MAINLINE MAXIE HCG URINE PREGNANCY TEST

K031445 · Mainline Technology, Inc. · JHI · Jul 1, 2003 · Clinical Chemistry

Device Facts

• Record ID: K031445
• Device Name: MAINLINE MAXIE HCG URINE PREGNANCY TEST
• Applicant: Mainline Technology, Inc.
• Product Code: JHI · Clinical Chemistry
• Decision Date: Jul 1, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Indications for Use

The Mainline Maxie hCG-Urine is a one-step immunoassay for the rapid qualitative determination of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy at a cut off concentration of 20 mIU/ml. This kit is used to obtain a visual result and is intended for professional and laboratory use.

Device Story

Maxie hCG Urine is a one-step lateral flow immunoassay for qualitative detection of hCG in urine. Device utilizes immunochromatographic technology to provide visual results. Intended for professional and laboratory use for early pregnancy detection. Operator applies urine sample to test device; presence of hCG is indicated by visual color change. Results assist clinicians in confirming pregnancy status.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

One-step lateral flow immunoassay; qualitative visual readout; cut-off sensitivity 20 mIU/ml hCG.

Indications for Use

Indicated for the early detection of pregnancy in urine samples. Intended for professional and laboratory use. Cut-off concentration is 20 mIU/ml.

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

Food and Drug Administration
2098 Gaither Road
Rockville MD 20850

Ms. Martha Mazurek
President
Mainline Technology Inc.
3985 Research Park Drive
Ann Arbor, MI 48108

Re: k031445
Trade/Device Name: Maxie hCG Urine
Regulation Number: 21 CFR 862.1155
Regulation Name: Human chorionic gonadotropin (HCG) test system
Regulatory Class: Class II
Product Code: JHI
Dated: April 3, 2003
Received: May 7, 2003

JUL 1 2003

Dear Ms. Mazurek:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven I. Gutman, M.D., M.B.A.
Director
Office of In Vitro Diagnostic Device
Evaluation and Safety
Center for Devices and
Radiological Health

Enclosure

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Ver/ 3 - 4/24/96

Applicant: Mainline Technology, Inc.

510(k) Number (if known): K031445

Device Name: Maxie hCG Urine

Indications For Use:

The Mainline Maxie hCG-Urine is a one-step immunoassay for the rapid qualitative determination of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy at a cut off concentration of 20 mIU/ml. This kit is used to obtain a visual result and is intended for professional and laboratory use.


Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K031445

(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)

(Optional Format 1-2-96)

Over-the-Counter Use