(343 days)
Not Found
No
The device description and performance studies focus on a traditional immunochromatographic assay with a visual readout. There is no mention of AI, ML, image processing, or data-driven algorithms for result interpretation.
No.
The device is a diagnostic tool used to detect pregnancy, not to treat or cure a medical condition.
Yes
The device qualitatively detects human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy, which is a physiological condition. Detecting pregnancy helps in the diagnosis of a specific physiological state.
No
The device description clearly indicates it is a physical, over-the-counter chromatographic immunoassay (lateral flow test strip) that detects hCG in urine. It is a hardware device.
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." Detecting substances in bodily fluids to aid in diagnosis (in this case, pregnancy) is a core function of IVDs.
- Device Description: The description details an "immunochromatographic sandwich assay to detect hCG on a lateral flow test strip." This describes the mechanism of an in vitro test.
- Performance Studies: The document includes detailed performance studies like "Precision/Reproducibility," "Analytical Specificity," and "Detection of hCG in Early Pregnancy Clinical Samples." These are standard types of studies conducted to validate the performance of IVD devices.
- Key Metrics: The document provides key metrics like Sensitivity, Specificity, PPV, and NPV, which are crucial performance indicators for IVD tests.
- Predicate Device: The mention of a "Predicate Device" (K123436; FIRST RESPONSE™ Early Result Pregnancy Test) is a strong indicator that this device is being submitted for regulatory review as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.
In summary, the Clearblue® Early Pregnancy Test meets the definition of an In Vitro Diagnostic device because it is intended to be used outside the body to examine specimens (urine) from the human body to provide information for the diagnosis of a condition (pregnancy).
N/A
Intended Use / Indications for Use
The Clearblue® Early Pregnancy Test is an over-the-counter chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, i.e. as early as five (5) days before the day of the expected period.
The test is intended for home use.
Product codes (comma separated list FDA assigned to the subject device)
LCX
Device Description
The Clearblue® Early Pregnancy Test is an over-the-counter (OTC), visual pregnancy test and is indicated for use up to 6 days before the missed period (5 days before expected period). The device employs an immunochromatographic sandwich assay to detect hCG on a lateral flow test strip.
The test incorporates a proprietary, FSH modulated, hCG scavenger system positioned upstream of the hCG test line to maintain high specificity to pregnancy. The scavenger system captures hCG when there are high levels of FSH in the sample. This ensures that hCG is removed from samples with elevated levels of FSH, reducing the chance of false positive results which while rare, may occur in some women.
The result is displayed to the user in the test window as two lines for a 'Pregnant' result and one line for a `Not Pregnant' result.
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.
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
Detection of hCG in Early Pregnancy Clinical Samples
Early pregnancy urine samples from days -10 to 0 relative to the day of the missed period were collected. Each sample was tested using both methods of sampling across three batches of devices.
Lay User Study
Pregnant and not pregnant women volunteers with diverse educational and professional backgrounds and ages between 18 and 55 years old participated in the Lay User Usage Study. Their results were compared to their clinical pregnancy status and to the results obtained from trained technicians testing the same urine samples in the same sampling method (either simulated in-stream or dipping).
Lay User Spiked Standard Study
A study was performed to analyse the performance of the Clearblue® Early Pregnancy Test when read by lay user according to the Instructions for Use. A range of the hCG urine standards at 0, 2, 3, 5, 10 and 15mIU/ml were sampled by dip method of sampling and read by lay users.
Specificity study to determine false-positive result rate
A study was performed to determine the incidence of false positive results among not-pregnant women of pre-menopausal age (18-40 years), perimenopausal age (41-55 years) and post-menopausal age (>55 years). Urine samples were collected from individual women of each cohort and were tested by technicians with three batches of the Clearblue® Early Pregnancy Test devices by both dip and simulated in-stream method of sampling.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical Performance - Precision/Reproducibility
A not-pregnant pooled urine was spiked with hCG traceable to the 4th WHO international standard with hCG concentrations of
§ 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.
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September 21, 2022
SPD Swiss Precision Diagnostics GmbH % Kamila Przedmojska Principal Regulatory Affairs Specialist SPD Development Company Limited Priory Business Park, Stannard Way Bedford, Bedfordshire MK44 3UP United Kingdom
Re: K213379
Trade/Device Name: Clearblue® Early Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (hCG) Test System Regulatory Class: Class II Product Code: LCX Dated: June 24, 2022 Received: July 5, 2022
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.
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
1
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 (OS) 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Paula Caposino, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213379
Device Name Clearblue® Early Pregnancy Test
The Clearblue® Early Pregnancy Test is an over-the-counter chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, i.e. as early as five (5) days before the day of the expected period.
