(46 days)
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. This device is intended for clinical laboratories (labs) and physician's office labs (POLs) as an IVD test for the qualitative measurement of hCG in urine. Clinical labs can include hosptials and reference labs. POLs can include mini-clinics.
Immunoassay for the Qualitative Detection of Human Chorionic Gonadotropin (hCG) in Urine for the Early Pregnancy. The QuickStick ProTM HCG Test, like many commercially available pregnancy test kits, qualitatively measures the presence of HCG by visual color sandwich one step immunoassay technology.
The provided text describes the 510(k) summary for the QuickStick Pro™ HCG Test, a device intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine for early pregnancy confirmation.
Here's an analysis of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria in a quantitative numerical format (e.g., "sensitivity must be >95%"). However, it implies the acceptance criteria by stating that the QuickStick Pro™ HCG Test exhibited "excellent sensitivity (>99%), specificity (>99%), and accuracy (>99%)" and a ">99% correlation" with predicate devices. This suggests that achieving high percentages in these metrics was the de facto acceptance benchmark, aligned with the performance of substantially equivalent devices.
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sensitivity | >99% | >99% |
| Specificity | >99% | >99% |
| Accuracy | >99% | >99% |
| Correlation | >99% with predicate devices | >99% with predicate devices |
2. Sample Size Used for the Test Set and Data Provenance
The text states that "Correlations studies, using clinical specimens, produced a >99% correlation." It also mentions "A clinical laboratory study was performed."
- Sample Size: The document does not explicitly state the sample size used for the test set or clinical studies.
- Data Provenance: The data came from "clinical specimens" and "a clinical laboratory study." The country of origin is not specified, and it is described as a "clinical sample correlation study," which implies it was based on retrospective clinical samples or a prospective collection during a clinical study. The blind labeled spiked HCG study would involve a controlled, possibly laboratory-based, prospective experiment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing the ground truth. It vaguely refers to "professional users" for the clinical laboratory study, but this refers to the users operating the device, not necessarily those establishing the ground truth.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done as described in the provided text. The study conducted was a correlation study against predicate devices and a clinical laboratory study, focusing on the device's standalone performance in the hands of "professional users," not specifically on comparing human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, a standalone performance evaluation was conducted. The QuickStick Pro™ HCG Test is a qualitative immunoassay kit. The "clinical laboratory study" and "blind labeled spiked HCG study" focused on the performance characteristics (sensitivity, specificity, accuracy) of the device itself (the "algorithm only," in the context of an immunoassay) when handled by "professional users." The device provides a visual result, which is then interpreted by a human, but the core performance metrics are intrinsic to the device's ability to detect hCG. The "correlation" studies compare its results directly with predicate devices.
7. The Type of Ground Truth Used
The ground truth for the clinical sample correlation study and the clinical laboratory study likely relied on one or a combination of the following, although not explicitly stated:
- Reference Laboratory Testing: Comparison with established, more sensitive, or quantitative laboratory tests for hCG.
- Predicate Device Results: The text explicitly mentions correlation against Quidel Rapidvue and Syntron Bioresearch Be Sure Pregnancy Test, indicating their results served as a form of "ground truth" or reference for comparison.
- Clinical Confirmation/Outcomes Data: For actual pregnancy status, clinical confirmation or follow-up outcomes would typically be used, though not detailed here.
- Spiked HCG Samples: For the "blind labeled spiked HCG study," the ground truth was the known concentration of hCG that was intentionally added (spiked) into the samples.
8. The Sample Size for the Training Set
The document does not provide information on a separate "training set" or its sample size. This is a characteristic typically associated with machine learning or AI algorithm development, which is not the focus of this immunoassay device approval. The studies described are for validation of the finalized product.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set" in the context of this device's development and validation, this information is not applicable or provided in the document. Immunoassay devices like the QuickStick Pro™ are typically developed based on established biochemical principles and then validated through performance studies, rather than "trained" on data.
{0}------------------------------------------------
JAN 26 1998
510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)
QuickStick ProTM HCG Test (9009) ldentification:
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
Intended Use: The QuickStick ProTM HCG Test is intended to detect the presence of Human Chorionic Gonadotropin (hCG) in Urine. 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. This device is intended for clinical laboratories and physician's office labs as an IVD test for the qualitative measurement of hCG in urine.
The QuickStick ProTM HCG Test, like many commercially available Technology: 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 QuickStick ProTM 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 Pro™ HCG 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 clinical laboratory study was performed, the Phamatech QuickStick ProTM exhibited excellent sensitivity (>99%), specificity (>99%), and accuracy (>99%) in the hands of professional users.
Conclusion: For the reasons mentioned above, it may be concluded that the Phamatech QuickStick ProTM HCG Test is substantially equivalent to a variety of pregnancy tests currently in commercial distribution.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo features a stylized eagle with three stripes forming its wing, symbolizing strength and protection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the eagle, indicating the department's name and country.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 26 1998
Carl Mongiovi Director of Operations Phamatech 9265 Activity Road #112-113 San Dieqo, California 92126
Re : K974615 QuickStick Pro™ HCG Test Regulatory Class: II Product Code: JHI Dated: December 10, 1997 Received: December 11, 1997
Dear Mr. Mongiovi:
regulations.
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 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 Requlations, Title 21, Parts 800 to 895. ದ 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 Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory In addition, FDA may publish further announcements action. 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
{2}------------------------------------------------
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 Bitman
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
{3}------------------------------------------------
INDICATIONS FOR USE
Applicant: Phamatech
510(k) Number (if known): _
Device Name: QuickStick Pro IM Pregnancy Test
Indications for Use:
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. This device is intended for clinical laboratories (labs) and physician's office labs (POLs) as an IVD test for the qualitative measurement of hCG in urine. Clinical labs can include hosptials and reference labs. POLs can include mini-clinics.
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:
Per 21 CFR 801.109
OR Over the Counter -
Kmoore for Montgomery
(Division Sign-Off)
11
Division of Clinical Laboratory Devices
510(k) Number 974615
§ 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.