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 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.

AI/ML Overview

The provided information describes the validation study for the "Distinct® Early Detection Pregnancy Test." Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a separate section with specific thresholds. However, based on the studies performed, the implied performance criteria for this qualitative immunoassay are high agreement with a predicate device and high sensitivity (low detection limit for hCG).

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Analytical Sensitivity (Detection Limit)	Detect 10 mIU/mL hCG with 100% positivity	100% of samples were positive at 10 mIU/mL hCG and higher.
Accuracy (Lay User vs. Professional)	>99% agreement with predicate device (professional use)	Urine Stream Method: 100% agreement (51 Pos, 51 Neg by both, 0 disagreement).
		Urine Dipping Method: 100% agreement (52 Pos, 51 Neg by both, 0 disagreement). Overall accuracy >99%.
Cross-Reactivity	No cross-reactivity with FSH, TSH, LH up to 1000 mIU/mL/µIU/mL	No cross-reactivity observed with 1000 mIU/mL FSH, 1000 µIU/mL TSH, and 1000 mIU/mL LH.
Interference	No interference from common endogenous/exogenous substances	None of the tested endogenous or exogenous substances interfered with expected results.
pH Effects	No interference from urine pH 4-9	Urine pH range of 4 to 9 did not interfere with performance.
Specific Gravity Effects	No interference from urine specific gravity 1.003-1.035	Urinary specific gravity over the range of 1.003 - 1.035 did not influence results.
High Dose Hook Effect	No false negatives at high hCG concentrations up to 1,000,000 mIU/mL	No hook effect observed at hCG concentrations up to 1,000,000 mIU/mL.
hCG ß-Core Fragment Effects	No false negatives due to high ß-Core Fragment concentrations	No hook effect observed at ß-Core Fragment concentrations up to 1,000,000 pmol/L.
Early Pregnancy Detection	Detect pregnancy at various days before expected period (comparable to predicate)	EMP: 100% positive; EMP-1 day: 100% positive; EMP-2 days: 100% 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.
Negative Predictive Value (Non-Pregnant Women)	No false positives in non-pregnant women across age groups	No positive results observed for any of the 300 non-pregnant subjects across three age groups.
Ease of Use (Laypersons)	Can be performed correctly and is easy to use by laypersons	Study results indicate it can be performed correctly by laypersons and is easy to use.

2. Sample Size Used for the Test Set and the Data Provenance:

Precision/Reproducibility Study:
- Sample Size: 30 negative urine specimens spiked with hCG at various concentrations (3, 5, 6, 7.5, 8, 8.5, 10, 12, 15, and 25 mIU/mL).
- Data Provenance: Not explicitly stated, but implies laboratory-prepared samples. Retrospective (spiked samples).
User Performance Study:
- Sample Size: 205 laypersons.
- Data Provenance: Not explicitly stated, but implies U.S. or similar country where FDA approval is sought. Prospective (lay users testing their own urine).
Device Performance in Different Age Groups:
- Sample Size: 300 subjects (100 for each age group: 18-40, 41-45, and 55+).
- Data Provenance: Not explicitly stated. Prospective (subjects providing samples).
Detection of hCG in Early Pregnancy Clinical Samples:
- Sample Size: 65 non-pregnant women expecting to become pregnant.
- Data Provenance: Not explicitly stated. Prospective (daily urine collection from women).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

Precision/Reproducibility Study: The ground truth (hCG concentration) was established by spiking negative urine specimens with known concentrations of WHO 5th International hCG standard. No human experts were explicitly mentioned for interpreting the spiked samples' "true" status, as it's a controlled analytical test.
User Performance Study: The ground truth for comparative results was established by professional testing with the predicate device using the same samples tested by laypersons. The qualifications of these professionals are not specified beyond "professional" use.
Device Performance in Different Age Groups: The ground truth for "non-pregnant" status was assumed based on the study design for non-pregnant women. No experts were mentioned for establishing ground truth; it was based on the absence of hCG.
Detection of hCG in Early Pregnancy Clinical Samples: The ground truth of pregnancy status was inferred from positive hCG results over time relative to the expected menstrual period. It's not explicitly stated that an "expert" individually established the ground truth for each sample. The study assesses the device's ability to detect hCG in early pregnancy, with the "truth" being the presence or absence of a detectable hCG level over time.

