ONE STEP HCG PREGNANCY URINE TEST FORMATS: STRIP, CASSETTE AND MIDSTREAM, MODELS BM-1-1, BM-1-2, BM-1-3, BM-2-1, BM-2-2

K050305 · Bioscreen Medical, Inc. · LCX · May 23, 2005 · Clinical Chemistry

Device Facts

• Record ID: K050305
• Device Name: ONE STEP HCG PREGNANCY URINE TEST FORMATS: STRIP, CASSETTE AND MIDSTREAM, MODELS BM-1-1, BM-1-2, BM-1-3, BM-2-1, BM-2-2
• Applicant: Bioscreen Medical, Inc.
• Product Code: LCX · Clinical Chemistry
• Decision Date: May 23, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The One Step hCG Pregnancy Urine Test (strip, cassette, and midstream format) is a rapid one step test for the qualitative detection of human chorionic gonadotropin (hCG) in urine. For over-the-counter in vitro diagnostic use. The One Step hCG Pregnancy Urine Test Strip is a rapid one step test for the qualitative detection of human chorionic gonadotropin (hCG) in urine. For professional in vitro diagnostic use only. The One Step hCG Pregnancy Urine/Serum Test Strip is a rapid one step test for the qualitative detection of human chorionic gonadotropin (hCG) in urine and serum. For professional in vitro diagnostic use only. The One Step hCG Pregnancy Urine Test Cassette is a rapid one step test for the qualitative detection of human chorionic gonadotropin (hCG) in urine. For professional in vitro diagnostic use only. The One Step hCG Pregnancy Urine/Serum Test Cassette is a rapid one step test for the qualitative detection of human chorionic gonadotropin (hCG) in urine and serum. For professional in vitro diagnostic use only.

Device Story

Rapid chromatographic immunoassay for qualitative hCG detection in urine or serum; utilizes goat anti-mouse IgG, mouse monoclonal anti-hCG antibody A, and colloidal gold-conjugated monoclonal anti-hCG antibody B. Sample migrates via capillary action; hCG binds antibodies to form pink-colored lines on membrane. Formats include strip, cassette, and midstream. Used in clinical settings by professionals or at home by lay users. Visual interpretation of lines indicates pregnancy status; aids clinical decision-making regarding pregnancy confirmation. Benefits include rapid, simple, point-of-care detection of hCG.

Clinical Evidence

Bench testing only. Analytical sensitivity evaluated using 120 spiked samples (0-100 mIU/mL); cutoff established at 20 mIU/mL. Specificity confirmed against LH, FSH, TSH, and common interfering substances. Method comparison with predicate showed 98-99% agreement in professional settings. Consumer usability study (n=5 lay persons, 120 tests) demonstrated 96.7% overall accuracy and 86.7% accuracy at the 20 mIU/mL cutoff.

Technological Characteristics

Lateral flow immunoassay; two-site sandwich format; qualitative visual readout; strip, cassette, and midstream form factors.

Indications for Use

Indicated for qualitative detection of hCG in urine or serum as an aid in early pregnancy detection. Intended for OTC use (urine test) and professional use (urine/serum tests).

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

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dr. Jimmy Liang General Manger Bioscreen Medical Inc. RR1 Box 1045A Mildred, PA 18632

MAY 2 3 2005

k050305 Re:

Trade/Device Name: One Step hCG Pregnancy Urine Test Formats: Strip, Cassette and Midstream One Step hCG Pregnancy Urine/Serum Test Formats: Strip and Cassette Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system

Regulatory Class: Class II Product Code: JHI, LCX Dated: April 11, 2005 Received: April 11, 2005

Dear Dr. Liang:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 31 (a) } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorosale) to regally the Medical Device Amendments, or to conniferee prior to May 20, 1776, the encordance with the provisions of the Federal Food, Drug, devices that have been roomstiled in wore approval of a premarket approval application (PMA). alla Cosmetic Act (71ct) that do novice, subject to the general controls provisions of the Act. The Tournal controls provisions of the Act include requirements for annual registration, listing of general controls provisions of mactice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (dos as o) trols. Existing major regulations affecting your device It may be subject to Such additions comise reservlations (CFR), Parts 800 to 895. In addition, FDA can oc found in Ther 21, Courcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I least be advised that I Dris assumes a your device complies with other requirements of the Act that I DA has made a decermination administered by other Federal agencies. You must of any I cutures and regaranents, including, but not limited to: registration and listing (21 comply with an the Ave STequirements 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) I his letter will anow you to begin marketing your ntial equivalence of your device to a legally premarket notification. The I Driving or between 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, If you desire specific information advartising of your device, please contact the Office of In of questions on the promotion and Safety at [phone]. Also, please note the VINO Diagnostic Dortos Drailian by reference to premarket notification" (21 CFR Part 807.97). Tegulation chitted, "Misoranant on your responsibilities under the Act from the You may outlif onlici general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Carol C. Benem

Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

## 510(k) Number (if known): K050305

| Device Name: | One Step hCG Pregnancy Urine Test |
|--------------|-----------------------------------|
| Formats: | Strip, Cassette and Midstream |

Indications For Use:

One Step hCG Pregnancy Urine Test device is a qualitative, two sites sandwich immunoassay test device designed for the determination of human chorionic gonadotropin (hCG) concentration in urine samples, and therefore is an aid in the early detection of pregnancy. These test devices available in strip, cassette and midstream formats are intended for overthe-counter (OTC) use. The test devices in cassette and strip format are for professional use as well. For in-vitro diagnostic use only.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ x (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) sille

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k)

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## Indications for Use

### 510(k) Number (if known): K050305

One Step hCG Pregnancy Urine/Serum Test Device Name: Formats: Strip and Cassette

One Step hCG Pregnancy Urine/Serum Test device is a Indications For Use: qualitative, two sites sandwich immunoassay test device designed for the determination of human chorionic gonadotropin (hCG) concentration in urine and serum samples, and therefore is an aid in the early detection of pregnancy. These test devices available in strip and cassette formats are intended for professional use only. For in-vitro diagnostic use only.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Rute Chelen

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Ko50305 510(k) -

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