Distinct® Early Detection Pregnancy Test

K193318 · ACON Laboratories, Inc. · LCX · Aug 20, 2020 · Clinical Chemistry

Device Facts

• Record ID: K193318
• Device Name: Distinct® Early Detection Pregnancy Test
• Applicant: ACON Laboratories, Inc.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Aug 20, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

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).

Device Story

The Distinct® Early Detection Pregnancy Test is a lateral flow chromatographic immunoassay for qualitative hCG detection in urine. Designed for home self-testing, the device consists of a test strip and absorbent tip housed in plastic. The user applies urine via midstream or dip method; capillary action draws the specimen across the strip. If hCG is present, it forms a sandwich complex with labeled monoclonal antibodies and pre-coated antibodies, resulting in a blue plus (+) sign in the test window. A procedural control line confirms proper wicking. Results are read visually after 3 minutes. The device aids in early pregnancy detection, allowing users to confirm pregnancy status at home without professional intervention.

Clinical Evidence

Clinical performance evaluated via user study (n=205) and early pregnancy detection study (n=65). User study demonstrated >99% accuracy compared to professional testing. Early detection study showed 100% sensitivity at the expected menstrual period (EMP) and 49.2% sensitivity 6 days before the missed period (EMP-6). Analytical testing confirmed no cross-reactivity with LH, FSH, or TSH, and no interference from common urine substances, pH (4-9), or specific gravity (1.003-1.035). No high-dose hook effect observed up to 1,000,000 mIU/mL.

Technological Characteristics

Lateral flow chromatographic immunoassay. Materials: monoclonal anti-hCG antibodies, goat anti-mouse polyclonal antibodies, plastic housing. Qualitative detection; 10 mIU/mL cutoff. Calibrated to WHO 5th International Standard for hCG. Standalone device; no software or electronics.

Indications for Use

Indicated for home use by individuals seeking early pregnancy detection via qualitative hCG urine testing. Suitable for use as early as 6 days before the missed period.

Regulatory Classification

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. 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.

Predicate Devices

• First Response Early Result Pregnancy Test (K123436)

Submission Summary (Full Text)

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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

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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 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 ([e-mail]) or phone [phone] 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

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# 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) |
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| <div style="display:flex; align-items:center;"><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |
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### 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.: [phone] Fax: [phone]

Date Prepared: August 18, 2020

#### Contact Person:

Oiyi Xie Senior Officer, Regulatory & Clinical Affairs Email: [e-mail]

#### 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.

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## 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<br>Pregnancy Test (k193318) | FIRST RESPONSE™<br>Early Result Pregnancy<br>Test (k123436) |
| Similarities | | |
| Indications for Use | The Distinct® Early Detection Pregnancy<br>Test is an aid for the early detection of<br>pregnancy intended for home use. The<br>device is a chromatographic<br>immunoassay that performs qualitative<br>detection of human chorionic<br>gonadotropin (hCG) in urine. This test<br>can help determine pregnancy as early as<br>6 days before the day of the missed<br>period (5 days before the day of the<br>expected period). | The FIRST RESPONSE ™ Early<br>Result Pregnancy Test is an over<br>the counter Chromatographic<br>immunoassay for the qualitative<br>detection of human chorionic<br>gonadotropin (hCG) in urine. The<br>device is intended for use as an aid<br>in early detection of pregnancy, in<br>some cases as early as five (5) days<br>before the expected period, i.e., as<br>early as six (6) days before the day<br>of the missed period. |
| Product Code/Regulation<br>Number | LCX/21 CFR 862.1155 | Same |
| Regulation Description | Human chorionic gonadotropin (HCG)<br>test system | Same |
| Detection Time | Early detection of pregnancy; 5 days<br>before the expected period (6 days<br>before the day of the missed period) | Same |
| Patient Use | Over the counter use/self-testing | Same |

## Comparison to the predicate device:

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| 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<br>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 | < 30°C |
| Accuracy | >99% | Same |
| Differences | | |
| Positive Result Display | A blue vertical line and a blue horizontal<br>line in the test window, a blue line in the<br>control window. | Two pink lines in the test window |
| Traceability | WHO 5th International standard for hCG | WHO 4th International standard<br>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).

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### 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.

- 2. User Performance Study

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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<br>(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<br>(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

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below:

| Time Point | Number of<br>Positive | Number of<br>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 .