(262 days)
Not Found
No
The device is a simple chromatographic immunoassay with visual interpretation of results. There is no mention of any computational analysis or algorithms, let alone AI/ML.
No
The device is a diagnostic tool for detecting pregnancy and does not provide therapy or treatment.
Yes
The device is described as an "aid for the early detection of pregnancy" and performs "qualitative detection of human chorionic gonadotropin (hCG) in urine," which directly indicates it is used to diagnose a medical condition (pregnancy).
No
The device description clearly states it is a rapid chromatographic immunoassay with a test strip and absorbent tip assembled in a plastic housing, indicating it is a physical hardware device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states it's an "aid for the early detection of pregnancy intended for home use." This indicates it's used to diagnose a condition (pregnancy) using a biological sample (urine).
- Device Description: The description details a "rapid chromatographic immunoassay for in vitro qualitative detection of human chorionic gonadotropin in urine." "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs. It's performing a test on a sample taken from the body.
- Sample Type: The test uses urine, a biological specimen.
- Analyte: It detects human chorionic gonadotropin (hCG), a specific biological marker.
- Method: It uses a "chromatographic immunoassay," a common technique for IVD tests.
All these elements align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
N/A
Intended Use / Indications for Use
The Distinct® Early Detection Pregnancy Test is an aid for the early detection of pregnancy intended for home use. The device is a chromatographic immunoassay that performs qualitative detection of human chorionic gonadotropin (hCG) in urine. This test can help determine pregnancy as early as 6 days before the day of the missed period (5 days before the day of the expected period).
Product codes (comma separated list FDA assigned to the subject device)
LCX
Device Description
The Distinct® Early Detection Pregnancy Test is a rapid chromatographic immunoassay for in vitro qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy. It is for self-testing. The test strip and absorbent tip are assembled in a plastic housing. The test strip contains monoclonal anti-hCG antibodies and goat anti-mouse polyclonal antibodies. The test result is shown in the result window and read visually after 3 minutes of urine application.
A blue sign of plus (+) at the test window indicates that hCG has been detected (pregnant). Absence of the plus (+) and only a blue line (-) in the Test Window suggests no hCG has been detected. To serve as a procedural control, a blue line will always appear in the Control Window indicating that proper volume of specimen has been added and membrane wicking has occurred.
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 / Self-testing
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
Precision/Reproducibility:
Thirty negative urine specimens were collected and spiked with WHO 5th International hCG standard to the following concentrations: 3, 5, 6, 7.5, 8, 8.5, 10, 12, 15 and 25 mIU/ml. The samples were blinded and randomized prior to being read.
User Performance Study:
A total of 205 laypersons tested their own urine with approximately half using the dip method and half using the midstream method.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
1. Analytical Performance
- Precision/Reproducibility: 300 lay users performed the test using three lots of the devices. The results demonstrated that 100% of the samples were positive at 10 mIU/mL hCG and higher using both the dip and midstream methods.
- Linearity/assay reportable range: Linearity is not applicable since this is a qualitative test.
- Traceability: The test is calibrated against the WHO 5th International Standard (IS) for Chorionic Gonadotrophin (hCG).
- Stability: The shelf life of Distinct® Early Detection Pregnancy Test was verified by accelerated, open pouch and on-going real - time stability studies which confirmed the claimed shelf life of 24 months.
- Analytical specificity (Cross Reactivity, Interference, Effects of Urine pH, Specific Gravity, High Dose Hook Effect Study, Effects of hCG B-Core Fragment): Studies showed no cross reactivity with 1000 mIU/mL FSH, 1000 µIU/mL TSH and 1000 mIU/mL LH. No interference was observed from endogenous or exogenous substances tested. No interference was observed for urine pH range 4 to 9. No influence was observed for urinary specific gravity over range 1.003 - 1.035. No hook effect was observed for hCG concentrations up to 1,000,000 mIU/mL. No hook effect was observed for hCG ß-Core Fragment concentrations up to 1,000,000 pmol/L.
2. User Performance Study
A total of 205 laypersons tested their own urine. The lay user results were compared to results from the same sample performed with the predicate device. Results showed 100% agreement between the candidate device (layperson) and predicate device (professional) for both urine stream and urine dipping methods.
