(269 days)
The Distinct® Digital Pregnancy Test is an over-the-counter chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. It is intended for use as an aid for the early detection of pregnancy. This test can help determine if you are pregnant as early as 6 days before the day of the missed period (5 days before the day of your expected period).
Not Found
This letter is an FDA clearance letter and does not contain the detailed information necessary to answer all the questions about the acceptance criteria and the study proving the device meets them. The letter confirms that the Distinct® Digital Pregnancy Test has been found substantially equivalent to predicate devices and can be marketed.
However, based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The clearance letter does not provide a table of acceptance criteria or reported device performance metrics like sensitivity, specificity, accuracy, etc. These details would typically be found in the 510(k) submission summary or the device's labeling (instructions for use).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present in the FDA clearance letter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not present in the FDA clearance letter. Since this is an over-the-counter diagnostic test for hCG in urine, the "ground truth" for a pregnancy test is typically established by laboratory methods that accurately quantify hCG levels, rather than interpretation by a panel of medical experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present in the FDA clearance letter.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not present in the FDA clearance letter. This device is a "Distinct® Digital Pregnancy Test," implying it's a test that gives a digital readout (e.g., "Pregnant" or "Not Pregnant"). It's unlikely to be an AI-assisted diagnostic tool that requires human reader interpretation in the context of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not explicitly stated as an "algorithm only" study. However, as an over-the-counter digital pregnancy test, its performance is inherently standalone, meaning the user follows instructions and the device provides the result without further human interpretation beyond reading the digital display. The device itself is the "algorithm" in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for a pregnancy test like this would be established by quantitative laboratory analysis of human chorionic gonadotropin (hCG) levels in urine or blood, which is the gold standard for confirming pregnancy. The letter mentions the test is for "qualitative detection of human chorionic gonadotropin (hCG) in urine."
8. The sample size for the training set
This information is not present in the FDA clearance letter.
9. How the ground truth for the training set was established
This information is not present in the FDA clearance letter. However, similar to the test set, the ground truth for the training set (if applicable for a digital test that might use some internal calibration or digital processing) would also be established through reference methods for detecting and quantifying hCG.
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May 31, 2024
ACON Laboratories, Inc. Qiyi Xie Vice President, Regulatory/Clinical Affairs 5850 Oberlin Drive, #340 San Diego, CA 92121
Re: K232715
Trade/Device Name: Distinct® Digital Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (HCG) Test System Regulatory Class: Class II Product Code: LCX Dated: April 18, 2024 Received: April 19, 2024
Dear Qiyi Xie:
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.
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 Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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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 OS 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).
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 (OS) 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.
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-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 V. Caposino -S
Paula Caposino, Ph.D. Deputy Division 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
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Indications for Use
510(k) Number (if known) K232715
Device Name Distinct® Digital Pregnancy Test
Indications for Use (Describe)
The Distinct® Digital Pregnancy Test is an over-the-counter chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. It is intended for use as an aid for the early detection of pregnancy. This test can help determine if you are pregnant as early as 6 days before the day of the missed period (5 days before the day of your expected period).
| 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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§ 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.