(15 days)
Over-the-Counter HCG (pregnancy) tests are for the greating 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 tests by trained clinical technicians.
The QuickstickTM One Step HCG Pregnancy Test, like many commercially available pregnancy test kits, qualitatively measures the presence of HCG by visual color sandwich one step immunoassay technology.
Here's a breakdown of the acceptance criteria and study information for the Quickstick™ One Step HCG Pregnancy Test based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text doesn't explicitly state quantitative acceptance criteria in a traditional sense (e.g., "sensitivity must be >95%"). Instead, it compares the Quickstick™ to predicate devices and reports its performance as "substantially equivalent" and "excellent."
| Performance Metric | Acceptance Criteria (Implied / Comparator) | Reported Device Performance (Quickstick™) |
|---|---|---|
| Correlation | >99% correlation with predicate devices | >99% correlation when compared to the Quidel Rapidvue and the Syntron Bioresearch Be Sure Pregnancy Test (clinical sample correlation study) |
| Sensitivity | "Excellent" compared to other commercial tests | Excellent sensitivity (122/123) in the hands of lay users (blind labeled spiked consumer study) |
| Specificity | "Excellent" compared to other commercial tests | Excellent specificity (122/123) in the hands of lay users (blind labeled spiked consumer study) |
| Accuracy | "Excellent" compared to other commercial tests | Excellent accuracy (244/246) in the hands of lay users (blind labeled spiked consumer study) |
2. Sample Size Used for the Test Set and Data Provenance
- Clinical Sample Correlation Study:
- Sample Size: Not explicitly stated, but clinical specimens were used.
- Data Provenance: Not specified (e.g., country). Assumed to be retrospective or a mix of retrospective/prospective clinical samples.
- Blind Labeled Spiked Consumer Study:
- Sample Size: 246 total tests (123 positive, 123 negative based on sensitivity/specificity results).
- Data Provenance: Not specified (e.g., country). Appears to be a prospective study designed to mimic home use.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Clinical Sample Correlation Study: The ground truth was established by comparison with two predicate devices (Quidel Rapidvue and Syntron Bioresearch Be Sure Pregnancy Test). The qualifications of the personnel performing these predicate tests are not provided, nor is the number of experts involved in determining the "correlation."
- Blind Labeled Spiked Consumer Study: The "spiked" nature of this study implies that the HCG levels were known and controlled. The "ground truth" (i.e., whether HCG was present or absent) was established by the spiking process itself. No external experts were used to establish this particular ground truth, as it was artificially created.
4. Adjudication Method for the Test Set
Not applicable. The studies involved direct comparison to predicate devices or known spiked samples, rather than a process requiring expert adjudication of conflicting interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a rapid diagnostic test, not an AI-assisted diagnostic tool for human readers. The "blind labeled spiked consumer study" involved "lay users" as opposed to expert readers in an MRMC context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in essence. The Quickstick™ is a standalone, one-step immunoassay. Its performance is evaluated on its own ability to detect hCG in urine, whether in a clinical setting ("clinical sample correlation study") or by lay users ("blind labeled spiked consumer study"). There is no separate algorithm or human-in-the-loop component beyond the user interpreting a visual color change.
7. The Type of Ground Truth Used
- Clinical Sample Correlation Study: Ground truth was established by comparing to predicate devices (Quidel Rapidvue and Syntron Bioresearch Be Sure Pregnancy Test), which are themselves established diagnostic methods for hCG. This implies that the ground truth for these predicate devices would likely be based on established clinical laboratory methods or other highly sensitive and specific assays for hCG.
- Blind Labeled Spiked Consumer Study: The ground truth was based on known HCG concentrations in spiked samples. This is a form of engineered or controlled ground truth where the presence or absence of the analyte is precisely determined by the study design.
8. The Sample Size for the Training Set
Not applicable. This device is a chemical immunoassay, not a machine learning or AI-based device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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AUG - 1 - 1997
510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)
QuickstickTM One Step HCG Pregnancy Test (9010J) Identification:
Immunoassay for the Qualitative Detection of Human Chorionic Description: Gonadotropin (hCG) in Urine for the Early Pregnancy
Name Of Manufacturer:
Phamatech 9265 Activity Road #112 San Diego, California 92126, USA
The QuickstickTM One Step HCG Pregnancy Test is intended to Intended Use: detect the presence of Human Chorionic Gonadotropin (hCG) in Urine for the women who suspect they may be pregnant. 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.
The QuickstickTM One Step HCG Pregnancy Test, like many Technology: 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), 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 QuickstickTM One Step HCG 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 Quickstick™ One Step HCG 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 QuickstickTM 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 QuickstickTM One Step HCG Pregnancy Test is substantially equivalent to a variety of pregnancy tests currently in commercial distribution.
【出】【要】【
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Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an abstract eagle design, with three stylized profiles forming the body of the eagle. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle emblem.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUD - 1 1997
Tuan H. Pham President Phamatech 9265 Activity Road, #112 San Diego, California 92126
Re : K972682 Quickstick™ One Step HCG Pregnancy Test Regulatory Class: II Product Code: LCX Dated: July 17, 1997 Received: July 17, 1997
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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 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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Page 2
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/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: Quickstick IN One Step Pregnancy Test
Indications for Use:
Over-the-Counter HCG (pregnancy) tests are for the greating 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 tests by trained clinical technicians.
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 | K972682 |
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.