ACCUTEST HCG-URINE

K971886 · Unotech Diagnostics, Inc. · JHI · Jun 11, 1997 · Clinical Chemistry

Device Facts

• Record ID: K971886
• Device Name: ACCUTEST HCG-URINE
• Applicant: Unotech Diagnostics, Inc.
• Product Code: JHI · Clinical Chemistry
• Decision Date: Jun 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The intended use of the Unotech AccuTest hCG-Urine is for the qualitative determination of human chorionic gonadotropin (hCG) in human urine for the early detection of pregnancy. We intend to market this product to physicians' offices laboratories and clinical laboratories in the U.S.A. as well as in the foreign countries.

Device Story

AccuTest™ hCG-Urine is an in vitro diagnostic test for qualitative detection of hCG in human urine; used in physician office laboratories and clinical laboratories. Device utilizes immunochemical principles to detect hCG concentrations; provides visual qualitative results. Healthcare providers use results to confirm pregnancy status. Benefits include rapid, early pregnancy detection.

Clinical Evidence

Multicenter clinical study conducted in three physician office laboratories. Total of 197 urine specimens tested using both AccuTest™ hCG-Urine and Abbott TestPack Plus™ hCG-COMBO. Study population included female patients seeking pregnancy confirmation, confirmed pregnant patients, and 8 post-menopausal women. Results demonstrated 100% agreement between the subject and predicate devices. Analytical sensitivity testing confirmed detection at levels from 25 mIU/mL to 1,000,000 mIU/mL.

Technological Characteristics

Immunochemical lateral flow or similar immunoassay format for qualitative hCG detection. Designed for professional use in clinical laboratory settings. No electronic components, software, or external energy sources required.

Indications for Use

Indicated for the qualitative detection of human chorionic gonadotropin (hCG) in human urine to aid in the early detection of pregnancy in female patients.

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™ hCG-COMBO

Submission Summary (Full Text)

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K971886

510(k) Notification Unotech Diagnostics Inc. AccuTest™ hCG-Urine May 21, 1997

## 510(k) Summary of Safety and Effectiveness Substantial Equivalence Discussion

| Trade or Proprietary Name: | AccuTest™ hCG-Urine |
|-----------------------------|---------------------------------------------------------------------------------------|
| Common or Usual Name: | Human Chorionic Gonadotropin Test System |
| Product Classification No.: | 21 CFR §862.1155, Class II |
| Manufacturer: | Unotech Diagnostics Inc.<br>2235 Polvorosa Avenue, Suite 220<br>San Leandro, CA 94577 |
| Contact Person: | Ken Wu, Ph.D.<br>President<br>Phone: [phone] |

We conducted a multicenter clinical study in three physicians' offices laboratories. We provided each site with the Unotech AccuTest™ hCG-Urine and the Abbott TestPack Plus™ hCG-COMBO.

A total of 197 urine specimens were tested in these physicians' offices laboratories using both Unotech and Abbott tests. Clinical subjects included female patients seeking confirmation of pregnancy, those who were confirmed pregnant, and 8 post-menopausal women.

The test results show that the Unotech AccuTest™ hCG-Urine has 100% agreement with the Abbot TestPack Plus™ hCG-COMBO.

| | Unotech<br>AccuTest™ hCG-Urine | Abbott<br>TestPack Plus™ hCG-COMBO |
|----------|--------------------------------|------------------------------------|
| Positive | 70 | 70 |
| Negative | 127 | 127 |

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The following experiments were carried out to evaluate the sensitivity of AccuTest™ hCG-Urine at low end and high end levels of hCG. Urine samples with hCG concentrations of 0, 25, 50, 10', 10', 104, 105, 5x105 and 106 mIU/mL were tested. The results are presented below. 27

| hCG (mIU/mL) | 0 | ટેટ | રે રેણે રહ્યા છે. આ ગામનાં પ્રાથમિક શાળા, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ | | | 102 | | 5x105 106 1 | | 1 min |
|--------------|----|-----|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|-----|----|-------------|----|-------|
| # of samples | 10 | 10 | 10 - | 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - | 10 | 10 | 10 | 10 | 10 | |
| Positive | 0 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | |
| Negative | 10 | 0 | | 0 0 0 0 0 0 0 | | 0 0 | | 0 | 0 | |

The results demonstrate that the Unotech AccuTest™ hCG-Urine Test can detect hCG in urine at levels as low as 25 mIU/mL and as high as 1,000,000 mIU/mL.

These results establish that the Unotech AccuTest™ hCG-Urine Test is substantially equivalent to the Abbott Test Pack Plus™ hCG-COMBO Test.

The intended use of the Unotech AccuTest™ hCG-Urine is for the early detection of pregnancy by the qualitative determination of human chorionic gonadotropin (hCG) in human urine. Our intent is to market this product to physicians' offices laboratories and clinical laboratories in the U.S.A. as well as in the foreign countries.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN | | 1997

Ken Wu, Ph.D. President Unotech Diagnostics Inc. . 2235 Polvorosa Avenue, Suite 220 San Leandro, California 94577

Re : K971886 Unotech AccuTest™ hCG-Urine Requlatory Class: II Product Code: JHI Dated: May 21, 1997 May 22, 1997 Received:

Dear Dr. Wu:

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 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 Requlations, Title 21, Parts 800 to 895. ਸੈਂ substantially equivalent determination assumes compliance with the Good Manufacturing Fractice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 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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Page 1_ of 1_

(k) Number (if known): ___K971886

ice Name:___AccuTest hCG-Urine_

cations For Use: _

me intended use of the Unotech AccuTest hCG-Urine is for the qualitative determination of human chorionic gonadotropin (hCG) in human urine for the early detection of pregnancy. We intend to market this product to physicians' offices laboratories and clinical laboratories in the U.S.A. as well as in the foreign countries.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) |
|-----------------------------------------|
| Division of Clinical Laboratory Devices |

510(k) Number***_***_

OR

Prescription Use_V Per 21 CFR 801.109)

Ove

Over-The-Counter Use_

(Optional Format 1-2-96)