BLUETEST(R) PREGNANCY TEST, RAPIDVUE(R) PREGNANCY TEST

K974821 · Quidel Corp. · LCX · Jan 26, 1998 · Clinical Chemistry

Device Facts

• Record ID: K974821
• Device Name: BLUETEST(R) PREGNANCY TEST, RAPIDVUE(R) PREGNANCY TEST
• Applicant: Quidel Corp.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Jan 26, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The test is a rapid immunoassay for the qualitative detection of hCG in urine as an aid in the early detection of pregnancy. The test is intended for overthe counter home use.

Device Story

Bluetest/RapidVue Pregnancy Test is a lateral-flow, sandwich-format immunoassay for qualitative hCG detection in urine. Device utilizes monoclonal and polyclonal antibodies to detect hCG; presence of hCG produces a pink/blue plus sign (+) in result window; absence produces a blue minus sign (-). A blue line in control window validates test. Designed for over-the-counter home use by lay users. Provides rapid visual results to aid in early pregnancy detection. Performance validated via multi-center clinical study comparing results between lay users and clinic personnel, demonstrating equivalence to existing marketed tests.

Clinical Evidence

Multi-center clinical study conducted using urine samples from women presenting for pregnancy testing. Consumer study performed to validate that lay users could read package inserts, perform the test at home, and obtain results comparable to clinic personnel. Bench testing confirmed intra- and inter-assay precision, lot-to-lot consistency, and lack of interference from common drugs, chemicals, and biologicals.

Technological Characteristics

Sandwich-format lateral-flow immunoassay. Employs monoclonal and polyclonal antibodies. Visual readout via colorimetric indicators (pink/blue plus/minus signs). Standalone, single-use test device.

Indications for Use

Indicated for qualitative detection of hCG in urine as an aid in early pregnancy detection for over-the-counter home use.

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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JAN 26 1998

K974821

#### SUMMARY OF SAFETY AND EFFECTIVENESS XI.

#### Product

Bluetest® Pregnancy Test; or RapidVue® Pregnancy Test

## Manufacturer

OUIDEL Corporation 10165 McKellar Court San Diego, CA 92121 U.S.A.

#### Device Classification

Device, Bluetest Pregnancy Test, also sold under the brandname Rapid Vue Pregnancy Test, is similar to other FDA-cleared devices used for the qualitative detection of human chorionic gonadotropin (hCG). The test is used in the early detection of pregnancy and is intended to measure hCG, a abea in all comone, in urine (21 CFR 862.1155). The FDA has proposed that hCG test systems be classified as Class II.

#### Intended Use

The test is a rapid immunoassay for the qualitative detection of hCG in urine as an aid in the early detection of pregnancy. The test is intended for overthe counter home use.

#### Physiologic Basis for the Assay

Human chorionic gonadotropin (hCG) is a glycoprotein hormone secreted by the trophoblastic cells of the developing placenta as early as 7 to 8 days after ovulation. This hormone stimulates the production of progesterone and estradiol which are required to sustain pregnancy. In normal pregnancy, serum levels of hCG continue to rise during the first trimester to levels as high as 100,000 mIU/mL. Serum hCG is rapidly cleared in the urine and the concentration of hCG in serum is approximately equal to the concentration in urine. HCG is an excellent indicator of pregnancy early in the gestational period.

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## Principle of the Test

The test, a sandwich-format, lateral-flow immunoassay, employs monoclonal and polyclonal antibodies. If the sample contains hCG, a pink and blue plus sign (+) is visible in the large Result Window, along with a blue line in the small Control Window to indicate a positive result. If hCG is not present in the sample, a blue minus sign (-) is visible in the large Result Window, along with a blue line in the small Control Window, to indicate a negative result.

# Safety and Effectiveness

Numerous studies were undertaken to document the performance characteristics and the substantial equivalence of the test to other commercially available products for the qualitative detection of hCG. These studies included the following:

- · The test was shown to be similar to other commercially distributed tests in terms of features and intended use.
- · The test was shown to have excellent intra- and inter-assay precision.
- · Lot-to-lot consistency analyses showed the test to be reproducibly manufacturable.
- · Common drugs, chemicals, and biologicals were shown not to interfere with the test's performance.
- · Using urine samples obtained from women presenting for pregnancy testing, a direct comparison of the test was conducted in a multi-center clinical study.
- · A consumer study was conducted in order to show that lay users could read the package insert, perform the test in their home and obtain results similar to results obtained by clinic personnel.

## Conclusion

These studies demonstrated the substantial equivalence of the test to existing products already marketed. They further demonstrated the suitability of the product for over-the-counter home use. Such studies are a critical element in establishing the fundamental safety and effectiveness of the product and its appropriateness for commercial distribution.

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Image /page/2/Picture/1 description: The image shows the logo for Health & Human Services, USA. The logo is a circular emblem with the words "HEALTH & HUMAN SERVICES, USA" arranged in an arc at the top. Below the text is a stylized image of an eagle with its wings spread, and the number 136 is at the bottom.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 26 1998

. Robin Weiner Vice President, Clinical Develop. & Reg. Affairs QUIDEL Corporation 10165 McKellar Court San Diego, California 92121

K974821 Re : Bluetest® Pregnancy Test; or RapidVue® Pregnancy Test Regulatory Class: II Product Code: LCX Dated: December 22, 1997 December 23, 1997 Received:

Dear Ms. Weiner:

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 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 The general controls provisions of the Act 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 Requlations, 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 General regulation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements action. 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 (CDIA-66), Child device if it does, you should contact Cacegorization: - 10 asse 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 described in your sit (x, privalence 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 requlation (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/dsmamain.html".

sincerely yours,
Steven Litman

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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510(k) Number (if known): J

Bluetest® Pregnancy Test; or Bluetes. Pregnancy Test

Device Name:

Indications for Use:

The Bluetest® Pregnancy Test, also sold under the brandname The Bluetest® Pregnancy Test, is a one-step immunossay intended for RapidVue® Pregnancy Test, is a one-step immunessay detection of
the qualitative detection of hCG in urine. for the early detection of
the qualitative the intended for overshe the qualitative detection of hCG in urine for the vely and

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <div><span style="text-decoration: overline;">Kmoor for Montgomery</span></div> <div>(Division Sign-Off)</div> |
|---------------|----------------------------------------------------------------------------------------------------------------|
| Division: | Clinical Laboratory Devices |
| 510(k) Number | <span style="text-decoration: underline;">974821</span> |

| Prescription Use | |
|----------------------|--|
| (Per 21 CFR 801.109) | |

OR

| Over-The Counter Use | ✓ |
|----------------------|---|
|----------------------|---|

Pr (Per 21 CFR 801.109)

(Optional Format 1-2-96)

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