PREG-Q EARLY PREGNANCY TEST

K023027 · Yd Diagnostics · LCX · Dec 16, 2002 · Clinical Chemistry

Device Facts

• Record ID: K023027
• Device Name: PREG-Q EARLY PREGNANCY TEST
• Applicant: Yd Diagnostics
• Product Code: LCX · Clinical Chemistry
• Decision Date: Dec 16, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The Preg-Q early pregnancy test is a rapid visual test for the qualitative detection of hCG in urine to aid in the determination of pregnancy. This test is for over-the counter, central laboratory, and point of care hospital use.

Device Story

Preg-Q Early Pregnancy Test is a rapid visual diagnostic device for qualitative detection of hCG in urine. Device utilizes lateral flow immunoassay technology to detect pregnancy-related hormones. Used in OTC, central laboratory, and point-of-care hospital settings. User applies urine sample to test device; results appear visually within 5 minutes. Healthcare providers or patients interpret presence or absence of test lines to determine pregnancy status. Provides rapid clinical information to aid in pregnancy diagnosis.

Clinical Evidence

Bench testing only. Performance evaluated through comparison of interference, accuracy, sensitivity, and specificity against the predicate device. No clinical trial data provided.

Technological Characteristics

Rapid visual lateral flow immunoassay. Qualitative detection of hCG in urine. 5-minute test time. Standalone test device.

Indications for Use

Indicated for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the determination of pregnancy. Intended for use by individuals in over-the-counter settings, as well as by professionals in central laboratories and point-of-care hospital environments.

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

• Testpack Plus HCG Urine (K954029)

Submission Summary (Full Text)

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K023027

# 510(k) SUMMARY (as required by 807.92(c))

DEC 1 6 2002

Submitter of 510(k): YD Diagnostics 228-8Chamsil-Dong,Songapa-Gu Keuk-Dong A,Bldg.2F Seoul, 138-220, Korea

Contact Person: Contact Phone Number: Mr. J.M. Lee 82-2-2233-5687 1-800-365-6146

Date of Summary: June 1,2002

| Trade Name: | Preg-Q Early Pregnancy Test |
|----------------------|-----------------------------------------------|
| Classification Name: | Radioimmunoassay,Human Chorionic Gonadotropin |
| Predicate Device: | Testpack Plus HCG Urine K954029 |

The Preg-Q early pregnancy test is a rapid visual test for Intended Use: the qualitative detection of hCG in urine to aid in the determination of pregnancy. This test is for over-the counter, central laboratory, and point of care hospital use..

### Device Comparison:

| | Preg-Q Early<br>Pregnancy Test | Testpack Plus HCG<br>Urine |
|-------------------|--------------------------------|----------------------------|
| 510(k) | | K954029 |
| Testing Completed | Interference | Same |
| | Accuracy | Same |
| | Sensitivity | Same |
| | Specificity | Same |
| | Reading Time | Same |
| | OTC Comparison | N/A |
| Intended Use | Detection of hCG | Same |
| Intended Specimen | Urine | Same |
| Results | Qualitative | Qualitative |
| Test Time | 5 minutes | 5 minutes |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

YD Diagnostics c/o Mr. Arthur J. Ward RMS Regulatory and Marketing Services, Inc. 962 Allegro Lane Apollo Beach, FL 33572

DEC 1 6 2002

k023027 Re:

> Trade/Device Name: Preg-Q Early Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (HCG) Test System Regulatory Class: Class II Product Code: LCX, JHI Dated: October 28, 2002 Received: October 29, 2002

Dear Mr. Ward:

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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This letter will allow you to begin marketing your device as described in your Section 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 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). Other general information on your responsibilities under the Act may be obtained 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 Sutman

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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510(k) Number (if knov

Preg-Q Early Pregnancy Test Device Name:

#### Indications For Use:

The Preg-Q hCG Early Pregnancy Test is a rapid visual test for the qualitative detection of hCG in urine to aid in the determination of pregnancy. This test is for over- the-counter, central laboratory, and point of care hospital use.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jean Crozer
(Division Sign-Off)

Division of Clinical Laboratory Devices
510(k) Number K023027

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)