The ACRO hCG Pregnancy Rapid Test is used by the consumer for the visual qualitative detection of Human Chorionic Gonadotropin (hCG) in urine. It is used to detect the pregnancy of HCG in urine as an indication of pregnancy.

Device Description

The ACRO HCG Pregnancy Rapid Test is designed to be tested in midstream mode. The ACRO HCG Pregnancy Rapid Test consists of a single test strip encased in plastic device housing, with or without an additional absorbent tip. The result is generated by immersing the tip in the urine stream for a sufficient amount of time to absorb an adequate sample volume. It is a rapid, one-step chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the detection of pregnancy. The test utilizes a combination of antibodies including a monoclonal hCG antibody to selectively detect elevated levels of hCG.

AI/ML Overview

The ACRO HCG Pregnancy Rapid Test is a consumer-use device for the visual qualitative detection of Human Chorionic Gonadotropin (hCG) in urine to detect pregnancy.

Here's an analysis of its acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Intended Use	Rapid qualitative detection of hCG to aid in the early detection of pregnancy.
Cutoff	25 mIU/mL
Test Principle	Lateral flow Sandwich Immunochromatographic Assay
Positive Result	2 colored lines
Negative Result	1 colored line
Detection Reagent	Colloidal gold
Specificity	Negative at: hLH: 500mIU/ml hFSH: 1000mIU/mL hTSH: 1000 µIU/mL
Traceability	WHO 4th International Standard
Critical Raw Materials (source) and Preparation Formulas	Antibody and Antigen Nitrocellulose Membrane Colloidal Gold Conjugate Pad Sample Pad
Component Strip	Width and Length
Critical Production Process	Membrane spray/coating Conjugate Pad Sample pad treatment
Storage Temperature	35 – 86°F (2 – 30 °C)
Read Time	3 to 10 minutes
Device Format	Midstream without Absorbent Tip and Midstream with Absorbent Tip
Verification and Validation	Lay user performance, Precision, Time Flex, Storage, and Stability Studies were conducted and passed acceptance criteria.

2. Sample Size for the Test Set and Data Provenance

The provided document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "Lay user performance, Precision, Time Flex, Storage and Stability Studies were conducted and passed acceptance criteria."

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

This information is not provided in the document. The document refers to "Lay user performance" studies, which implies testing by intended users rather than experts establishing a ground truth for diagnostic accuracy. For an OTC device like a pregnancy test, the "ground truth" for lay user performance typically involves whether the user can correctly interpret the test result based on provided instructions, not necessarily the diagnostic accuracy of the device against a clinical "gold standard."

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of a rapid pregnancy test designed for consumer use, and the absence of specific details on expert interpretation, it's unlikely a formal adjudication method by multiple experts was employed for user performance studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This question is not applicable to the ACRO HCG Pregnancy Rapid Test. This device is a standalone in-vitro diagnostic test, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The ACRO HCG Pregnancy Rapid Test is a standalone device in the sense that its result is determined by chemical reaction and visual interpretation by the user. There is no "algorithm only" component or AI involved. The "standalone" performance here refers to the device's inherent ability to detect hCG accurately without further human intervention beyond performing the test and reading the results. The document implies this through the "Precision, Storage and Stability Studies."

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the performance studies (Precision, Specificity, etc.), the ground truth would likely be established through:

Known concentrations: For precision and specificity, controlled urine samples with known hCG levels (including negative controls and samples spiked with interfering substances like hLH, hFSH, hTSH) would be used.
WHO 4th International Standard: The document explicitly mentions "WHO 4th International Standard" for traceability, indicating that the device's performance is aligned with a recognized international standard for hCG measurement.

For the "Lay user performance" studies, the "ground truth" would likely be based on comparison with the manufacturer's expected result for the tested samples, and the user's ability to correctly obtain and interpret that result according to the instructions.

8. The Sample Size for the Training Set

This information is not applicable as the ACRO HCG Pregnancy Rapid Test is a chemical assay, not a machine learning or AI-driven device that requires a training set in that context.

