CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST

K031048 · Access Bio Incorporate · JHI · Jun 16, 2003 · Clinical Chemistry

Device Facts

• Record ID: K031048
• Device Name: CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST
• Applicant: Access Bio Incorporate
• Product Code: JHI · Clinical Chemistry
• Decision Date: Jun 16, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

CareStart™ hCG Combo One Step Pregnancy Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum for the early detection of pregnancy. The test is intended for use by health care professionals.

Device Story

CareStart™ hCG Combo One-Step Pregnancy Test is an in vitro diagnostic device for qualitative detection of hCG in urine or serum samples. Used by healthcare professionals in clinical settings for early pregnancy detection. Operates via lateral flow immunoassay technology; sample applied to test device; hCG binds to specific antibodies; visual color change indicates presence of hCG. Provides rapid qualitative results to assist clinicians in confirming pregnancy status.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and technological characteristics.

Technological Characteristics

Lateral flow immunoassay; qualitative detection of hCG; urine or serum sample matrix; visual readout; standalone test device.

Indications for Use

Indicated for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum for the early detection of pregnancy in patients by healthcare professionals.

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 1 6 2003

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

k031048 Re:

Trade/Device Name: CareStart™ hCG Combo One-Step Pregnancy Test CareStart Plus - hCG Combo One-Step Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI Dated: March 31, 2003 Received: April 16, 2003

Dear Mr. Young Ho 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

and the colling consistence of the program and the commend of commend and and and Ver/ 3 - 4/24/96

Applicant: Access Bio Inc.

510(k) Number (if known): New Application

Device Name: CareStart™ hCG Combo One-Step Pregnancy Test CareStart Plus -- hCG Combo One-Step Pregnancy Test

Indications For Use:

CareStart™ hCG Combo One Step Pregnancy Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum for the early detection of pregnancy. The test is intended for use by health care professionals.

Alan Cooper

**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K031048

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Over-The-Counter Use(

(Per 21 CFR 801.109)

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