HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE)

K123703 · Healgen Scientific,, LLC · LCX · Apr 10, 2013 · Clinical Chemistry

Device Facts

• Record ID: K123703
• Device Name: HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE)
• Applicant: Healgen Scientific,, LLC
• Product Code: LCX · Clinical Chemistry
• Decision Date: Apr 10, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

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 Story

Rapid sandwich immunoassay for qualitative hCG detection in human urine; aids early pregnancy detection. Device formats include test strip and cassette. Principle: lateral flow immunochromatographic sandwich assay; urine sample reacts with mouse anti-hCG antibody-colloidal gold conjugate; mixture migrates via capillary action to membrane pre-coated with monoclonal anti-hCG antibodies (test band) and anti-mouse antibodies (control band). Red band appearance in test region indicates positive result; absence indicates negative. Control band confirms proper flow. Used in home setting by lay users; self-administered. Results interpreted visually by user. Provides rapid pregnancy status confirmation to inform clinical follow-up.

Clinical Evidence

No clinical data provided; device relies on bench testing for performance validation as an immunochromatographic assay.

Technological Characteristics

Lateral flow immunochromatographic sandwich assay. Membrane pre-coated with monoclonal anti-hCG antibodies and anti-mouse antibodies. Reagents: mouse anti-hCG antibody-colloidal gold conjugate. Formats: test strip and cassette. Qualitative visual readout. No instrumentation required. Quality management per ISO 13485; risk management per ISO 14971.

Indications for Use

Indicated for the rapid, qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in early pregnancy detection. Intended for over-the-counter (OTC) self-testing by individuals using cup-collected urine samples.

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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## 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 [phone] or [phone] 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:

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.

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