(48 days)
Over the Counter hCG Pregnancy tests are for those individuals who, for any reason, believe they may be pregnant. This test detects hCG in urine. HCG is a hormone produced by the placenta shortly after implantation. Since hCG is present in the urine of a pregnant woman, it is an excellent marker for confirming pregnancy. Early identification is important in the management of pregnancy. This condition must be identified so that fetal exposure to potentially harmful circumstance may be minimized or eliminated. Many individuals hesitate to seek clinical confirmation of this condition (pregnancy) due to medical examination costs and appointment scheduling difficulties. This device offers an alternative to the initial office visit and will allow for more rapid initiation of pre-natal care upon confirmation testing by trained clinical technicians.
Immunoassay for the qualitative detection of hCG in urine
Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets those criteria:
Device: At Home™ QuickCup Pregnancy Test (Model 9015)
Intended Use: Qualitative detection of hCG in urine for women who suspect they may be pregnant.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in numerical terms (e.g., "sensitivity must be >95%"). Instead, the document relies on a comparison to predicate devices and a general statement of "excellent accuracy." However, the performance reported for the device can be inferred as exceeding 99% agreement or accuracy.
| Acceptance Criteria (Inferred) | Reported Device Performance | Comments |
|---|---|---|
| Substantial equivalence to predicate devices | >99% correlation with Quidel Rapidvue and Syntron Bioresearch Be Sure Pregnancy Test | This indicates the device performs at least as well as established, legally marketed devices. |
| Excellent accuracy in lay user hands | Exceeding 99% accuracy | This addresses the performance when used by the intended lay user. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated for either study.
- Data Provenance:
- Clinical Sample Correlation Study: Implied to be clinical specimens, but no country of origin is mentioned. The study is retrospective as it used clinical specimens likely collected prior to the study.
- Blind Labeled Spiked HCG Study (Consumer Study): This study involved "spiked HCG," meaning HCG was artificially added to samples. It was a "blind labeled" study for consumers. No country of origin is mentioned. It appears to be a prospective usability/performance study with contrived samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number or qualifications of experts used to establish ground truth for the test set.
- For the Clinical Sample Correlation Study, the predicate devices (Quidel Rapidvue and Syntron Bioresearch Be Sure Pregnancy Test) were used as comparators, implying their results were considered the "ground truth" for those samples. The expertise behind the predicate devices' results is not detailed.
- For the Blind Labeled Spiked HCG Study, the "ground truth" would be known by definition, as the HCG was "spiked" into samples, so the presence or absence of HCG was controlled by the study designers.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1). It states "correlations studies, using clinical specimens, produced a >99% correlation when compared to the Quidel Rapidvue... and the Syntron Bioresearch Be Sure Pregnancy Test." This implies direct comparison, rather than an adjudication process involving multiple independent readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The studies described are:
- A clinical correlation study against predicate devices.
- A blind labeled spiked consumer study to assess accuracy in lay users.
The device is a qualitative home-use test, not an imaging or diagnostic device where MRMC studies with human readers are typically conducted. Therefore, there is no mention of an effect size for human readers improving with AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
Yes, the studies described assess the device's standalone performance. The "At Home™ QuickCup Pregnancy Test" is a self-contained immunoassay intended for direct visual interpretation by the user. The performance claims of ">99% correlation" and "exceeding 99% accuracy" are directly attributed to the device itself, without any human-in-the-loop assistance other than the user interpreting the visual result for the lay-user study.
7. The Type of Ground Truth Used
- Clinical Sample Correlation Study: The ground truth was established by the results of two commercially available and accepted predicate devices (Quidel Rapidvue and Syntron Bioresearch Be Sure Pregnancy Test). This is a form of comparative ground truth against established gold standards in the field.
- Blind Labeled Spiked HCG Study: The ground truth was based on the known presence or absence of HCG in the samples, as they were "spiked" by the study designers. This is a contrived/known ground truth.
8. The Sample Size for the Training Set
The document does not mention a training set. This device is an immunoassay, not an AI/machine learning model, so the concept of a "training set" in that context does not apply. The "performance" section describes validation studies.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for an AI/machine learning model, this question is not applicable to the provided information. The ground truth for the validation/performance studies was established as described in section 7.
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NOV - 8 1999
510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)
ldentification: At Home QuickCup Pregnancy Test (Model 9015)
Description: Immunoassay for the qualitative detection of hCG in urine
Phamatech Name Of Manufacturer: 9265 Activity Road #112 San Diego, California 92126, USA
lintended Use: The At Home™ QuickCup Pregnancy Test is intended to detect the presence of Human Chorionic Gonadotropin (hCG) in Urine for the women who suspect they may be foregnant. HCG is a well known 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 At Home™ QuickCup Pregnancy Test, like many commercially available foregnancy 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), Abbott Laboratories' Fact Plus (Abbott Park, IL (60064) and the Syntron Bioresearch Be Sure Pregnancy Test (Vista, CA 92083). 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 At Home™ QuickCup 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 At Home QuickCup Pregnancy Test to be substantially equivalent to the reported performance characteristics of other commercially available tests for the qualitative detection of early pregnancy. Correlations 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 (Vista, CA 92083).
A blind labeled spiked consumer study was performed, the Phamatech At Home™ QuickCup Pregnancy Test exhibited excellent accuracy (exceeding 99%) in the hands of lay users.
For the reasons mentioned above, it may be concluded that the Conclusion: Phamatech At Home"" Pregnancy Test is substantially equivalent to a variety of pregnancy tests currently in commercial distribution.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA".
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV - 8 1999
Mr. Carl A. Mongiovi Vice President of Operations Phamatech 9265 Activity Road Suite 112 San Diego, California 92126
Re: K993141
Trade Name: At Home™ QuickCup Pregnancy Test Regulatory Class: II Product Code: LCX Dated: September 9, 1999 Received: September 21, 1999
Dear Mr. Mongiovi:
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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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 regulations.
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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 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 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/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
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): _K 99314)
Device Name: At Home™ QuickCup Pregnancy Test
Indications for Use:
Over the Counter hCG Pregnancy tests are for those individuals who, for any reason, believe they may be pregnant. This test detects hCG in urine. HCG is a hormone produced by the placenta shortly after implantation. Since hCG is present in the urine of a pregnant woman, it is an excellent marker for confirming pregnancy. Early identification is important in the management of pregnancy. This condition must be identified so that fetal exposure to potentially harmful circumstance may be minimized or eliminated. Many individuals hesitate to seek clinical confirmation of this condition (pregnancy) due to medical examination costs and appointment scheduling difficulties. This device offers an alternative to the initial office visit and will allow for more rapid initiation of pre-natal care upon confirmation testing by trained clinical technicians.
Sean Conroy
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K993141
PLEASE DO NOT WRITE BELOW THIS LINE
Concurrence of the CDRH Office of Device Evaluation (ODE)
Division Sign-off Division of Clinical Laboratory Devices 510 (k) Number:
Prescription Use: Per 21 CFR 801.109 OR
Over the Counter:
§ 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.