ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG-005

K032987 · Unotech Diagnostics, Inc. · JHI · Nov 17, 2003 · Clinical Chemistry

Device Facts

• Record ID: K032987
• Device Name: ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG-005
• Applicant: Unotech Diagnostics, Inc.
• Product Code: JHI · Clinical Chemistry
• Decision Date: Nov 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The intended use of the Unotech Accutest and Accustrip hCG-Combo is for the qualitative determination of human chorionic gonadotropin (hCG) in human urine or serum for the early detection of pregnancy.

Device Story

Immunochromatographic test for qualitative hCG detection in urine or serum; utilizes mouse anti-beta hCG monoclonal antibody-colloidal gold conjugate. Sample application via dipstick (AccuStrip) or cassette sample well (AccuTest). HCG-antibody-gold complex migrates to immobilized goat anti-alpha hCG capture region and goat anti-mouse IgG control region. Positive result indicated by two colored bands at 25 mIU/mL hCG; negative result indicated by single control band. Used in clinical settings; operated by healthcare professionals. Provides rapid visual confirmation of pregnancy status to aid clinical decision-making.

Clinical Evidence

Comparative study of 181 specimens (94 urine, 87 serum) from patients seeking pregnancy confirmation. Subject devices compared against Quidel QuickVue hCG Combo Test. Results showed 100% agreement. Sensitivity verified using spiked samples at 0, 25, 50, 104, 5x10^5, and 10^6 mIU/mL; 100% detection at 25 mIU/mL and above.

Technological Characteristics

Lateral flow immunoassay test system. Qualitative detection of hCG. Compatible with human urine or serum. Sensitivity range: 25 mIU/mL to 1,000,000 mIU/mL.

Indications for Use

Indicated for the qualitative determination of hCG in human urine or serum for the early detection of pregnancy in patients seeking confirmation of pregnancy.

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

• Quidel QuickVue hCG Combo Test

Submission Summary (Full Text)

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NOV 17 2003

032987

510(k) Notification Unotech Diagnostics Inc. AccuTest™ hCG-Combo AccuStrip™hCG-Combo September 22, 2003

## 510(k) Summary of Safety and Substantial Equivalence Discussio

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

We conducted a comparison study with Unotech's AccuTest™ hCG-Combo, AccuStrip™ hCG-Combo and Quidel's QuickVue hCG Combo Test. A total of 181 specimens (94 urine specimens and 87 serum specimens) from patients seeking confirmation of pregnancy were tested simultaneously with AccuTest™ hCG-Combo, AccuStrip™ hCG-Combo and QuickVue hCG Combo tests. Test results show that both Unotech's AccuTest™ hCG-Combo and AccuStrin™ hCG-Combo have 100% agreement with the QuickVue hCG Combo Test. Table 1A shows the test results of comparison study with urine specimens. Table 1B shows the test results of comparison study with serum specimens.

Comparison of AccuTest™ hCG-Combo and AccuStrip™ hCG-Combo with the Table 1A: Quidel QuickVue hCG Combo Test Using Urine Specimens

| | Unotech<br>AccuTest™ hCG-Combo | Unotech<br>AccuStrip™ hCG-Combo | Quidel<br>QuickVue hCG Combo |
|----------|--------------------------------|---------------------------------|------------------------------|
| Positive | 48 | 48 | 48 |
| Negative | 46 | 46 | 46 |

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## Comparison of AccuTest™ hCG-Combo and AccuStrip™ hCG-Combo with the Table 1B: Ouidel OuickVue hCG Combo Test Using Serum Specimens

| | Unotech<br>AccuTest™ hCG-Combo | Unotech<br>AccuStrip™ hCG-Combo | Quidel<br>QuickVue hCG Combo |
|----------|--------------------------------|---------------------------------|------------------------------|
| Positive | 42 | 42 | 42 |
| Negative | 45 | 45 | 45 |

The following experiments were carried out to evaluate the sensitivity of AccuTest™ hCG-Combo, and AccuStrip™ hCG-Combo at low end and high end levels of hCG. Pooled negative urine and serum specimens were spiked with hCG to the concentrations of 0, 25, 50, 104, 5×10° and 10° mIU/mL and tested with AccuTest™ hCG-Combo and AccuStrip™ hCG-Combo. A total of 60 urine samples and 60 serum samples were blind labeled and tested with the AccuTest™ hCC-Combo and AccuStrip™ hCG-Combo. Test results obtained from these experiments are the same using AccuTest™ hCG-Combo or AccuStrip™ hCG-Combo Tests with serum or urine specimens. The results are presented in Table 2.

| Table 2: | Sensitivity Test Results |
|----------|--------------------------|
|----------|--------------------------|

| hCG (mIU/mL) | 0 | 25 | 50 | $10^4$ | $5\times10^5$ | $10^6$ |
|--------------|----|----|----|--------|---------------|--------|
| # of samples | 10 | 10 | 10 | 10 | 10 | 10 |
| Positive | 0 | 10 | 10 | 10 | 10 | 10 |
| Negative | 10 | 0 | 0 | 0 | 0 | 0 |

The results demonstrate that the Unotech AccuTest™ hCG-Combo and AccuStrip™ hCG-Combo can detect hCG in urine or serum 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-Combo and AccuStrip™ hCG-Combo are substantially equivalent to the Quidel QuickVue hCG Combo Test.

The intended use of the Unotech AccuTest™ hCG-Combo and AccuStrip™ hCG-Como is for the early detection of pregnancy by the qualitative determination of human chorionic gonadotropin (hCG) in human urine or serum. Our intent is to market these products to clinical laboratories in the U.S.A. as well as in the foreign countries.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a wavy line representing the body.

NOV 17 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

k032987 Re:

Trade/Device Name: Unotech Accutest™ hCG-Combo and Accustrip™ hCG-Combo Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (hCG) test system Regulatory Class: Class II Product Code: JHI Dated: September 22, 2003 Received: September 26, 2003

Dear Dr. Wu:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 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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Page 2 –

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Recod 10-27-03

Page 1 of 2

510(k) Number (if know): N/A_

Device Name: Accutest hCG-Combo

Indications For Use:

The intended use of the Unotech Accutest hCG-Combo is for the qualitative determination of human chorionic gonadotropin (hCG) in human urine or serum for the early detection of pregnancy.

Carol Benson for Jean Cooper, DVM
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K032987

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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Recyd 10-21-03

Page 2_of_2

510(k) Number (if know): N/A

Device Name: Accustrip hCG-Combo

Indications For Use:

The intended use of the Unotech Accustrip hCG-Combo is for the qualitative determination of human chorionic gonadotropin (hCG) in human urine or serum for the early detection of pregnancy.

Carol C. Benson & Jean Cooper, OVM
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K032987

## PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGES IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use J (Per 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)