AMEDITECH IMMUTEST HCG PREGANCY TEST

K023126 · Ameditech, Inc. · LCX · Nov 18, 2002 · Clinical Chemistry

Device Facts

• Record ID: K023126
• Device Name: AMEDITECH IMMUTEST HCG PREGANCY TEST
• Applicant: Ameditech, Inc.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Nov 18, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The Ameditech ImmuTest™ hCG Pregnancy Test is an In Vitro diagnostic test for the qualitative detection of hCG in human urine to aid in the early detection of pregnancy. The sensitivity of the ImmuTest™ hCG Pregnancy Test is 25 mIU/ml hCG. This test kit is used to obtain a visual, qualitative result and is intended for professional and Over-the-Counter uses.

Device Story

Ameditech ImmuTest™ hCG Pregnancy Test is an in vitro diagnostic device; detects human chorionic gonadotropin (hCG) in human urine samples. Principle of operation: lateral flow immunoassay; provides visual qualitative results. Used in professional clinical settings and by consumers (Over-the-Counter). Output: visual color change indicating presence or absence of hCG at 25 mIU/ml sensitivity. Assists healthcare providers and patients in early pregnancy confirmation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Lateral flow immunoassay; qualitative visual readout; sensitivity 25 mIU/ml hCG. Device is a standalone test kit.

Indications for Use

Indicated for qualitative detection of hCG in human urine to aid in early pregnancy detection. Intended for professional and Over-the-Counter use.

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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Food and Drug Administration 098 Gaither Road Rockville MD 20850

NOV 1 8.2002

John Wu. Ph.D. Director of Ouality Assurance Ameditech, Inc. 10340 Camino Santa Fe, Suite F San Diego, CA 92121

> k023126 Trade/Device Name: Ameditech ImmuTest™ hCG Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX; JHI Dated: September 16, 2002 Received: September 19, 2002

Dear Dr. Wu:

Re:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrl/dsmaldsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment A

Revised Indications for Use Form

510(k) Number (if known):

Ameditech ImmuTest™ hCG Pregnancy Test Device Name:

2023121,

Indications For Use:

The Ameditech ImmuTest™ hCG Pregnancy Test is an In Vitro diagnostic test for the qualitative detection of hCG in human urine to aid in the early detection of pregnancy. The sensitivity of the ImmuTest™ hCG Pregnancy Test is 25 mIU/ml hCG.

This test kit is used to obtain a visual, qualitative result and is intended for professional and Over-the-Counter uses.

(Division Sign-Off)
Division of Clinical Laboratd
510(k) Number K03120

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
✓

OR

Over-The-Counter Use
(Optional Format 1-2-96)

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