11 conditions x 5 devices x 3 batches).
- Data Provenance: Laboratory setting, spiked samples.
Urine pH and Specific Gravity Studies:
- Sample Size: 6 pH conditions x 2 (urine standards) x 15 devices = 180 devices for pH. 5 SG conditions x 2 (urine standards) x 15 devices = 150 devices for SG.
- Data Provenance: Laboratory setting, adjusted urine samples.
Comparison Study with Predicate Device:
- Sample Size: 300 urine samples (150 pregnant, 150 not pregnant). Each sample was tested on the subject device and the predicate device.
- Data Provenance: Not explicitly stated, but refers to "urine samples from pregnant women and not pregnant women," implying real patient samples. Retrospective (samples collected and then tested).
Early Pregnancy Detection Clinical Samples:
- Sample Size: 1197 One Step Pregnancy Test devices used. The table shows varying numbers of samples per day relative to missed period, totaling 1197.
- Data Provenance: Early pregnancy urine samples collected from days 0 to -9 relative to the day of the missed period. Implied to be real patient samples. Retrospective.
Lay User Study (Own Urine Sample):
- Sample Size: 120 volunteers (21 pregnant, 99 not pregnant). Each volunteer tested their own urine sample.
- Data Provenance: Prospective, real-world (home-use simulation). Participants were "pregnant and not pregnant women volunteers with diverse educational and professional backgrounds." The "clinical status" was the ground truth.
Lay User Study on Biobank Samples:
- Sample Size: 79 volunteers (70 pregnant, 9 not pregnant). Each volunteer tested a single biobank sample.
- Data Provenance: Prospective, using "biobank samples" with "confirmed clinical pregnancy status."
Specificity Study (False-Positive Rate - Peri/Post-menopausal):
- Sample Size: 300 urine samples (150 from peri-menopausal women, 150 from post-menopausal women).
- Data Provenance: Real patient samples from specific demographic groups. Retrospective.

3. Number of Experts and Qualifications for Ground Truth

For the Analytical Performance studies (sensitivity, specificity, precision, hook effect, pH, SG), the ground truth was established by the precise spiking of hCG to known concentrations or the verified absence of hCG in negative urine, as well as the addition of known interfering/cross-reacting substances. No human "experts" were needed for interpretation of these analytical measurements; the results were quantitative (concentration) or verified qualitative properties.
For the Comparison Study, Early Pregnancy Detection Clinical Samples, and False-Positive Rate Study (Peri/Post-menopausal), the ground truth was "clinical status" or "clinical pregnancy status." It is implied that this clinical status was established by medical professionals or standard clinical diagnostic methods. The document does not specify the number or qualifications of these experts, as the device is being compared to a clinical status rather than an expert's interpretation of an image.
For the Lay User Studies, the ground truth was the "clinical pregnancy status" of the volunteers' own urine samples or the "confirmed clinical pregnancy status" of the biobank samples. Again, the number and specific qualifications of the medical professionals establishing this clinical status are not detailed.

4. Adjudication Method for the Test Set

Adjudication, in the sense of multiple experts reviewing and reaching consensus on an image or case, is not applicable here. This is a diagnostic immunoassay that provides a binary (Pregnant/Not Pregnant) visual result.
For the analytical studies, the "ground truth" was established based on the controlled preparation of the samples (e.g., precise spiking of hCG).
For the clinical studies, results were compared against an established clinical status of the urine samples or volunteers.
In the lay user studies, volunteer interpretations were compared against their clinical status and/or technician interpretations. The document states "100% agreement" implies a direct comparison without a complex adjudication process.

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

No, an MRMC comparative effectiveness study was not done in the context of human readers improving with AI assistance. This device is a standalone over-the-counter visual test, not an AI-assisted diagnostic tool interpreted by medical professionals.
The "Lay User Study" can be considered a form of human performance evaluation, showing that lay users can correctly interpret the test without assistance, but it is not an MRMC study and does not involve AI assistance.

6. Standalone Performance

Yes, standalone performance was done. The entire analytical performance section (Precision/Reproducibility/Sensitivity, High dose hook effect, Analytical specificity, Effects of urine pH/SG) evaluates the device's performance independently of human interpretation bias. In these studies, trained technicians performed the tests, ensuring correct execution of the device's mechanism.
The comparison to the predicate device and the early pregnancy detection studies also represent the device's standalone performance in a clinical context.

