HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE) by HEALGEN SCIENTIFIC, LLC

The Healgen hCG One Step Pregnancy Test Strip is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. Urine sample collected with cup only. For Over-The-Counter self-testing use.

The Healgen hCG One Step Pregnancy Test Cassette is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. Urine sample collected with cup only. For Over-The-Counter self-testing use.

Device Description

Not Found

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for the Healgen hCG One Step Pregnancy Test Strip and Cassette. It confirms substantial equivalence to a predicate device but does not contain the detailed study information, acceptance criteria, or performance data that would typically be found in the actual 510(k) submission or a scientific publication.

Therefore, I cannot fully answer your request with the input provided. However, I can infer some aspects based on common FDA requirements for such devices.

Here's what can and cannot be answered based on the provided text:

What can be extracted:

Device Name: Healgen hCG One Step Pregnancy Test Strip, Healgen hCG One Step Pregnancy Test Cassette
Indications for Use: Rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy, for Over-The-Counter self-testing use.
Type of Test: In vitro diagnostic visual qualitative immunochromatographic assay.

What cannot be extracted from the provided text:

A table of acceptance criteria and the reported device performance: This information is not present in the FDA clearance letter. It would be in the detailed device performance section of the 510(k) submission. Acceptance criteria for pregnancy tests typically include sensitivity (limit of detection, analytical sensitivity), accuracy (agreement with a reference method), and sometimes precision.
Sample size used for the test set and the data provenance: Not available in this document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available. For an OTC pregnancy test, ground truth is usually based on a quantitative lab reference method for hCG.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable or not available.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Highly unlikely for a qualitative, visually read OTC pregnancy test. This type of study is more common for imaging devices or algorithms that interpret complex data. The performance would be assessed against a quantitative standard, not typically human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a visual qualitative assay, meaning a human reads the result directly. It's not an algorithm.
The type of ground truth used: For a pregnancy test, the ground truth for hCG detection is typically established by a quantitative laboratory method (e.g., quantitative serum or urine hCG assay) to determine the precise hCG concentration.
The sample size for the training set: Not applicable for this type of device. There isn't an "algorithm" or "AI" that requires a training set in the conventional sense for a visual immunochromatographic assay.
How the ground truth for the training set was established: Not applicable for the same reason as above.

To obtain this detailed information, one would need to review the actual 510(k) submission (if it's publicly available and unredacted) or scientific publications related to the device's validation.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of an eagle or bird-like figure with three curved lines extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 10, 2013

Healgen Scientific, LLC C/O Bryan Fang 3818 Fuqua Street HOUSTON TX 77401

Re: K123703

Trade/Device Name: Healgen hCG One Step Pregnancy Test Strip Healgen hCG One Step Pregnancy Test Cassette Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: II Product Code: LCX Dated: February 08, 2013 Received: March 12, 2013

Dear Mr. Fang:

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); medical device reporting (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.

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Page 2-Mr. Fang

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Carol C. Benson -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): K123703

Device Name:

Healgen hCG One Step Pregnancy Test Strip Healgen hCG One Step Pregnancy Test Cassette

Indications for Use:

Prescription Use (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use _ X (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Denise Johnson-lyles -S 2013.04.09 09:40:45 -04'00'

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k)_k123703

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.