CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY

K032159 · Access Bio Incorporate · LCX · Sep 5, 2003 · Clinical Chemistry

Device Facts

• Record ID: K032159
• Device Name: CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY
• Applicant: Access Bio Incorporate
• Product Code: LCX · Clinical Chemistry
• Decision Date: Sep 5, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The Care Start™ Pregnancy Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. The test is intended for over-the-counter sale to laypersons.

Device Story

Lateral flow immunochromatographic assay; detects hCG in urine. Device consists of test stick with absorbent tip, results window, and thumb grip. User places absorbent tip in urine stream or dips into collection cup. Principle: hCG in sample reacts with anti-hCG dye conjugate and immobilized anti-hCG to form visible pink line in test area; control line confirms test validity. Read time 3-10 minutes. Intended for over-the-counter home use. Provides qualitative result (positive/negative) to assist in pregnancy determination.

Clinical Evidence

Method comparison study performed with 115 samples comparing Care Start™ Pregnancy Test to predicate device. Results showed 100% concordance (46 positive, 69 negative). Analytical specificity confirmed with various common urine analytes and pH levels. Calibration performed against WHO Standard (4th IS 75/589).

Technological Characteristics

Lateral flow immunochromatographic assay; qualitative visual readout; urine specimen; non-instrumented.

Indications for Use

Indicated for laypersons for the qualitative detection of hCG in urine for early pregnancy detection.

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

Public Health Service

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SEP - 5 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Young Ho Choi Director Access Bio. Inc. 675 U.S. Highway 1 North Brunswick, NJ 08902

k032159 Re: Trade/Device Name: CareStart™ Pregnancy Test CareStart PLUSTM Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: June 25, 2003 Received: July 15, 2003

Dear Mr. Choi:

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. Iisting 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 Butman

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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## INDICATIONS FOR USE STATEMENT

Ver/ 3 - 4/24/96

Applicant: Access Bio Inc.

510(k) Number (if known): New Application - Ko3 2159

CareStart™ Pregnancy Test Device Name: CareStart PLUSTM Pregnancy Test

## Indications For Use:

CareStart™ Pregnancy Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. The test is intended for over-the counter sale to laypersons.

Carol C Benen for Jean Cooper, DVM
**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K032159

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use ( | ) |
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or

| Over-The-Counter Use( | X ) |
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(Per 21 CFR 801.109)

(Optional Format 1-2-96)