7. Type of Ground Truth Used

Expert Consensus: Not applicable in the typical sense for medical image interpretation.
Pathology: Not applicable.
Outcomes Data: The "clinical pregnancy status" (e.g., pregnant or not pregnant) serves as the ultimate ground truth for the clinical and lay user studies. This is an outcome, based on medical assessment.
Spiked Samples/Known Concentrations: For analytical studies, the ground truth was the precisely known concentrations of hCG or other substances added to the urine samples.

8. Sample Size for the Training Set

Not applicable. This document describes a traditional in-vitro diagnostic (IVD) device, not an AI/Machine Learning model. Therefore, there is no "training set" in the computational sense. The device's performance is determined by its inherent chemical and physical properties, which are developed through R&D and manufacturing processes.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of medical device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box. Underneath that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 10, 2022

SPD Swiss Precision Diagnostics GmbH % Kamila Przedmojska Senior Regulatory Specialist - Product Lifecycle SPD Development Company Limited Priory Business Park, Stannard Way Bedford, Bedfordshire MK44 3UP United Kingdom

Re: K210341

Trade/Device Name: One Step Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (hCG) Test System Regulatory Class: Class II Product Code: LCX Dated: December 1, 2021 Received: December 10, 2021

Dear Kamila Przedmojska:

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.

{1}------------------------------------------------

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/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,

Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K210341

Device Name One Step Pregnancy Test

Indications for Use (Describe)

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

| | Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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

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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image contains the logo for Swiss Precision Diagnostics GmbH. The logo features the letters "SPD" in a stylized font, with the letters arranged in a circular shape. The circle transitions from blue at the top to green at the bottom. To the right of the circle, the text "Swiss Precision Diagnostics GmbH" is written in a simple, sans-serif font.

510(k) Summary

A. Submitted By:	SPD Swiss Precision Diagnostics GmbH47 Route de Saint-GeorgesPetit-LancyCH-1213GenevaSwitzerlandTelephone: +41 580048741
B. Contact Person:	Kamila PrzedmojskaPrincipal Regulatory SpecialistSPD Development Company LimitedPriory Business ParkBedfordMK44 3UPUnited Kingdom
C. Date Prepared:	09 March 2022
D. Device Name:	One Step Pregnancy Test
Product Code:Common name:Classification:Regulation Description:Regulation number:510(k) number:	LCXKit, Test, Pregnancy, hCG, over the counterClass IIHuman chorionic gonadotropin (hCG) test system21CFR 862.1155K210341

K012215, QUIK-CHECK™ Home Pregnancy Test E. Predicate Device:
test

{4}------------------------------------------------

F. Indication for Use

G. Device Description

H. Substantial Equivalence Information

Predicate device name:

QUIK-CHECK™ Home Pregnancy Test

Predicate (k) number:

K012215

{5}------------------------------------------------

Comparison with predicate:

Similarities and differences between the One Step Pregnancy Test and the predicate QUIK-CHECK™ Home Pregnancy Test

Component	One Step Pregnancy Test(Proposed Device)	QUIK-CHECK™ HomePregnancy Test(Predicate Device)
Similarities
Intended Use	Over-the-counter lateral flowimmunoassay for thequalitative detection of humanchorionic gonadotropin (hCG)in urine. The visual test isintended for home use as anaid in early detection ofpregnancy.	Intended for non-professional/ over-the-counter use forthe qualitative identificationof hCG (human chorionicgonadotropin) in urine to aidin the determination ofpregnancy.
Target User	Over-the-counter use	Same
Device format	Cassette	Same
Analyte	hCG	Same
Sensitivity	25mIU/mL	Same
Test Principle	Lateral flow qualitativechromatographic immunoassaywith visual result display	Same
Sampleapplication	Sample applied as drops tosample well via suppliedpipette	Same
Time to results	3 minutes	Same
Result Display	Visual interpretation ofcoloured lines in result window	Same
Differences
Traceability	WHO 4th InternationalStandard for hCG	WHO 3rd InternationalStandard for hCG
Early Claim	Pregnancy can be detected asearly as 4 days before the dateof the expected period (5 daysbefore missed period)	Not tested for this device

{6}------------------------------------------------

I. Test Principle

The One Step Pregnancy Test is a lateral flow sandwich immunoassay employing monoclonal antibodies that are directed against the alpha and beta sub-units of hCG.

