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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the QuickCard HCG One Step Pregnancy Test, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state pre-defined acceptance criteria in terms of specific thresholds for sensitivity, specificity, or accuracy. Instead, it describes performance in relation to substantial equivalence to predicate devices and "excellent" results in a lay-user study.

Performance Metric	Acceptance Criteria (Implicit/Inferred)	Reported Device Performance
Clinical Correlation Study	Substantially equivalent to predicate devices with >99% correlation.	>99% correlation when compared to Quidel RapidVue and Syntron Bioresearch Be Sure Pregnancy Test.
Lay-User Study (Sensitivity)	"Excellent sensitivity" (specific numerical threshold not given, but context of 122/123 suggests high).	122/123 (99.19%)
Lay-User Study (Specificity)	"Excellent specificity" (specific numerical threshold not given, but context of 122/123 suggests high).	122/123 (99.19%)
Lay-User Study (Accuracy)	"Excellent accuracy" (specific numerical threshold not given, but context of 244/246 suggests high).	244/246 (99.19%)

2. Sample Size Used for the Test Set and Data Provenance

A specific, single "test set" sample size for the clinical correlation study is not explicitly stated. It refers to "clinical specimens" and "correlation studies."
For the blind labeled spiked consumer study (lay-user study):
- Sample Size: Not explicitly stated as a single number of participants. The results (122/123 sensitivity, 122/123 specificity, 244/246 accuracy) suggest a total of 246 cases were evaluated (123 positive detections and 123 negative detections if perfectly balanced, or some combination leading to 246 total readings). The "Most participants received a set containing 1 coded positive sample and 1 coded negative sample. One participant received 2 coded negative samples" suggests a minimum of 123 participants, with at least one receiving two negative samples, and others receiving one positive and one negative.
- Data Provenance: The consumer study was conducted "at five geographically distinct locations" within the USA. It used "coded specimens," which implies a prospective study design where participants were given samples to test.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The text does not specify the number or qualifications of experts for judging the reference methods in the clinical correlation study (Quidel RapidVue and Syntron Bioresearch Be Sure Pregnancy Test).
For the lay-user study:
- Ground Truth: The "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." This indicates laboratory-prepared samples with known hCG concentrations.
- Experts: No external experts were used to establish the ground truth for these specific samples; the ground truth was established by the deliberate spiking or absence of hCG by the study designers.

4. Adjudication Method for the Test Set

The text does not mention an adjudication method for either the clinical correlation study or the lay-user study.
For the lay-user study, the design involved individuals following instructions and potentially recording their own interpretations, which were then compared against the known ground truth of the spiked samples. There is no indication of a separate expert review or adjudication of the lay users' interpretations described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a traditional MRMC comparative effectiveness study that measures the improvement of human readers with AI vs. without AI assistance was not done.
- The device is a standalone immunoassay for qualitative detection of HCG, not an AI system designed to assist human readers in interpreting images or data.
- The "consumer survey" involved lay users performing and interpreting the test themselves, which is a form of human performance, but not in the context of assisting professional readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in essence, the "Performance" section describes the standalone performance of the device itself. The device is designed to be self-interpretable (visual color change) by a human user (either clinical professional or lay person).
- The "clinical sample correlation study" assesses the device's outcome against other commercial tests, which can be seen as a standalone comparison.
- The "blind labeled spiked consumer study" assesses the device's ability to accurately detect hCG in known positive/negative samples when interpreted by lay users, essentially testing the device's performance characteristics in the hands of its intended user without further professional intervention beyond the interpretation of the test result.

7. The Type of Ground Truth Used

For the clinical correlation study: The ground truth was established by the results of two other commercially available and established pregnancy tests (Quidel RapidVue and the Syntron Bioresearch Be Sure Pregnancy Test).
For the lay-user study: The ground truth was based on laboratory-prepared samples with known, controlled concentrations of hCG (40 mIU/mL hCG for positive samples and 0 mIU/mL hCG for negative samples). This is a form of spike-in ground truth.

8. The Sample Size for the Training Set

The text does not mention a training set. This device is an immunoassay (a chemical test), not an AI algorithm that requires a training set. The "samples" referred to in the performance studies are for validation of the device's performance, not for training a model.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a training set for an AI algorithm, this question is not applicable based on the provided text.

Summary

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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.

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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

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INDICATIONS FOR USE

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

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

Regulation Number and Section

§ 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.