QUICKVUE ONE-STEP HCG-COMBO

K973841 · Quidel Corp. · JHI · Dec 1, 1997 · Clinical Chemistry

Device Facts

• Record ID: K973841
• Device Name: QUICKVUE ONE-STEP HCG-COMBO
• Applicant: Quidel Corp.
• Product Code: JHI · Clinical Chemistry
• Decision Date: Dec 1, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The QuickVue® One-Step hCG-Combo is a one-step immunoassay intended for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early detection of pregnancy. The QuickVue One-Step hCG-Combo is intended for use by health care professionals.

Device Story

QuickVue One-Step hCG-Combo is a rapid lateral flow immunoassay for qualitative hCG detection in serum or urine. Sample is added to a test cassette; hCG presence triggers a pink-to-purple test line; a blue procedural control line confirms test validity. Used in physician office laboratories and clinical settings by healthcare professionals. Provides immediate visual results to confirm pregnancy status, aiding clinical decision-making regarding patient care. Benefits include rapid, accurate, and reproducible pregnancy testing.

Clinical Evidence

Bench testing and clinical comparison studies performed. Accuracy >99% demonstrated via direct comparison to Hybritech ICON II HCG ImmunoConcentration Assay. Physician's Office Laboratory studies at three distinct U.S. sites showed 100% agreement with expected results across diverse personnel. Precision (intra- and inter-assay) and lot-to-lot consistency confirmed. No interference from common drugs, chemicals, or biologicals.

Technological Characteristics

Lateral flow immunoassay cassette. Qualitative visual readout. Detects hCG glycoprotein hormone. No electronic components, software, or external energy source required. Manual performance.

Indications for Use

Indicated for the qualitative detection of hCG in serum or urine for early pregnancy detection in patients. Intended for use 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.

Reference Devices

• Hybritech® ICON® II HCG ImmunoConcentration™ Assay

Submission Summary (Full Text)

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15-112341

#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS XI.

DEC - 1 1997

#### Product:

OuickVue® One-Step hCG-Combo

### Manufacturer:

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

#### Device Classification:

The device, QuickVue One-Step hCG-Urine, is similar to other FDA-cleared devices used for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine. The test is used in the early detection of pregnancy and is intended to measure hCG, a placental hormone, in serum, plasma or 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 serum or urine. This test is to be used for the early detection of pregnancy.

#### 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:

Serum or urine is added to the Sample Well on the Test Cassette. Shortly after addition of the sample, a blue procedural Control Line will appear in the Result Window. If hCG is present in the sample, a pink-to-purple Test Line will also appear. If hCG is not present, only the blue procedural Control Line. will appear.

## 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 in serum or urine. These studies included the following:

- · The test was shown to be similar to other commercially distributed in vitro 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 samples obtained from women presenting for pregnancy testing, a direct comparison of the test to the Hybritech® ICON® II HCG ImmunoConcentration™ Assay for qualitative hCG detection was conducted. An accuracy exceeding 99% was observed.
- · Physician's Office Laboratory studies were conducted to show that doctor's office personnel with diverse educational backgrounds and work experience could perform the test accurately and reproducibly. Testing was performed at three geographically distinct sites in the United States. The results obtained at each site agreed 100% with the expected results.

## Conclusion:

These studies demonstrated the substantial equivalence of the QuickVue One-Step hCG-Combo to existing products already marketed. They further demonstrated the suitability of the product for use by health care professionals. 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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC - 1 1997

Robin Weiner . Vice President, Clinical Develop. & Reg. Affairs OUIDEL Corporation 10165 Mc Kellar Court San Diego, California 92121

Re : K973841 QuickVue® One-Step hCG-Combo Requlatory Class: II Product Code: JHI October 7, 1997 Dated: Received: October 8, 1997

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, Druq, 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 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 requlations.

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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 findinq 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/dsmamain.html".

sincerely yours,
Steven Butman

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 _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): K973841

Device Name:

QuickVue® One-Step hCG-Combo

Indications for Use:

The QuickVue® One-Step hCG-Combo is a one-step immunoassay intended for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early detection of pregnancy. The QuickVue One-Step hCG-Combo is intended for use by health care professionals.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Clinical Laboratory vice

| 510(k) Number | 973841 |
|---------------|--------|
|---------------|--------|

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

(Optional Format 1-2-96)