To use the test, the user collects their urine in a clean dry container and uses the supplied pipette to draw up and deposit 4 drops of urine into the sample well.

If hCG is present in the urine sample, it is bound by a conjuqated monoclonal anti α-hCG antibody forming an anti hCG-antibody-gold complex. The sample is drawn through the nitrocellulose membrane by capillary action. At the test (T) line, any hCG is bound by immobilised antiß hCG antibody forming a sandwich, immobilising gold particles as the test line. This sandwich gives rise to a coloured line. If no hCG is present in the sample, there is no binding at the test line and subsequently, no coloured line.

At the control (C) line, rabbit IgG sensitised gold particles encounter the immobilised control antibody line (goat anti-rabbit antibody). The rabbit IgG is bound at the control (C) line within the result window and a coloured line forms to show that the test has worked correctly.

At the read time the appearance of two coloured lines in the result window, the test (T) line and control (C) line, indicates a Pregnant result. The appearance of one coloured line in the result window, the control (C) line, indicates a Not Pregnant result. If there is no control (C) line, the test has not run correctly and is classed as an Invalid result.

J. Performance characteristics

1. Analytical Performance

a) Precision/Reproducibility/Sensitivity

A pooled negative urine was spiked with hCG to provide eight urine standards with the hCG concentrations of <0.5, 12.5, 15, 18, 25, 50, 100 and 200mIU/mL. The eight standards were each tested with 180 devices from four different batches. Each batch was tested by 3 operators over 3 non-consecutive days

{7}------------------------------------------------

The results of the precision and sensitivity study at each concentration of hCG are summarised in the tables below. The results demonstrated that the analytical sensitivity of the One Step Pregnancy Test is 25mIU/mL.

hCG Standard(mIU/ml)	Total (n)	Pregnant(n)	Not Pregnant(n)	PregnantResults (%)
<0.5	180	0	180	0.0
12.5	180	30	150	16.7
15	180	76	104	42.2
18	180	145	35	80.6
25	180	180	0	100.0
50	180	180	0	100.0
100	180	180	0	100.0
200	180	180	0	100.0
Total	1440	971	469	N/A

Overall Precision Results for One Step Pregnancy Test

Percentage Pregnant Results for each hCG standard by Batch

hCGStandard(mIU/ml)	CYG00011		CYG00012		CYG00013		CYG00016
	Pregnant/ NotPregnant(n)	PregnantResults (%)	Pregnant/ NotPregnant(n)	PregnantResults (%)	Pregnant/ NotPregnant(n)	PregnantResults (%)	Pregnant/ NotPregnant(n)	PregnantResults (%)
<0.5	0/45	0.0	0/45	0.0	0/45	0.0	0/45	0.0
12.5	7/38	15.6	8/37	17.8	6/39	13.3	9/36	20.0
15	16/29	35.6	22/23	48.9	19/26	42.2	19/26	42.2
18	35/10	77.8	38/7	84.4	37/8	82.2	35/10	77.8
25	45/0	100	45/0	100	45/0	100	45/0	100
50	45/0	100	45/0	100	45/0	100	45/0	100
100	45/0	100	45/0	100	45/0	100	45/0	100
200	45/0	100	45/0	100	45/0	100	45/0	100

The study indicates that the results returned by the One Step Pregnancy Test are not significantly affected by operator, day of testing or batch across the standards tested in the study. The results demonstrated that the analytical sensitivity of the One Step Pregnancy Test is 25mIU/mL.

b) Linearity/assay reportable range:

{8}------------------------------------------------

Not applicable. This is a qualitative device.

c) High dose hook effect study:

Negative pooled urine was spiked with hCG to concentrations of <0.5, 25, 250000, 500000, 100000mIU/mL and tested with 5 replicates per each of 3 batches. No hook effect was observed at tested concentrations.

d) Traceability

The devices are calibrated aqainst the WHO 4th International Standard for Chorionic Gonadotropin (hCG) (NIBSC code 75/589).

e) Stability

The claimed shelf life of the device stored in the sealed pouches at room temperature is 24 months. Real time stability studies are ongoing.

f) Detection limit (sensitivity)

See Precision / Reproducibility / Sensitivity section

g) Analytical specificity

Structure not-related compounds

Interfering substances

The One Step Pregnancy Test devices were tested with potentially interfering substances. Each interfering substance was spiked into nonpregnant pooled urine (<0.5mIU/mL) and 25mIU/mL hCG urine standards.

