K Number
K973570
Device Name
QUICK CARD HCG ONE STEP PREGNANCY TEST
Manufacturer
Date Cleared
1997-10-31

(42 days)

Product Code
Regulation Number
862.1155
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
An hCG pregnancy test intended for over the counter use by lay persons is an in vitro diagnostic test for the qualitative identification of human Chorionic Gonadotropin (hCG), a human hormone, in urine. Measurements that are obtained by this device are used in the diagnosis of pregnancy.
Device Description
Immunoassay for the Qualitative Detection of Human Chorionic Gonadotropin (hCG) in Urine for the Detection of Early Pregnancy. The QuickCard HCG One Step Pregnancy Test, like many commercially available pregnancy test kits, qualitatively measures the presence of HCG by visual color sandwich one step immunoassay technology.
More Information

Unipath Clearview HCG, Abbot Laboratories' Fact Plus, Syntron Bioresearch Be Sure Pregnancy Test

Quidel RapidVue, Syntron Bioresearch Be Sure Pregnancy Test

No
The device description and performance studies indicate a standard immunoassay technology with visual interpretation, with no mention of AI or ML.

No.
The device is used to diagnose pregnancy, not to treat any condition or disease.

Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an in vitro diagnostic test for the qualitative identification of human Chorionic Gonadotropin (hCG)... Measurements that are obtained by this device are used in the diagnosis of pregnancy."

No

The device description clearly indicates it is an immunoassay using visual color sandwich one step technology, which is a physical test kit, not software.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use explicitly states it's "an in vitro diagnostic test for the qualitative identification of human Chorionic Gonadotropin (hCG)... in urine." It also states that the measurements are "used in the diagnosis of pregnancy." This directly aligns with the definition of an IVD, which is a medical device used to examine specimens derived from the human body to provide information for diagnostic purposes.
  • Device Description: The description confirms it's an "Immunoassay for the Qualitative Detection of Human Chorionic Gonadotropin (hCG) in Urine." Immunoassays performed on bodily fluids are a common type of IVD.
  • Specimen Type: The device analyzes urine, which is a specimen derived from the human body.

The information provided clearly indicates that this device is designed to perform a test on a human specimen (urine) outside of the body (in vitro) to aid in the diagnosis of a medical condition (pregnancy).

N/A

Intended Use / Indications for Use

The QuickCard HCG One Step Pregnancy Test is intended to detect the presence of Human Chorionic Gonadotropin (hCG) in Urine for the women who suspect they may be pregnant. HCG is a well know and established analyte used to confirm pregnancy because of its early appearance in urine following conception followed by a dramatic increase in concentration.

An hCG pregnancy test intended for over the counter use by lay persons is an in vitro diagnostic test for the qualitative identification of human Chorionic Gonadotropin (hCG), a human hormone, in urine. Measurements that are obtained by this device are used in the diagnosis of pregnancy.

Product codes (comma separated list FDA assigned to the subject device)

LCX

Device Description

Immunoassay for the Qualitative Detection of Human Chorionic Gonadotropin (hCG) in Urine for the Detection of Early Pregnancy

The QuickCard HCG One Step Pregnancy Test, like many commercially available pregnancy test kits, qualitatively measures the presence of HCG by visual color sandwich one step immunoassay technology.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Home use by lay persons (over the counter use).

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

A study was conducted at five geographically distinct locations using a panel of coded specimens to demonstrate that lay people, not clinical professionals, could perform the QuickCard HCG One Step Pregnancy Test reproducibly and obtain accurate results. The proficiency panel contained negative (0 mIU/mL) and low positive (40 mIU/mL) hCG urine specimens.

Individuals were instructed to follow the QuickCard HCG One Step Pregnancy Test package insert to perform and read the assay. In no case was there any verbal communication between the trial participant and Phamatech with regard to assay procedure or interpretation. Trial participants were supplied with coded specimens and QuickCard HCG One Step Pregnancy Tests. Most participants received a set containing 1 coded positive sample and 1 coded negative sample. One participant received 2 coded negative samples.

Study Population: Trial participants ranged in age from 16 to 55 years of age. Respondents were of diverse occupational backgrounds, from students and housewives to accountants, chemists and pharmacists. Approximately 25% of the respondents were of Asian decent (sic), 10% were Hispanic, while the remainder were African American and Caucasian.

Study Design: Coded urine samples were prepared as follows: Samples 1 and 3 were normal pooled male urine samples spiked to 40 mIU/mL hCG (WHO 1st IRP). Samples 2 and 4 were 0 mlU/mL hCG. Trial participants each were sent two (2) QuickCard HCG One Step Pregnancy Tests, two (2) coded samples, 1 pair of latex gloves and general instructions. Included in each "kit" was a survey explanation, a questionnaire and a self-addressed, stamped envelope.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The product performance characteristics of the QuickCard HCG One Step Pregnancy Test were evaluated in a clinical sample correlation study and a blind labeled spiked HCG study.

Correlation studies, using clinical specimens, produced a >99% correlation when compared to the Quidel RapidVue and the Syntron Bioresearch Be Sure Pregnancy Test.

A blind labeled spiked consumer study was performed; the Phamatech QuickCard exhibited excellent sensitivity (122/123), specificity (122/123), and accuracy (244/246) in the hands of lay users.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Sensitivity (122/123), specificity (122/123), and accuracy (244/246)

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Unipath Clearview HCG, Abbot Laboratories' Fact Plus, Syntron Bioresearch Be Sure Pregnancy Test

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Quidel RapidVue, Syntron Bioresearch Be Sure Pregnancy Test

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 862.1155 Human chorionic gonadotropin (HCG) test system.

