The ACRO hCG Pregnancy Rapid Test is for use by the over the counters for the visual qualitative detection of Human Chorionic Gonadotropin (hCG) in urine. It is to be used in either dip mode or midstream mode for the early detection of pregnancy.

Device Description

The ACRO HCG Pregnancy Rapid Test is designed to be tested in midstream mode and dip 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 qualitative immunoassay for the detection of human chorionic gonadotropin (hCG) in urine. It is intended for over-the-counter use for early detection of pregnancy in both dip mode and midstream mode.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The documents do not explicitly list formal "acceptance criteria" with numerical targets for clinical performance that would allow for a direct comparison table. However, it does state that "Lay user performance, Precision, Time Flex, Storage and Stability Studies were conducted and passed acceptance criteria". The provided comparison to the predicate device focuses more on technical specifications and design similarities.

The key performance characteristics implicitly demonstrated by the comparison to the predicate and the "passed acceptance criteria" for various studies are:

Performance Characteristic	Reported Device Performance
Cutoff	25 mIU/ml (Same as predicate)
Test Principle	Lateral flow Sandwich Immunochromatographic Assay (Same as predicate)
Positive Result	2 colored lines (Same as predicate)
Negative Result	1 colored line (Same as predicate)
Detection Reagent	Colloidal gold (Same as predicate)
Specificity	Negative at: hLH: 500mIU/ml, hFSH: 1000mIU/mL, hTSH: 1000 µIU/mL (Same as predicate)
Traceability	WHO 4th International Standard (Same as predicate)
Read Time	3 to 10 minutes (Same as predicate)
Lay User Performance	Passed acceptance criteria
Precision	Passed acceptance criteria
Time Flex	Passed acceptance criteria
Storage & Stability	Passed acceptance criteria
Dip Mode Procedure	Successfully added (Difference from predicate)

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

The documents do not specify the exact sample sizes for the "Lay user performance, Precision, Time Flex, Storage and Stability Studies."
The data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned.

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

This information is not provided in the supplied text. For a qualitative diagnostic test like this, ground truth would typically be established by a reference laboratory method (e.g., quantitative hCG measurement), not by a panel of experts.

4. Adjudication Method for the Test Set

This information is not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. This device is a standalone diagnostic test, not an AI-assisted interpretation tool for human readers.

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

Yes, the studies conducted (Lay user performance, Precision, Time Flex, Storage and Stability Studies) evaluate the performance of the device itself (standalone performance) as designed to be used by over-the-counter consumers. It is a rapid diagnostic test where the user visually interprets the results.

7. The Type of Ground Truth Used

While not explicitly stated for all studies, for a device detecting hCG, the ground truth would typically be established by:

Quantitative hCG measurement: Using a laboratory-based quantitative assay to determine the actual concentration of hCG in urine samples, which then serves as the reference standard for evaluating the rapid test's sensitivity and specificity at its stated cutoff (25 mIU/ml).
Clinical correlation/outcomes data: Confirmation of pregnancy via other clinical means for relevant samples.

8. The Sample Size for the Training Set

The concept of a "training set" is typically applicable to machine learning or AI models. This device is a lateral flow immunoassay, not an AI algorithm. Therefore, there is no "training set" in that context. The "development" or "optimization" of such a test involves various analytical studies, but not a dataset used to train an algorithm.

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

As there is no "training set" in the AI sense, this question is not applicable to this device. For the analytical studies and verification/validation, ground truth (e.g., known positive/negative hCG samples derived from quantitative methods) would have been used.

Summary

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May 18, 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: K180771

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: March 20, 2018 Received: March 23, 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 medical devices and radiation-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) K180771

Device Name ACRO HCG Pregnancy Rapid Test

Indications for Use (Describe)

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: K180771

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: May 17th, 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:

The ACRO HCG Pregnancy Rapid Test is designed to be tested in midstream mode and dip mode.

న. Intended Use:

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Acro Biotech, Inc

The ACRO hCG Pregnancy Rapid Test is for use by the over the counter consumers for the visual qualitative detection of Human Chorionic Gonadotropin (hCG) in urine. It is to be used in either dip mode or midstream mode for the early detection of pregnancy.

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

ACRO HCG Pregnancy Rapid Test Name: Device Company: ACRO Biotech, Inc. 510(K) Number: K172512

1. Comparison to Predicate Devices:
  The ACRO HCG Pregnancy Rapid Test is an identical device (with or without absorbent tip) of the cleared device, the ACRO HCG Pregnancy Rapid Test, K172512, with the additional dip mode testing procedure.

Substantial Equivalence Comparison

Similarities
Item	Candidate	Predicate Device (K172512)
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 µIU/mL	Same
Traceability	WHO 4th International Standard	Same
Critical Raw	Antibody and Antigen	Same
Materials (source)and PreparationFormulas	Nitrocellulose MembraneColloidal Gold Conjugate PadSample Pad
Component Strip	Width and Length	Same
Critical ProductionProcess	Membrane spray/coatingConjugate PadSample pad treatment	Same
Storage Temperature	35 - 86°F (2 – 30 °C)	Same
Read time	3 to 10 minutes	Same

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Acro Biotech, Inc

Device Formats	Midstream with or withoutAbsorbent Tip	Same
----------------	--------------------------------------------	------

Differences
Dip Mode Procedure	Yes	No

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 of K172512.

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 ACRO HCG Pregnancy Rapid Test (K172512).

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.