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

This information is not applicable for the same reason as point 8.

Summary

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February 2, 2018

ACRO Biotech, Inc. % Feng-Yu Lee Principal Regulatory Consultant IVDD Regulatory Consultant 29222 Rancho Viejo Road, Suite 218 San Juan Capistrano, CA 92675

Re: K172512

Trade/Device Name: ACRO HCG Pregnancy Rapid Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: January 12, 2018 Received: January 26, 2018

Dear Feng-Yu Lee:

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. 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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR

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Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Kellie B. Kelm -S

for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172512

Device Name ACRO HCG Pregnancy Rapid Test

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

X 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: K172512

1. Submitter's Identification: Acro Biotech, Inc 9500 Seventh Street, Suite M Rancho Cucamonga, CA 91730 Phone Number: 1-909-4666892 FAX Number: 1-909-4666892
  c/o IVDD Regulatory Consultant 29222 Rancho Viejo Road, Suite 218 San Juan Capistrano, CA 92675 Contact Person: Feng-Yu Lee Phone Number: 1-949-218-0929 Fax Number: 1-949-218-0928

Date Summary Prepared: February 2nd, 2018

1. Name of the Device: ACRO HCG Pregnancy Rapid Test,
1. Common or Usual Name: Blood Glucose Monitoring System

Product Code	Classification	Regulation Section	Panel
LCX; Kit, Test,Pregnancy, HCG, Over-the-Counter	Class II	21 CFR 862.1155Human Chorionic Gonadotropin(HCG) test system	ClinicalChemistry 75

4. Device Description:

1. Intended Use:

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Acro Biotech, Inc

1. Predicate Device Information:
  The subject devices are substantially equivalent to the brand of Rightest Blood Glucose Monitoring System noted below.

MiniStick Pregnancy Test Name: Device Company: ACRO Biotech, Inc. 510(K) Number: K960733

1. Comparison to Predicate Devices:
  The ACRO HCG Pregnancy Rapid Test is a modified model of a cleared device, the MiniStick Pregnancy Test, K960733. The changes to the cleared device include addition of an absorbent tip, result reading time and device storage condition.

There is no change to the indications for use nor to the fundamental scientific technology of the device.

Similarities
Item	Candidate	Predicate Device (K960733)
Intended Use	Rapid qualitative detection ofhCG to aid in the early detectionof pregnancy.	Same
Cutoff	25 mIU/ml	Same
Test Principle	Lateral flow SandwichImmunochromatographic Assay	Same
Positive result	2 colored lines	Same
Negative result	1 colored line	Same
Detection reagent	Colloidal gold	Same
Specificity	Negative at:hLH: 500mIU/mlhFSH: 1000mIU/mLhTSH: 1000 $ \mu $ IU/mL	Same
Traceability	WHO 4th International Standard	Same
Critical RawMaterials (source)and PreparationFormulas	Antibody and AntigenNitrocellulose MembraneColloidal Gold Conjugate PadSample Pad	Same
Component Strip	Width and Length	Same
Critical ProductionProcess	Membrane spray/coatingConjugate PadSample pad treatment	Same

Substantial Equivalence Comparison

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	Differences
Storage Temperature	35 - 86°F (2 – 30 °C)	Below 86°F (30 °C)
Read time	3 to 10 minutes	After 5 minutes
Device Format	Midstream without Absorbent TipandMidstream with Absorbent Tip	Midstream without Absorbent Tip

1. Summary of Verification and Validation activities Lay user performance, Precision, Time Flex, Storage and Stability Studies were conducted and passed acceptance criteria to support the changes.

9. Conclusions from Verification and Validation Activities:

The results of all verification and validation activities demonstrate that the candidate device is substantially equivalent to the cleared predicate MiniStick Pregnancy Test (K960733). The differences between the modified device and the cleared predicate device do not raise any new issue of safety and effectiveness.

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.