3. Device performance in different age groups
A total of 300 subjects provided samples (100 for each age group: 18-40, 41-45, and 55 and older). No positive results were observed for any of the age groups among non-pregnant women.
4. Detection of hCG in Early Pregnancy Clinical Samples
Urine from 65 non-pregnant women expecting to become pregnant were collected daily starting 8 days prior to their expected period through the date of their expected menstrual period (EMP), as well as the 6th or 7th day after their EMP.
Results: - EMP +6 or 7 days: 100.0% Positive
- EMP: 100.0% Positive
- EMP-1 day: 100.0% Positive
- EMP-2 days: 100.0% Positive
- EMP-3 days: 96.9% Positive
- EMP-4 days: 93.8% Positive
- EMP-5 days: 75.4% Positive
- EMP-6 days: 49.2% Positive
- EMP-7 days: 20.3% Positive
- EMP-8 days: 10.0% Positive
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: >99% (from User Performance Study)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with an abstract design, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" on the first line, "U.S. FOOD & DRUG" on the second line, and "ADMINISTRATION" on the third line. The logo is clean and professional, reflecting the organization's role in regulating food and drugs.
August 20, 2020
Acon Laboratories Inc. Qiyi Xie Senior Officer, Clinical & Regulatory Affairs 5850 Oberlin Drive #340 San Diego, CA 92121
Re: K193318
Trade/Device Name: Distinct® Early Detection Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (HCG) Test System Regulatory Class: Class II Product Code: LCX Dated: July 22, 2020 Received: July 23, 2020
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 (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 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
1
- 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 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. Acting 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) K193318
Device Name
Distinct® Early Detection Pregnancy Test
Indications for Use (Describe)
The Distinct® Early Detection Pregnancy Test is an aid for the early detection of pregnancy intended for home use. The device is a chromatographic immunoassay that performs qualitative detection of human chorionic gonadotropin (hCG) in urine. This test can help determine pregnancy as early as 6 days before the day of the missed period (5 days before the day of the 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) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------- |
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
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The Assigned 510(k) number is K193318
Submitter's Identification:
ACON Laboratories, Inc. 5850 Oberlin Drive. # 340 San Diego, California 92121 Tel.: 858-875-8019 Fax: 858-875-8011
Date Prepared: August 18, 2020
Contact Person:
Oiyi Xie Senior Officer, Regulatory & Clinical Affairs Email: qxie@aconlabs.com
Proprietary Name of the Device:
Distinct® Early Detection Pregnancy Test
Common Name:
Over the counter Pregnancy Test
Classification Name:
21 CFR § 862.1155 Human chorionic gonadotropin (HCG) test system
Product Code:
LCX
Device Description:
The Distinct® Early Detection Pregnancy Test is a rapid chromatographic immunoassay for in vitro qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy. It is for self-testing. The test strip and absorbent tip are assembled in a plastic housing. The test strip contains monoclonal anti-hCG antibodies and goat anti-mouse polyclonal antibodies. The test result is shown in the result window and read visually after 3 minutes of urine application.
A blue sign of plus (+) at the test window indicates that hCG has been detected (pregnant). Absence of the plus (+) and only a blue line (-) in the Test Window suggests no hCG has been detected. To serve as a procedural control, a blue line will always appear in the Control Window indicating that proper volume of specimen has been added and membrane wicking has occurred.
4
Intended Use:
The Distinct® Early Detection Pregnancy Test is an aid for the early detection of pregnancy intended for home use. The device is a chromatographic immunoassay that performs qualitative detection of human chorionic gonadotropin (hCG) in urine. This test can help determine pregnancy as early as 6 days before the day of the missed period (5 days before the day of the expected period).