4. Adjudication Method for the Test Set:

The document does not describe a formal adjudication method (e.g., 2+1, 3+1 consensus) for establishing ground truth from multiple human readers for any of the studies.
In the User Performance Study, the comparison was between the layperson's interpretation of the candidate device and a professional's interpretation of the predicate device (or presumably, professional interpretation of the candidate device in parallel, though the wording specifies "compared to results from the same sample performed with the predicate device"). This implies a direct comparison rather than an adjudication process involving multiple readers for consensus.

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:

No, an MRMC comparative effectiveness study involving AI assistance for human readers was not done. This device is a rapid chromatographic immunoassay (a traditional dipstick-style pregnancy test) and does not involve AI or digital image analysis by human readers. The "reader" is directly the lay user who visually interprets the test line.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

No, a standalone algorithm performance study was not done. The device is a visual qualitative test designed for direct human interpretation. There is no algorithm involved in interpreting the results.

7. The Type of Ground Truth Used:

Analytical Performance Studies (Precision, Cross-Reactivity, Interference, Hook Effect, etc.): The ground truth was primarily based on known concentrations of spiked hCG and other substances (e.g., WHO 5th International Standard for hCG, known concentrations of interfering substances).
User Performance Study: The ground truth for comparison was established by professional use of a predicate device on the same samples.
Device Performance in Different Age Groups: Ground truth was based on the confirmed non-pregnant status of the subjects.
Detection of hCG in Early Pregnancy Clinical Samples: Ground truth for pregnancy detection over time was based on the presence/absence of hCG in urine samples collected prospectively from women trying to conceive, with "positive" samples validated by the test itself and monitored over time relative to the expected period.

8. The Sample Size for the Training Set:

This device is a traditional immunoassay, not an AI/ML device. Therefore, the concept of a "training set" for an algorithm is not applicable. The device itself (the physical test strip) is manufactured based on established principles of immunoassay development.

9. How the Ground Truth for the Training Set Was Established:

As stated above, there is no training set as this is not an AI/ML device. The "ground truth" in the development of such assays typically comes from established scientific principles, calibrated reference materials (like WHO standards), and extensive R&D to ensure the antibodies and reagents perform as expected for hCG detection.

Summary

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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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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

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Indications for Use

510(k) Number (if known) K193318

Device Name

Distinct® Early Detection Pregnancy Test

Indications for Use (Describe)

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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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:

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Intended Use:

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 DetectionPregnancy Test (K193318)	FIRST RESPONSE™Early Result PregnancyTest (K123436)
Similarities
Indications for Use	The Distinct® Early Detection PregnancyTest is an aid for the early detection ofpregnancy intended for home use. Thedevice is a chromatographicimmunoassay that performs qualitativedetection of human chorionicgonadotropin (hCG) in urine. This testcan help determine pregnancy as early as6 days before the day of the missedperiod (5 days before the day of theexpected period).	The FIRST RESPONSE ™ EarlyResult Pregnancy Test is an overthe counter Chromatographicimmunoassay for the qualitativedetection of human chorionicgonadotropin (hCG) in urine. Thedevice is intended for use as an aidin early detection of pregnancy, insome cases as early as five (5) daysbefore the expected period, i.e., asearly as six (6) days before the dayof the missed period.
Product Code/RegulationNumber	LCX/21 CFR 862.1155	Same
Regulation Description	Human chorionic gonadotropin (HCG)test system	Same
Detection Time	Early detection of pregnancy; 5 daysbefore the expected period (6 daysbefore 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 at1000,000 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 horizontalline in the test window, a blue line in thecontrol window.	Two pink lines in the test window
Traceability	WHO 5th International standard for hCG	WHO 4th International standardfor 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.

1. 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(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

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below:

Time Point	Number ofPositive	Number ofNegative	% 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 .

Regulation Number and Section

§ 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.