(398 days)
Not Found
No
The device description and performance studies indicate a standard lateral flow immunoassay with visual interpretation by the user, with no mention of AI/ML components or image processing.
No.
A therapeutic device is used for the treatment or prevention of a disease or condition. This device is an in-vitro diagnostic test used to detect pregnancy, which is a physiological state, not a disease or condition to be treated or prevented by this device.
Yes.
The device is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine as an aid in early detection of pregnancy, which is a diagnostic purpose.
No
The device description clearly states it is a lateral flow immunoassay test strip housed in a cassette, which is a physical hardware component. The user is required to visually interpret the results, indicating no software is involved in the interpretation.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of human chorionic gonadotropin (hCG) in urine." This is a test performed in vitro (outside the body) on a biological sample (urine) to provide information about a physiological state (pregnancy).
- Device Description: The description details a "lateral flow immunoassay" that detects hCG on a test strip. This is a common method used in IVD devices.
- Sample Type: The device uses urine, which is a biological specimen.
- Purpose: The purpose is to aid in the "early detection of pregnancy," which is a diagnostic purpose.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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).
Product codes
LCX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home use / Over-the-counter use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
- Analytical Performance:
- Precision/Reproducibility/Sensitivity: A pooled negative urine was spiked with hCG to provide eight urine standards with hCG concentrations of 55 years) were tested. Specificity was 100% for both cohorts.
- 133 urine samples from non-pregnant pre-menopausal women (18-40 years) were tested. Specificity was 100%.
- Precision/Reproducibility/Sensitivity: A pooled negative urine was spiked with hCG to provide eight urine standards with hCG concentrations of 55 years) were tested. Specificity was 100% for both cohorts.
Key Metrics
- Analytical Sensitivity: 25mIU/mL
- Agreement with predicate device: 100%
- Agreement with clinical status: 100% (in comparison study and lay user studies)
- Specificity (false-positive rate): 100% in peri-menopausal, post-menopausal, and pre-menopausal non-pregnant women.
Predicate Device(s)
K012215, QUIK-CHECK™ Home Pregnancy Test
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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)
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).
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 GmbH
47 Route de Saint-Georges
Petit-Lancy
CH-1213
Geneva
Switzerland
Telephone: +41 580048741 |
|---------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| B. Contact Person: | Kamila Przedmojska
Principal Regulatory Specialist
SPD Development Company Limited
Priory Business Park
Bedford
MK44 3UP
United 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: | LCX
Kit, Test, Pregnancy, hCG, over the counter
Class II
Human chorionic gonadotropin (hCG) test system
21CFR 862.1155
K210341 |
- K012215, QUIK-CHECK™ Home Pregnancy Test E. Predicate Device:
test
4
F. Indication for Use
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).
G. 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.
H. Substantial Equivalence Information
Predicate device name:
QUIK-CHECK™ Home Pregnancy Test
Predicate (k) number:
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™ Home
Pregnancy Test
(Predicate Device) |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | 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. | Intended for non-professional
/ over-the-counter use for
the qualitative identification
of hCG (human chorionic
gonadotropin) in urine to aid
in the determination of
pregnancy. |
| Target User | Over-the-counter use | Same |
| Device format | Cassette | Same |
| Analyte | hCG | Same |
| Sensitivity | 25mIU/mL | Same |
| Test Principle | Lateral flow qualitative
chromatographic immunoassay
with visual result display | Same |
| Sample
application | Sample applied as drops to
sample well via supplied
pipette | Same |
| Time to results | 3 minutes | Same |
| Result Display | Visual interpretation of
coloured lines in result window | Same |
| Differences | | |
| Traceability | WHO 4th International
Standard for hCG | WHO 3rd International
Standard for hCG |
| Early Claim | Pregnancy can be detected as
early as 4 days before the date
of the expected period (5 days
before 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 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.