Test Principle:
The assay is conducted by applying urine specimen to the absorbent tip of the test. The specimen migrates via capillary action from absorbent tip to the test strip. If urine contains hCG, hCG will form a sandwich binding with particles labeled hCG monoclonal antibody and the hCG monoclonal antibody pre-coated on strip to form a blue sign of Plus (+) in Test Window. If urine does not contain hCG, absence of the plus (+) and only a blue line (-) in the test window. In Control Window, particles labeled with mouse IgG will bind pre-coated goat anti-mouse IgG to form a blue Control Line.
| Candidate Device | Predicate Device | |
|---|---|---|
| Area of Comparison | Distinct® Early Detection | |
| Pregnancy Test (K193318) | FIRST RESPONSE™ | |
| Early Result Pregnancy | ||
| Test (K123436) | ||
| Similarities | ||
| Indications for Use | The Distinct® Early Detection Pregnancy | |
| Test is an aid for the early detection of | ||
| pregnancy intended for home use. The | ||
| device is a chromatographic | ||
| immunoassay that performs qualitative | ||
| detection of human chorionic | ||
| gonadotropin (hCG) in urine. This test | ||
| can help determine pregnancy as early as | ||
| 6 days before the day of the missed | ||
| period (5 days before the day of the | ||
| expected period). | The FIRST RESPONSE ™ Early | |
| Result Pregnancy Test is an over | ||
| the counter Chromatographic | ||
| immunoassay for the qualitative | ||
| detection of human chorionic | ||
| gonadotropin (hCG) in urine. The | ||
| device is intended for use as an aid | ||
| in early detection of pregnancy, in | ||
| some cases as early as five (5) days | ||
| before the expected period, i.e., as | ||
| early as six (6) days before the day | ||
| of the missed period. | ||
| Product Code/Regulation | ||
| Number | LCX/21 CFR 862.1155 | Same |
| Regulation Description | Human chorionic gonadotropin (HCG) | |
| test system | Same | |
| Detection Time | Early detection of pregnancy; 5 days | |
| before the expected period (6 days | ||
| before the day of the missed period) | Same | |
| Patient Use | Over the counter use/self-testing | Same |
Comparison to the predicate device:
5
| Intended Specimen | Urine | Same |
|---|---|---|
| Usage Type | Single -use | Same |
| Assay Technique | Immunochromatographic Assay | Same |
| Test Result | Qualitative | Same |
| Antigen Specificity | hCG β-core fragment | Same |
| Dose Hook Effect | No Dose-Hook effect was observed at | |
| 1000,000 mIU/ml | Same | |
| Sample Collection Method | Midstream method, dip method | Same |
| Sample Application Time | 5-10 seconds | 5 seconds |
| Reading Time | 3 - 10 minutes | 3 minutes |
| Storage Temperature | 2- 30°C | 99% |
| Differences | ||
| Positive Result Display | A blue vertical line and a blue horizontal | |
| line in the test window, a blue line in the | ||
| control window. | Two pink lines in the test window | |
| Traceability | WHO 5th International standard for hCG | WHO 4th International standard |
| for hCG |
Discussion of Performance Tests Performed:
1.Analytical Performance
-
a. Precision/Reproducibility:
The purpose of this study is to determine the reproducibility of Distinct® Early Detection Pregnancy Test when performed by lay users. Thirty negative urine specimens were collected and spiked with WHO 5th International hCG standard to the following concentrations: 3, 5, 6, 7.5, 8, 8.5, 10, 12, 15 and 25 mIU/ml. The samples were blinded and randomized prior to being read. A total of 300 lay users performed the test using three lots of the devices. The results demonstrated that 100% of the samples were positive at 10 mIU/mL hCG and higher using both the dip and midstream methods. -
b. Linearity/assay reportable range:
Linearity is not applicable since this is a qualitative test. -
Traceability and Stability: C.
Traceability:
The test is calibrated against the WHO 5th International Standard (IS) for Chorionic Gonadotrophin (hCG).
6
Stability
The shelf life of Distinct® Early Detection Pregnancy Test was verified by accelerated, open pouch and on-going real - time stability studies which confirmed the claimed shelf life of 24 months.
d. Analytical specificity:
Cross Reactivity
The purpose of this study is to determine if Distinct® Early Detection Pregnancy Test has cross reaction with relative substances, such as LH, FSH and TSH. Results of the study showed no cross reactivity with 1000 mIU/mL FSH, 1000 µIU/mL TSH and 1000 mIU/mL LH.