The test is intended for home use.
| Type of Use ( Select one or both, as applicable ) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |||
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/2 description: The image shows 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 is colored with a gradient that 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 Affairs Specialist
SPD Development Company Limited
Priory Business Park
Bedford
MK44 3UP
United Kingdom
Telephone: +44 1234835504 |
| C. Date Prepared: | 24 June, 2022 |
| D. Device Name: | Clearblue® Early Pregnancy Test |
| Product Code: | LCX |
| Common name: | Kit, Test, Pregnancy, hCG, over the counter |
| Classification: | Class II |
| Product code: | LCX |
| Regulation Description: | Human chorionic gonadotropin (hCG) test system |
| Regulation number: | 21CFR 862.1155 |
| E. Predicate Device: | FIRST RESPONSE™ Early Result Pregnancy Test
(K123436) |
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F. Indication for Use
Clearblue® Early Pregnancy Test is an over-the-counter The chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, i.e. as early as five (5) days before the day of the expected period.
The test is intended for home use.
G. Device Description
The Clearblue® Early Pregnancy Test is an over-the-counter (OTC), visual pregnancy test and is indicated for use up to 6 days before the missed period (5 days before expected period). The device employs an immunochromatographic sandwich assay to detect hCG on a lateral flow test strip.
The test incorporates a proprietary, FSH modulated, hCG scavenger system positioned upstream of the hCG test line to maintain high specificity to pregnancy. The scavenger system captures hCG when there are high levels of FSH in the sample. This ensures that hCG is removed from samples with elevated levels of FSH, reducing the chance of false positive results which while rare, may occur in some women.
The result is displayed to the user in the test window as two lines for a 'Pregnant' result and one line for a `Not Pregnant' result.
H. Substantial Equivalence Information
Predicate device name: FIRST RESPONSE™ Early Result Pregnancy Test
Predicate (k) number: K123436
Comparison with predicate:
Table 1 Similarities and differences between Clearblue® Early Pregnancy Test and the predicate FIRST RESPONSE™ Early Results Pregnancy Test
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| Component | Clearblue® Early Pregnancy
Test (Proposed Device) | FIRST RESPONSE™ Early
Result Pregnancy Test
(Predicate Device) |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| | | Similarities |
| Intended Use | Qualitative detection of human
hCG for an aid in early detection
of pregnancy | Same |
| 'Early Test'
Claim | in some cases as early as six (6)
days before the day of the missed
period, i.e. as early as five (5)
days before the day of the
expected period. | Same |
| Target User | Over-The-Counter use | Same |
| Device format | Single Use | Same |
| Sample Matrix | Urine | Same |
| Analyte | hCG | Same |
| Sample
application | In-stream and dip | Same |
| hCG
Sensitivity | 10mIU/ml | Same |
| Traceability | WHO 4th International Standard
for hCG | Same |
| Test Principle | Lateral flow sandwich immuno-
chromatographic assay | Same |
| Assay Mobile
Phase | Gold conjugate | Same |
| Test Type | Qualitative | Same |
| Control
Mechanism | Visual | Same |
| Results
Display | Visual Parallel Line
2 Lines = Pregnant
1 Line = Not Pregnant | Same |
| | | Differences |
| Analyte
Detection | Detects intact hCG.
Scavenger system to remove
intact hCG in the presence of
FSH. | Recognises: intact hCG
hyperglycosylated hCG
hCG ẞ-subunit
hCG ẞ-core fragment |
| Time to
results | 5 minutes | 3 minutes |
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I. Test Principle
The Clearblue® Early Pregnancy test is a lateral flow sandwich immunoassay employing monoclonal antibodies that are specifically directed against the alpha and beta sub-units of hCG.
To use the Clearblue® Early Pregnancy test, the user either urinates directly onto the absorbent wick or collects a sample in a container and dips the absorbent wick into the collected sample.
Buffer salts in the wick are dissolved by the sample, normalising the pH and ionic strength to provide suitable conditions for the down-stream immunoassay. Upon wetting of the wick, urine is drawn by capillary action into the conjugate pad. As the sample moves from the wick through the conjugate release pad, the antibody coated gold-sol particles are mobilized and transported along the test strip. Any hCG and/or FSH in the sample will bind to the test gold-sol label via their common alpha sub-unit.
On reaching the nitrocellulose membrane, the sample is drawn across the plotted line of immobilised anti-beta FSH antibody in the scavenger zone which is not visible to the user as it is located within the plastic case moulding. The sample then progresses across the monoclonal anti-beta hCG antibody test line and polyclonal anti-rabbit antibody control line and on to the distal end of the test strip into the sink pad.
J. Performance characteristics
1. Analytical Performance
a) Precision/Reproducibility
- A not-pregnant pooled urine was spiked with hCG traceable to the 4th WHO international standard with hCG concentrations of 55 years). Urine samples were collected from individual women of each cohort and were tested by technicians with three batches of the Clearblue® Early Pregnancy Test devices by both dip and simulated in-stream method of sampling.
The results (combined method of sampling) are summarised in table below:
| Cohort | Not Pregnant
(n) | Samples
(n) | Specificity
(%) |
|------------------|---------------------|----------------|--------------------|
| Pre-menopausal | 300 | 300 | 100 |
| Peri-menopausal | 299 | 299 | 100 |
| Post-menopausal | 300 | 300 | 100 |
| All Not Pregnant | 899 | 899 | 100 |
Clinical Cut-off
Not applicable.
Expected value
Not applicable.
K. Conclusion
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.