Regulatory Landscape - Overview

Pregnancy Test Kits Regulatory Landscape: Product Overview

Pregnancy test kits are diagnostic tools used to detect presence of human chorionic gonadotrophin (hCG), a hormone released during pregnancy in urine or blood of the pregnant women. These kits provide women’s quick and non-invasive, easy to use technique to confirm pregnancy at home.

Pregnancy Test Kits Types

Pregnancy tests are segmented into two types including, Urine and Blood tests.

Urine Tests: These are the most frequently used type of test for pregnancy, which can be used at home by the own self without the need of going to hospital or taking healthcare providers help, these are further segmented into 2 types, and they are as follows:

• Strip or Dipstick Tests: This test requires dipping the test strip or dipstick in urine and incubating for few minutes and then observing for appearance of a coloured line or symbol.
• Midstream Tests: This test needs to either hold stick having absorbent tip in urine stream for few seconds or collecting urine in cup and then dipping the stick in urine collected in cup, then observing the results on the surface of the dipped stick.

Blood Tests: This type of test is less commonly used and requires to be performed at healthcare settings, they are of two types;

• Qualitative hCG Blood Test: This test indicates if hCG is present in the blood or not, indicating a possible pregnancy.
• Quantitative hCG Blood Test: This test can indicate the precise and accurate amount of hCG in the bloodstream, which can help to find stage of pregnancy.

Mechanism of action of Pregnancy Test Kits

Pregnancy test kit indicates presence or absence of hormone human chorionic gonadotropin (hCG) hormone released by placenta into the urine and bloodstream during pregnancy, indicating the presence or absence of pregnancy.

Mechanism of action include use of monoclonal antibodies corresponding to hCG hormone in urine and blood sample for detection, these antibodies are designed in such a way that when they bind with the hCG hormone they form visible band or signal indicating the presence of hormone.

Kit contains a test strip with the absorbent end, if the sample contain the hCG, then, monoclonal antibodies on test strip when dipped in urine sample will bind to the hCG, will show visible signal like coloured line indicating positive pregnancy test result. If a pregnancy test result is negative, means there was no presence of hCG in the urine sample of women, therefore it did not detect the hormone Human chorionic gonadotropin (hCG), and as a result there were no visible signals indicating absence of pregnancy.

Pregnancy Test Kits Applications

Early Detection of Pregnancy: They allowing individuals with early detection of pregnancy, mostly before a missed period, by measuring levels of hormone hCG (human chorionic gonadotropin) in urine.

Convenience and Privacy: These kits provide a private and convenient way to confirm pregnancy without the need for a doctor's visit initially.

Family Planning: They help individuals and couples make timely decisions regarding family planning, whether they are trying to conceive or avoid pregnancy.

Medical Guidance: Early detection can prompt timely medical advice and care, which is crucial for the health of both the mother and the developing fetus.

Reassurance: For those undergoing fertility treatments or experiencing irregular menstrual cycles, pregnancy kits can offer reassurance and reduce anxiety by providing quick results.

Cost-Effective: Home pregnancy tests are generally more affordable compared to laboratory tests, making them accessible to a wider population.

Pregnancy Test Kits Product Development Steps:

Food and drug administration has centre for device and radiological health (CDRH) which s mainly responsible for evaluation of all medical devices including invitro devices like pregnancy test kits to ensure the safety, efficacy and quality of the product.

                                   Figure- FDA product Development and Approval Process.

Pregnancy Test Kits Market Size Overview:

As per MRFR analysis, the Pregnancy Test Kits Market Size was estimated at 1.63 (USD Billion) in 2024. The Pregnancy Test Kits Market Industry is expected to grow from 1.72 (USD Billion) in 2025 to 2.71 (USD Billion) till 2034, at a CAGR (growth rate) is expected to be around 5.22% during the forecast period (2025 - 2034). The market drivers for pregnancy test kits is likely to expand over the forecast period as a result of rising rates of adolescent pregnancies, rising demand for self-detective pregnancy tests, and shifting social attitudes toward planned pregnancies worldwide

                                                   Pregnancy Test Kits Regulatory Landscape:

There are several key regulatory agencies who oversee the approval and monitoring of Pregnancy Test Kits to ensure their safety, efficacy, and quality.

Pregnancy Test Kits Guidelines:

Test are designed for those Women who doubt if they are pregnant, including those who missed their periods or experienced early pregnancy symptoms. It is even used by the women trying to conceive, to confirm pregnancy in early stage, or it is also used by women facing irregular periods cycle, to check if the missed period is due to pregnancy or not.

Best time to undertake the test is using early morning first urine of the day, as it is more concentrated and has high levels of hCG, testing later in day after drinking lots of fluid will dilute the urine and can show false positive results, also testing should be done by following proper steps mentioned on the kit labels, mis-steps like less incubation time with urine than mentioned can affect the accuracy of the results.

Women who test too soon after conception may not have detectable levels of hCG, leading to false negatives Women with specific medical conditions or those taking certain medications may receive false positives or negatives, for instance, Conditions like ovarian cysts or recent miscarriage/abortion can cause false positives due to lingering hCG levels and Certain medications, especially those containing hCG (used in fertility treatments), can interfere with test results.

Pregnancy Test Kits Classification of the Product:

Pregnancy Test Kits Regulatory Process Overview, By Country:

To launch over the counter (OTC) pregnancy test kit to market in US, manufacturers must adhere to the regulatory framework issued by the FDA who is responsible for maintaining the product safety, quality and efficacy. Medical devices are regulated by the centre for drug and radiological health (CDRH) under FDA.