Interference
The purpose of this study is to evaluate the effect of potentially interfering substances commonly found in human urine on Distinct® Early Detection Pregnancy Test. Results of the study demonstrated that none of the endogenous or exogenous substances tested interfered with the expected results.
Effects of Urine pH
The purpose of this study is to determine the effect of urine pH on Distinct® Early Detection Pregnancy Test. From the results of the study, it was concluded that the pH of the samples, when tested from a range pH 4 to pH 9 did not interfere with the performance of Distinct® Early Detection Pregnancy Test.
Specific Gravity
The purpose of this study is to determine the effect of urine specific gravity on Distinct® Early Detection Pregnancy Test. From the results of the study, it was concluded that the different urinary specific gravity over the range of 1.003 - 1.035 does not influence the results of Distinct® Early Detection Pregnancy Test.
High Dose Hook Effect Study
The purpose of this study is to evaluate if there is a hook effect causing false negative results at high hCG concentrations. hCG concentrations of 500, 1000, 10,000, 100,000, 500,000, and 1,000,000 mIU/mL were tested and no hook effect was observed.
Effects of hCG B-Core Fragment
The purpose of this study is to evaluate if there is a hook effect causing false negative results due to high concentrations of hCG ß-Core Fragment. Concentrations of B-Core Fragment up to 1,000.000 pmol/L were tested and no hook effect was observed.
-
- User Performance Study
7
The purpose of the user comparison study was to determine if the Distinct® Early Detection Pregnancy Test can be performed correctly by laypersons. A total of 205 laypersons tested their own urine with approximately half using the dip method and half using the midstream method. The lay user results were compared to results from the same sample performed with the predicate device. Results are summarized below:
| Predicate (Professional) | ||||
|---|---|---|---|---|
| Urine stream Method | Pos | Neg | Total | |
| Candidate | ||||
| (Layperson) | Pos | 51 | 0 | 51 |
| Neg | 0 | 51 | 51 | |
| Total | 51 | 51 | 102 |
Candidate device (layperson) vs. predicate device (professional)
| Urine Dipping Method | Predicate (Professional) | |||
|---|---|---|---|---|
| Pos | Neg | Total | ||
| Candidate | ||||
| (Layperson) | Pos | 52 | 0 | 52 |
| Neg | 0 | 51 | 51 | |
| Total | 52 | 51 | 103 |
The study results indicate that the Distinct® Early Detection Pregnancy Test can be performed by laypersons correctly and it is easy to use. The accuracy is over 99%.
3. Device performance in different age groups
The purpose of the study is to determine the incidence of positive test results using the candidate device among non-pregnant women in three age groups: 18-40, 41-45, and 55 and older. A total of 300 subjects provided samples with 100 for each age group. Three lots of the candidate device were used for this study. No positive results were observed for any of the age groups ..
4. Detection of hCG in Early Pregnancy Clinical Samples
The purpose of the study is to determine how soon before the expected menstrual period (EMP) the candidate device can detect pregnancy. Urine from 65 nonpregnant women expecting to become pregnant were collected daily starting 8 days prior to their expected period through the date of their expected menstrual period (EMP), as well as the 6th or 7th day after their EMP. Results are summarized
8
below:
| Time Point | Number of
Positive | Number of
Negative | % Positive |
|------------------|-----------------------|-----------------------|------------|
| EMP +6 or 7 days | 65 | 0 | 100.0% |
| EMP | 65 | 0 | 100.0% |
| EMP-1 day | 65 | 0 | 100.0% |
| EMP-2 days | 65 | 0 | 100.0% |
| EMP-3 days | 63 | 2 | 96.9% |
| EMP-4 days | 61 | 4 | 93.8% |
| EMP-5 days | 49 | 16 | 75.4% |
| EMP-6 days | 32 | 33 | 49.2% |
| EMP-7 days | 13 | 51 | 20.3% |
| EMP-8 days | 6 | 54 | 10.0% |
Conclusion:
The laboratory testing results, and clinical studies demonstrate that the Distinct® Early Detection Pregnancy Test is substantially equivalent to the FIRST RESPONSE™ Early Result Pregnancy Test cleared under K123436 .