(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)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.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. 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.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.

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Fax:6196355843

0:06 P. 04
K973570

OCT 3 1 1997

510(k) SUMMARY AS REQUIRED BY SECTION 807.92(C)

Identification: QuickCard HCG One Step Pregnancy Test (9011)

Description: Immunoassay for the Qualitative Detection of Human Chorionic Gonadotropin (hCG) in Urine for the Detection of Early Pregnancy

Name of Manufacturer: Phamatech 9265 Activity Road #112 San Diego, California, 92126, USA

Intended Use: The QuickCard HCG One Step Pregnancy Test is intended to detect the presence of Human Chorionic Gonadotropin (hCG) in Urine for the women who suspect they may be pregnant. HCG is a well know and established analyte used to confirm pregnancy because of its early appearance in urine following conception followed by a dramatic increase in concentration.

Technology: The QuickCard HCG One Step Pregnancy Test, like many commercially available pregnancy test kits, qualitatively measures the presence of HCG by visual color sandwich one step immunoassay technology. Examples of such predicate devices include the Unipath Clearview HCG (Mountainview, CA 94043), Abbot Laboratories' Fact Plus (Abbot Park, IL 60064) and the Syntron Bioresearch Be Sure Pregnancy Test (Carlsbad, CA 92008). All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / HCG / antibody complexes.

Performance: The product performance characteristics of the QuickCard HCG One Step Pregnancy Test were evaluated in a clinical sample correlation study and a blind labeled spiked HCG study. The results of these studies demonstrate the Phamatech QuickCard HCG One Step Pregnancy Test to be substantially equivalent to the reported performance characteristics of other commercially available test for the qualitative detection of early pregnancy. Correlation studies, using clinical specimens, produced a >99% correlation when compared to the Quidel RapidVue (San Diego, CA 92121) and the Syntron Bioresearch Be Sure Pregnancy Test (Carlsbad, CA 92008). A blind labeled spiked consumer study was performed; the Phamatech QuickCard exhibited excellent sensitivity (122/123), specificity (122/123), and accuracy (244/246) in the hands of lay users.

Conclusion: For the reasons mentioned above, it may be concluded that the Phamatech QuickCard HCG One Step Pregnancy Test is substantially equivalent to a variety of pregnancy tests currently in commercial distribution.

1

IV. Consumer Survey:

Introduction:

  • A study was conducted at five geographically distinct locations using a panel . of coded specimens to demonstrate that lay people, not clinical professic nals, could perform the QuickCard HCG One Step Pregnancy Test reprodicibly and obtain accurate results. The proficiency panel contained negative (0 mIU/mL) and low positive (40 mIU/mL) hCG urine specimens.
  • Individuals were instructed to follow the QuickCard HCG One Step Pregr ancy . Test package insert to perform and read the assay. In no case was them any verbal communication between the trial participant and Phamatech with regard to assay procedure or interpretation. Trial participants were sur plied with coded specimens and QuickCard HCG One Step Pregnancy Tests. Most participants received a set containing 1 coded positive sample and 1 c >ded negative sample. One participant received 2 coded negative samples.

Study Population:

  • . Trial participants ranged in age from 16 to 55 years of age. Respondents were of diverse occupational backgrounds, from students and housewivi s to accountants, chemists and pharmacists. Approximately 25% of the respondents were of Asian decent, 10% were Hispanic, while the rema nder were African American and Caucasian.

Study Design:

  • Coded urine samples were prepared as follows: .
    Samples 1 and 3 were normal pooled male urine samples spiked o 40 mIU/mL hCG (WHO 1st IRP).

Samples 2 and 4 were 0 mlU/mL hCG.

  • . Trial participants each were sent two (2) QuickCard HCG One Step Pregnancy Tests, two (2) coded samples, 1 pair of latex gloves and ge neral instructions (see page 39). Included in each "kit" was a survey explanati on, a questionnaire (see page 40) and a self-addressed, stamped envelope.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure or a bird in flight.

Public Health Service ..........................................

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 31 1997

Tuan Pham President Phamatech, Inc. 9265 Activity Road, # 112/113 San Diego, California 92126

Re : K973570 Quick Card HCG One Step Preqnancy Test Requlatory Class: II Product Code: LCX Dated: August 17, 1997 - -September 19, 1997 Received:

Dear Mr. Pham:

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 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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 (770) 488-7655.

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 leqally 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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

4

INDICATIONS FOR USE

l

Applicant: Phamatech

510(k) Number (if known):

Device Name: QuickCard HCG One Step Pregnancy Test

Indications for Use:

An &CG pregnancy test intended for over the counter use by lay persons is an in An nCG pregnancy to the qualitative identification of human Chorionic Gonadotropin (hCG), a human hormone, in urine. Measurements that are optained by this device are used in the diagnosis of pregnancy.

PLEASE DO NOT WRITE BELOW THIS LINE

Concurrence of CDRH Office of Device Evaluation (ODE)

Division Sign-Off Division of Clinical Laboratory Devices 510(k) Number:

Prescription Use: __

Over the Counter: _

Per 21 CFR 801.109

OR

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K973570