Each condition was tested with 5 devices from each of three batches for each of the two urine standards. No interference effect was observed at the tested concentration shown in table below:

Interfering Substance	Concentration
Acetylsalicylic acid	1.0mg/mL
Acetone	1.0mg/mL(0.125% v/v)
Albumin	5mg/mL
Interfering Substance	Concentration
Ampicillin	200µg/mL
Ascorbic acid	150µg/mL
Atropine	200µg/mL
Bilirubin	200µg/mL
Blood	0.3% v/v
Caffeine	1.2mg/mL
Cannabinol	100µg/mL
Clomiphene citrate	24µg/mL
Cotinine	40µg/mL
Ethanol	5% v/v
E3G	620ng/mL
Glucose	20mg/mL
Gentisic acid	200µg/mL
Haemoglobin	100µg/mL
Hydrochloric acid	1.25mM
Ibuprofen	100µg/mL
Leukocytes	1x106 cells/mL
Oxytetracycline	300µg/mL
Paracetamol(Acetaminophen)	600µg/mL
P3G	40µg/mL
Phenylpropanolamine	200µg/mL
Semen	5% v/v
Sodium hydroxide	1.25mM
Tetracycline	300µg/mL
Urea	30mg/mL
Uric acid	750µg/mL
Urobilinogen	100µg/mL

{9}------------------------------------------------

{10}------------------------------------------------

Structure related compounds

The One Step Pregnancy Test devices were tested with 3 potential cross reactants. Each potential cross reactant was spiked into non-pregnant pooled urine <0.5mIU/mL and 25mIU/mL hCG urine standard at the following concentration:

Cross Reactant	Concentration
Follicle – Stimulating Hormone (FSH)	1000 mIU/mL
Luteinizing Hormone (LH)	500 mIU/mL
Thyroid – Stimulating Hormone (TSH)	1mIU/mL

Specificity of ≥99% was demonstrated when tested with potential cross reactants.

Effects of urine pH

Effect of urine pH was performed by adjusting non-pregnant pooled urine (<0.5mIU/mL) and 25mIU/mL hCG urine standard to a pH range of 4, 5, 6 (unadjusted control), 7, 8, and 9. Each urine standard was tested with 15 devices, 5 from each of 3 batches per pH condition. The results demonstrated that One Step Pregnancy Test will continue to return a correct result when tested with a urine sample in the pH range of 4 - 9.

Effect of urine specific gravity

To test the effect of specific gravity, device was challenged with negative (<0.5mIU/mL) and 25mIU/mL urine standards with the specific gravity of 1.000, 1.005, 1.016, 1.029 and 1.035. The results showed One Step Pregnancy Test will continue to return a correct result in response to changes in specific gravity within the range from 1.000 to ≤1.035.

Effect of hCG beta-core fragment (hCGβcf)

To evaluate the effect of hCGβcf, 11 conditions were tested with 5 devices from each of 3 batches, totalling 165 devices. Pooled pregnant urine collected from 6-7 weeks and 9-12 weeks pregnancy were tested with and without hCGβcf spiked up to 1μM. Pooled negative urine spiked with hCG to a concentration representative of 6-7 weeks and 9-12 weeks pregnant

{11}------------------------------------------------

urine samples were tested with and without hCGBcf spiked up to 1µM. Negative pooled urine spiked to 25mIU/mL hCG then spiked with 375pM hCGßcf (a concentration 5 times the molar concentration of intact hCG) was tested. Positive (neqative pooled urine spiked to 25mIU/mL) and nonpregnant (<0.5mIU/mL) controls were also tested.

The results show that the performance of the One Step Pregnancy Test is not affected by high concentrations of hCG ß-core fragment.

h) Assay cut-off

See Limit of Detection section.

2. Comparison Study

a. Method comparison with predicate device:
150 urine samples from pregnant women and 150 urine samples from not pregnant women were tested by trained technicians using devices across three batches of the One Step Pregnancy Test. The same samples were also tested using the predicate device QUIK-CHECK™ Home Pregnancy Test.

