AZOG, INC. HCG ONE-STEP URINE HOME PREGNANCY TEST (DIP STICK, CASSETTE AND MIDSTREAM)

K041748 · Azog, Inc. · LCX · Aug 9, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041748
• Device Name: AZOG, INC. HCG ONE-STEP URINE HOME PREGNANCY TEST (DIP STICK, CASSETTE AND MIDSTREAM)
• Applicant: Azog, Inc.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Aug 9, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The AZOG hCG One-Step (Urine) Pregnancy Home Test (DipStick, Cassette and Midstream) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy at home.

Device Story

Rapid chromatographic immunoassay for qualitative hCG detection in urine; utilizes monoclonal antibodies to detect elevated hCG levels. User applies urine to sample well; specimen migrates via capillary action along membrane. Positive result indicated by colored line at test region; control line confirms proper test performance. Used at home by lay users. Provides visual qualitative output to aid pregnancy detection.

Clinical Evidence

Usability study of 100 female subjects (age 18+) compared lay-user results to professional testing. 100% agreement for DipStick and Cassette formats. Midstream format showed 92.31% accuracy compared to predicate (2 false positives, 1 false negative, 1 invalid). Method comparison of 60 clinical urine specimens between midstream and cassette formats showed 100% agreement.

Technological Characteristics

Rapid chromatographic immunoassay; utilizes monoclonal hCG antibodies. Form factors include dipstick, cassette, and midstream. Standardized to W.H.O. Third International Standard. No electronic components or software.

Indications for Use

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

Predicate Devices

• k022680
• k022681

Submission Summary (Full Text)

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K041748

AUG - 9 2004

#### 510(k) SUMMARY

# DEVICE NAME: AZOG,Inc. One-Step Urine Pregnancy Home Test (DipStick, Cassette and Midstream).

| APPLICANT NAME: | AZOG, Inc.<br>1011 US HWY 22 WEST<br>PHILLIPSBURG, NJ 08865 |
|-----------------|---------------------------------------------------------------|
| CONTACT: | AZUBUIKE OGALA<br>Tel.: [phone]<br>Fax: [phone] |

#### INTENDED USE:

The AZOG hCG One-Step (Urine) Pregnancy Home Test (DipStick, Cassette and Midstream) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy at home.

# DESCRIPTION OF THE DEVICE

The AZOG hCG One-Step Urine Pregnancy Home Test (Urine) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test utilizes a combination of antibodies including a monoclonal hCG antibody to selectively detect elevated levels of hCG. The assay is conducted by adding urine into the sample well of the device and observing the formation of colored lines. The specimen migrates via capillary action along the membrane to react with the colored conjugate.

Positive specimens react with the specific antibody-hCG-colored conjugate to form a colored line at the test line region of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line will always appear at the control line region if the test has been performed properly.

111

AZOG, Inc. hCG One-Step Urine Home Pregnancy Test [DipStick, Device (Cassette) and Midstream]

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# SAFETY AND EFFECTIVENESS DATA:

## Assay Precision/Tolerance (k022680 and k022681)

An evaluation of AZOG, Inc. hCG One-Step Urine Pregnancy Test (DipStick, Cassette and Midstream) was conducted using a panel of 3 coded specimens. The proficiency panel contained negative, low positive and high positive specimens. Two different operators tested each level in replicates of five over a period of three days.

No differences were observed within run (5 replicates), between runs (three different assay days), or between operators (two operators).

### Correlation (k022680. k022681 and current submission)

A total of 310 urine specimens were tested using the AZOG, Inc. hCG One-StepUrine Pregnancy Test (DipStick, Cassette and Midstream). When these results were compared to results obtained from a similar device, the result demonstrated overall agreement of greater than or equal to 99% of the AZOG, Inc. hCG One-Step Urine Pregnancy Home Test (DipStick, Cassette and Midstream).

# Sensitivity and Specificity (k022680 and k022681)

The AZOG, Inc. hCG One-Step Urine Pregnancy Test (DipStick, Cassette and Midstream) detects hCG at 25 mIU/mL or greater. The test has been standardized to the W.H.O. Third International Standard. The addition of LH (1000 mIU/mL), FSH (1000 mIU/mL) and TSH (1000 µIU/mL) to negative (0 mIU/mL hCG) and positive (25 mIU/mL hCG) specimens showed no crossreactivity.

#### Interference Study (k022680 and k022681)

None of the potentially interfering substances tested interfered in the AZOG, Inc. hCG One-Step Urine Pregnancy Test (DipStick, Cassette and Midstream) assay.

AZOG, Inc. hCG One-Step Urine Home Pregnancy Test [DipStick, Device (Cassette) and Midstream]

112

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG - 9 2004

Mr. Azubuike Ogala President/V.P., Research & Development Azog, Inc. 1011 US Hwy 22 West Phillipsburg, NJ 08865

k041748 Re:

K0+17+6
Trade/Device Name: AZOG, Inc. hCG One-Step Urine Home Pregnancy Test (Dipstick, Cassette and Midstream)

Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: June 18, 2004 Received: June 29, 2004

Dear Mr.Ogala:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated)76, the enactment date of the Medical Device Amendments, or to conninered provide in accordance with the provisions of the Federal Food, Drug, de rices that have boon require approval of a premarket approval application (PMA). and Cosmetic Act (11ct) that Lo novice, subject to the general controls provisions of the Act. The r ou may, mercrore, mains of the Act include requirements for annual registration, listing of general controls profitering 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 n may of bund 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 or any I sactar band 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

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you'to ought heating of substantial equivalence of your device to a legally premarket notification: "The PDF intembers on the sour device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, If you destic specific mixed advertising of your device, please contact the Office of or questions on the promise Evaluation and Safety at [phone]. Also, please note the In I the Diagnostic Do reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou inay ovain other general see 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,

Jean M. Cooper, US, DVM.

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): k041748

Device Name: AZOG, Inc. hCG One-Step Urine Home Pregnancy Test (Dipstick, Cassette and Midstream)

Indications For Use: AZOG, Inc. hCG One-Step Urine Home Pregnancy Test (DipStick, Cassette and Indications FOF OSE. AZOG, file: not one enp this if Human Chrisnic Gonadotropin (hCG) in
Midstream) are intended for the qualitative determinel Une The for the for the early Midstream) are intended for the Qualiative determination of Human United The Test is for the early detection of pregnancy.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

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

11.201 Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k) K0411748