Medical devices are classified as class I, II, III by the food and drug administration (FDA), class I devices pose low risk to the individual using it and need submission of only general controls, class II devices are considered to pose moderate risk to the individual and need general plus special controls submission including premarket notification 510 (k) and the class III devices are of high risk, has strict regulatory framework and need premarket approval (PMA) submission during the product approval process.

Pregnancy test kits are the medical devices falling in the category of class II, under 21 CFR 862.1155 under medical devices segmentation given by the FDA. These devices need premarket notification 510(k) submission, for involving submission of evidence that the product is substantially equivalent to one of the legally market devices.

Key regulatory steps for OTC pregnancy test kits

Device classification and regulatory pathway

OTC pregnancy test kit fall under in vitro diagnostic test kit with product code LCX and is regulated as class II devices. They need premarket notification 510(k) to prove substantial equivalence to legally market devices.

Performance Evaluation

• Assay Cutoff: Determine the cutoff concentration that yields a positive result 50% of the time and a negative result 50% of the time.
• Precision: Evaluate precision by testing samples with hCG concentrations that span the assay range. This includes multiple lots, operators, sites, days, and instruments.
• Stability: Conduct stability studies to ensure the test's reliability over time.
• Sensitivity: Sensitivity is the analyte concentration at which 95% of test results are positive.

Evaluate sensitivity by spiking clinical samples with various hCG concentrations, Provide concentrations tested in the 510(k) submission.

• Interference and Specificity: Test for potential interference from substances like LH, FSH, TSH, prescription/OTC drugs, and other chemical and biological analytes.

 Accuracy

• Method Comparison and User-Accuracy: Compare the new device's results with the substantially equivalent device and evaluate user accuracy.

Labeling

• Clear and Accurate Labeling: Ensure that the Labeling is clear, accurate, and free from misleading statements. Express data in terms of percent accuracy, not exceeding 99%, and avoid misleading statements like "virtually 100% accurate” or nearly 100% accurate.

Post-Market Evaluation

• Ongoing Monitoring: Conduct post-market evaluations to monitor the device's performance and address any issues that arise, FDA inspects the product after its market entry through FDA MedWatch Program, MedSun Program, Medical Device Reports.

Comparison Study/OTC Study -Study Design:

• Use at least 100 fresh, human urine specimens.
• Split specimens between subject and professional for testing on both the predicate and new device, Subjects should mimic actual use without assistance.
• Use freshly voided first-morning urine specimens or samples collected any time of day if claims are made for such use. Provide coded positive and negative specimens for home users.
• Validate equivalency for devices with multiple testing procedures, Select OTC users randomly, ensuring diversity.
• Include a summary of the OTC study protocol in the 510(k) submission.

Antibody Information

510 (k) submission should Include information on monoclonal antibody characterization and purification. Provide a Certificate of Analysis if performed by another manufacturer.

Labelling and Limitations

Labels of the product should include the intended use, expiry date of the product, explanation of test, expected values etc.

Labelling should also Include necessary limitations , like test can’t be reused, don’t use after expiry date, certain health conditions can show false or irregular results like ovarian cyst and ectopic pregnancy, for accurate results precise protocol for use of the kit should be followed, or if urine is too much diluted false negative results can be shown, and mention of – for invitro diagnostic use only ( not for internal use).

These steps ensure compliance with FDA guidelines for the evaluation and submission of in vitro diagnostic devices

Pregnancy Test Kits Industry Developments

June 2022: PregaScreen, an at-home pregnancy test kit that enables women to determine their own pregnancy status, was introduced by Mylab Discovery Solutions.

April 2022: Prega News Advanced, a brand-new and sophisticated pregnancy test kit from Mankind Pharma, was introduced for the Indian market. It is the simplest and most practical way to test for pregnancy at home because the product contains a single-step pregnancy test equipment that does not involve collecting pee in a dropper or a container.

Pregnancy Test Kits Regulatory Challenges and possible risk in the development of the product:

FDA Clearance: Pregnancy test kits are regulated as class II medical devices which needs premarket notification 510(k), requiring evidence of substantially equivalent legally marketed predicate device to the new developed product, FDA will hold the clearance if the product is not complying with this guidelines.

Performance Standards: Manufacturing companies should meet the performance standards like accuracy, precision, specificity for their products, if this parameters are not fulfilled by the product under the approval process, FDA will not give the approval to launch and market this product.

International Regulations: Different countries have varying regulatory requirements, which can complicate the process for manufacturers looking to market their products globally. Compliance with each country's specific regulations is essential.

Technological Advancements: evolving technology brings new types of pregnancy tests (e.g., digital tests), which can face additional regulatory issues to ensure that they meet the same standards as traditional tests.

Post-Market Surveillance: Continuous monitoring of the product's performance after it has been marketed is necessary to identify any issues that may arise and to ensure ongoing compliance with regulatory standards. If any product fails in this or any issue related to product is found, then it can lead to product recall.

Cost Management: Balancing the costs of development, production, and marketing while maintaining a competitive price point can be difficult. High costs can impact profitability.

Pregnancy Test Kits Competitive Landscape Dashboard:

Companies With Marketed Pregnancy Test Kits Products

• Alere Inc. (US)
• Prestige Brands Holdings Inc (US)
• Quidel Corporation (US)
• Procter & Gamble Co. (Germany)
• Piramal Enterprises (India)
• Cardinal Health (US)
• Confirm Biosciences (US)