The One Step Pregnancy Test had 100% agreement with the QUIK-CHECK™ Home Pregnancy Test and 100% agreement with the clinical status of the volunteers' urine samples.

b. Matrix comparison:

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

3. Clinical Studies

a. Clinical Sensitivity:
Not Applicable

b. Clinical Specificity:

Not Applicable

c. Other clinical supportive data (when a. and b. are not applicable)

{12}------------------------------------------------

Detection of hCG in Early Pregnancy Clinical Samples

1197 One Step Pregnancy Test devices were tested across 3 batches with early pregnancy urine samples collected from days 0 to -9 relative to the day of the missed period.

The early pregnancy detection results are summarised in table below:

Days Relativeto MissedPeriod	Total(n)	Pregnant(n)	Pregnant(%)
-9	51	0	0.0
-8	66	0	0.0
-7	90	12	13.3
-6	132	57	43.2
-5	132	85	64.4
-4	132	121	91.7
-3	132	124	93.9
-2	132	130	98.5
-1	132	131	99.2
0	132	132	100
Not PregnantControl	66	0	0.0

Lay User Study

Pregnant and not pregnant women volunteers with diverse educational and professional backgrounds and aged over 18 years old participated in the Lay User Study. They tested their own urine sample with the One Step Pregnancy Test according to the instructions for use (IFU) provided.

The same urine sample was also tested by a technician. Volunteer results were compared to their clinical pregnancy status and to the results obtained from trained technicians.

The agreement between lay-user volunteer results and their clinical status with the One Step Pregnancy Test was 100%. There was also 100% agreement between lay-user volunteer results and technician results.

{13}------------------------------------------------

The results are summarised in tables below:

Aqreement Between Volunteer Device Results and Clinical Pregnancy Status

	Volunteer Result
		Pregnant	Not Pregnant	Total
ClinicalStatus	Pregnant	21	0	21
	Not Pregnant	0	99	99
	Total	21	99	120

Agreement Between Volunteer and Technician Results

		Volunteer Result
		Pregnant	Not Pregnant	Total
Clinical Status	Pregnant	21	0	21
	Not Pregnant	0	99	99
	Total	21	99	120

Overall, this study demonstrated that volunteers were able to use the product following the IFU to obtain a valid result.

Lay User Study on Biobank Samples

This study supports the lay user study by presenting examples of lay users reading genuine pregnant results from samples with a confirmed clinical pregnancy status.

Women volunteers aged over 18 years old participated in the Lay User Study on Biobank Samples. Volunteers tested and read the result of a single randomly selected sample (either clinically confirmed pregnant or not pregnant).

The agreement between lay-user volunteer results and the clinical status of the biobank sample with the One Step Pregnancy Test was 100%.

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

The results are summarised in table below:

Agreement Between Volunteer Device Results and Clinical Pregnancy Status

		Pregnant	Not Pregnant	Total
Clinical Status	Pregnant	70	0	70
	Not Pregnant	0	9	9
	Total	70	9	79

The overall accuracy for the One Step Pregnancy Test in the hands of volunteers was therefore 100% relative to the clinical pregnancy status of the samples tested.

Specificity study to determine false-positive result rate

A study was performed to determine the incidence of false positive results among non-pregnant women of peri-menopausal age (41-55 years) and post-menopausal age (>55 years).

150 urine samples were collected from individual women of each cohort and tested by technicians with three batches of the One Step Pregnancy Test.

The results are summarised in table below:

Cohort	Specificity(Proportion)	Specificity(%)
Peri-menopausal	150	100.0
Post-menopausal	150	100.0

The incidence of false positive results among non-pregnant women of premenopausal age were evaluated as part of the Comparison to the Predicate Study.

133 urine samples from not pregnant women aged 18-40 were tested by trained technicians usinq devices across three batches of the One Step Pregnancy Test. The results are summarised in table below:

{15}------------------------------------------------

Cohort	Specificity(Proportion)	Specificity(%)
Pre-menopausal	133	100.0

Clinical Cut-off

Not applicable.

Expected value / Reference range

Not applicable.

Conclusions

The conclusions drawn from the nonclinical tests demonstrate that the device is safe, effective and performs in accordance with its intended use. The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

Regulation Number and Section

§ 862.1155 Human chorionic gonadotropin (HCG) test system.

(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.