ONE-STEP DOUBLE-CHEK PREGNANCY TEST

K992915 · Biomedical Products Corp. · JHI · Nov 18, 1999 · Clinical Chemistry

Device Facts

• Record ID: K992915
• Device Name: ONE-STEP DOUBLE-CHEK PREGNANCY TEST
• Applicant: Biomedical Products Corp.
• Product Code: JHI · Clinical Chemistry
• Decision Date: Nov 18, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The One-Step Double-Chek™ Pregnancy Test is a test for the qualitative determination of human chorionic gonadotropin (hCG) in urine and serum, for the early detection of pregnancy. For Laboratory Professional Use Only.

Device Story

The One-Step Double-Chek™ Pregnancy Test is an in vitro diagnostic device for detecting hCG in urine or serum samples. It utilizes a lateral flow immunoassay principle: a combination of monoclonal-dye conjugate and polyclonal-solid phase antibodies. When a sample is applied, the antibody-dye conjugate binds to hCG, forming a complex that migrates to a reaction zone. If hCG concentration is ≥25 mIU/ml, the complex binds to anti-hCG antibodies, producing a visible pink-rose color band. A control zone confirms reagent function via unbound conjugate. The test is intended for professional use in a laboratory environment by trained technicians. Results are interpreted visually by the clinician to confirm pregnancy, often in conjunction with physical examination or ultrasound. The device provides a rapid, qualitative assessment to aid in clinical decision-making regarding pregnancy status.

Clinical Evidence

Clinical trial comparing the One-Step Double-Chek™ Pregnancy Test to the Abbott TestPack Plus. Study performed by trained laboratory technicians in a CLIA-registered laboratory. Results showed 100% sensitivity, 100% specificity, and 100% agreement. Pregnancy results were confirmed via physical examination and/or ultrasound.

Technological Characteristics

Lateral flow immunoassay; utilizes monoclonal-dye conjugate and polyclonal-solid phase antibodies. Detects hCG at a threshold of 25 mIU/ml. Visual readout via pink-rose color bands in reaction and control zones. No electronic components or software.

Indications for Use

Indicated for the qualitative determination of human chorionic gonadotropin (hCG) in urine and serum for the early detection of pregnancy in professional laboratory settings.

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.

Predicate Devices

• Abbott TestPack Plus

Submission Summary (Full Text)

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# 510 (K) SUMMARY

Date of Summary: October 7, 1999

# Product Name:

One-Step Double-Chek™ Pregnancy Test

### Sponsor:

Bio-Medical Products Corp. 10 Halstead Road Mendham, NJ 07945

### Correspondent:

MDC Associates Fran White Regulatory Consultant 15 Oak Street Beverly Farms, MA 01915

#### Substantially Equivalent Devices:

Product: Abbott TestPack Plus Manufactured by: Abbott Diagnostics

### PRODUCT DESCRIPTION:

The One-Step Double-Chek™ Pregnancy Test is to be used for detecting human Chorionic Gonadotropin (hCG) in urine and serum. The presence of hCG usually appears about the seventh day after fertilization. The One-Step Double-Chek™ Pregnancy Test will detect hCG in urine and serum at a concentration level of 25 mIU/ml. The One-Step Double-Chek™ Pregnancy Test will be sold for professional use only.

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### INTENDED USE:

The One-Step Double-Chek™ Pregnancy Test is a test for the qualitative determination of human chorionic gonadotropin (hCG) in urine and serum, for the early detection of pregnancy. For Laboratory Professional Use Only.

# SUMMARY OF TECHNOLOGY:

The One-Step Double-Chek™ Pregnancy Test employs a unique combination of monoclonaldye conjugate and polyclonal-solid phase antibodies to selectively identify human Chorionic Gonadotropin (hCG) in urine and serum. As the urine or serum sample flows through the absorbent portion of the device, the antibody-dye conjugate binds to the hCG forming an antibody-antigen complex. This complex binds to the anti-hCG antibody in the positive reaction zone and produces a pink-rose color band if hCG concentration is equal to or greater than 25 mIU/ml. In the absence of hCG, there is no line in the reaction zone. Unbound conjugate binds to the reagents in the control zone, producing a pink-rose color band. demonstrating that the reagents are functioning correctly.

# PERFORMANCE DATA:

A clinical trial was done to compare the performance of the One-Step Double-Chek™ Pregnancy Test. These data clearly demonstrates the performance of the One-Step Double-Chek ™ Pregnancy Test by Bio-Medical is substantially equivalent to the Abbott TestPack Plus TM.

| Sensitivity = | 100% |
|---------------|------|
| Specificity = | 100% |
| Agreement = | 100% |

# STATEMENT OF SAFETY AND EFFICACY:

The One-Step Double-Chek™ Pregnancy Test when compared with another commonly used pregnancy test (Abbott TestPack Plus) demonstrated 100% performance.

All pregnancy results were confirmed by physical examination and/or ultrasound.

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These data clearly demonstrate the safety and efficacy of the One-Step Double-Chek Pregnancy Test and further confirm that the accuracy, sensitivity and specificity of this product when compared to a substantially equivalent device currently being sold for professional use. A trained Laboratory Technician performed testing in a CLIA registered laboratory.

Bio-Medical Products Corporation confirms that any/all data provided in this submission may be released upon request.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 1 8 1999

Biomedical Products Corporation c/o Ms. Fran White MDC Associates 15 Oak Street Beverly Farms, Massachusetts 01915

K992915 Re:

> Trade Name: One-Step Double-ChekTM Pregnancy Test Regulatory Class: II Product Code: JHI Dated: October 7, 1999 Received: October 21, 1999

Dear Ms. White:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Putman

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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Page 18 of 29

510(k) Number: (if known) K992915
Device Name: One-Step Double-Chek™ Pregnancy Test

#### Indication for Use:

The One-Step Double-Chek™ Pregnancy Test is a test for the qualitative determination of human chorionic gonadotropin (hCG) in urine and serum, for the early detection of pregnancy. For Laboratory Professional Use Only.

Stan Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 16992915

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

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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)