Acro HCG Pregnancy Rapid Test

K180771 · Acro Biotech, Inc. · LCX · May 18, 2018 · Clinical Chemistry

Device Facts

• Record ID: K180771
• Device Name: Acro HCG Pregnancy Rapid Test
• Applicant: Acro Biotech, Inc.
• Product Code: LCX · Clinical Chemistry
• Decision Date: May 18, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

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.

Device Story

Rapid, one-step chromatographic immunoassay for qualitative detection of hCG in urine; aids in early pregnancy detection. Device consists of test strip in plastic housing, with or without absorbent tip. User performs test via midstream (urine stream) or dip mode (immersion). Principle of operation: lateral flow sandwich immunochromatographic assay using colloidal gold-labeled monoclonal hCG antibodies. Visual output: 2 colored lines indicate positive result; 1 colored line indicates negative result. Read time: 3 to 10 minutes. Intended for home use by lay consumers.

Clinical Evidence

Bench testing only. Verification and validation activities included lay user performance, precision, time flex, and storage/stability studies. All studies passed acceptance criteria.

Technological Characteristics

Lateral flow sandwich immunochromatographic assay. Materials: test strip, plastic housing, absorbent tip. Detection: colloidal gold chromophore. Cutoff: 25 mIU/mL. Traceability: WHO 4th International Standard. Storage: 2-30°C. Manual visual read. No electronic components or software.

Indications for Use

Indicated for over-the-counter use by consumers for visual qualitative detection of hCG in urine to aid in early pregnancy detection.

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

• ACRO HCG Pregnancy Rapid Test (k172512)

Submission Summary (Full Text)

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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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

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.

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

- 2. Name of the Device: ACRO HCG Pregnancy Rapid Test
- 3. Common or Usual Name: Blood Glucose Monitoring System

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

#### 4. 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.

- 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.

- 6. 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

- 7. 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 of<br>hCG to aid in the early detection<br>of pregnancy. | Same |
| Cutoff | 25 mIU/ml | Same |
| Test Principle | Lateral flow Sandwich<br>Immunochromatographic Assay | Same |
| Positive result | 2 colored lines | Same |
| Negative result | 1 colored line | Same |
| Detection reagent | Colloidal gold | Same |
| Specificity | Negative at:<br>hLH: 500mIU/ml<br>hFSH: 1000mIU/mL<br>hTSH: 1000 µIU/mL | Same |
| Traceability | WHO 4th International Standard | Same |
| Critical Raw | Antibody and Antigen | Same |
| Materials (source)<br>and Preparation<br>Formulas | Nitrocellulose Membrane<br>Colloidal Gold Conjugate Pad<br>Sample Pad | |
| Component Strip | Width and Length | Same |
| Critical Production<br>Process | Membrane spray/coating<br>Conjugate Pad<br>Sample 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 without<br>Absorbent Tip | Same |
|----------------|--------------------------------------------|------|
|----------------|--------------------------------------------|------|

| Differences | | |
|--------------------|-----|----|
| Dip Mode Procedure | Yes | No |

- 8. 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).