K Number

Device Name

ACRO HCG Pregnancy Rapid Test

Manufacturer

ACRO Biotech, Inc.

Date Cleared

2018-02-02

(165 days)

Product Code

LCX

Regulation Number

862.1155

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K960733

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a rapid immunoassay test that relies on chemical reactions and visual interpretation, with no mention of AI or ML technologies.

Therapeutic

No
The device is a diagnostic tool used to detect pregnancy, not to treat or cure a disease or condition.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "used to detect the pregnancy of HCG in urine as an indication of pregnancy," which is a diagnostic purpose.

SaMD (Software as a Medical Device)

The device description clearly states it consists of a physical test strip encased in plastic housing, which is a hardware component. It is a rapid immunoassay, not a software application.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states it's for the "visual qualitative detection of Human Chorionic Gonadotropin (hCG) in urine." This is a test performed on a sample taken from the body (urine) to provide information about a physiological state (pregnancy).
Device Description: The description details a "chromatographic immunoassay" that detects a specific substance (hCG) in a biological sample (urine). This is a common method used in IVD tests.
Sample Type: The test uses urine, which is a biological sample.
Purpose: The purpose is to "aid in the detection of pregnancy," which is a diagnostic purpose.

The fact that it's used by a consumer for over-the-counter use doesn't change its classification as an IVD. Many IVDs are designed for home use.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

LCX

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

consumer / Over-The-Counter Use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Lay user performance, Precision, Time Flex, Storage and Stability Studies were conducted and passed acceptance criteria to support the changes.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Specificity: Negative at: hLH: 500mIU/ml, hFSH: 1000mIU/mL, hTSH: 1000 micro IU/mL

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K960733

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

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

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)
-------------------------------------------------	--

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
LCX; Kit, Test,
Pregnancy, HCG, Over-
the-Counter	Class II	21 CFR 862.1155
Human Chorionic Gonadotropin
(HCG) test system	Clinical
Chemistry 75

4. Device Description:

1. Intended Use:

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 of
hCG to aid in the early detection
of pregnancy.	Same
Cutoff	25 mIU/ml	Same
Test Principle	Lateral flow Sandwich
Immunochromatographic Assay	Same
Positive result	2 colored lines	Same
Negative result	1 colored line	Same
Detection reagent	Colloidal gold	Same
Specificity	Negative at:
hLH: 500mIU/ml
hFSH: 1000mIU/mL
hTSH: 1000 $ \mu $ IU/mL	Same
Traceability	WHO 4th International Standard	Same
Critical Raw
Materials (source)
and Preparation
Formulas	Antibody and Antigen
Nitrocellulose Membrane
Colloidal Gold Conjugate Pad
Sample Pad	Same
Component Strip	Width and Length	Same
Critical Production
Process	Membrane spray/coating
Conjugate Pad
Sample pad treatment	Same

Substantial Equivalence Comparison

	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 Tip
and
Midstream 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.