(24 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.
Immunoassay for the Qualitative Detection of Human Chorioni Gonadotropin (hCG) in Urine for the Early Pregnancy. The QuickCard Pro™ HCG Test, like many commercially available pregnancy test kits, qualitatively measures the presence of HCG by visual color sandwich one step immunoassay technology.
Here's an analysis of the provided text regarding the QuickCard Pro™ HCG Test, focusing on acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Correlation to Predicate Devices | Substantially equivalent to commercially available tests, >99% correlation | >99% correlation (compared to Quidel Rapidvue and Syntron Bioresearch Be Sure) |
| Sensitivity | >99% | >99% |
| Specificity | >99% | >99% |
| Accuracy | >99% | >99% |
Note: The acceptance criteria are "implied" because the document states the device needs to be "substantially equivalent to the reported performance characteristics of other commercially available tests" and then reports actual performance which exceeds 99% for all metrics. It doesn't explicitly state "acceptance criteria must be >99%" but this is the threshold achieved for substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
The document states:
- "The product performance characteristics of the QuickCard Pro™ HCG Pregnancy Test were evaluated in a clinical sample correlation study and a blind labeled spiked HCG study."
- "Correlations studies, using clinical specimens, produced a >99% correlation..."
- "A clinical laboratory study was performed..."
Sample Size: The exact sample size for the test set is not explicitly stated in the provided text.
Data Provenance: The data came from "clinical sample correlation study" and "clinical laboratory study" using "clinical specimens." This suggests prospective collection from human subjects, although the specific country of origin is not mentioned. Given the manufacturer's location (San Diego, California, USA) and the FDA submission, it's highly probable the studies were conducted in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document makes no mention of specific "experts" used to establish ground truth or their qualifications. The ground truth for this type of immunoassay is typically derived from the results of a highly accurate reference method or a predicate device.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method. For a quantitative test like hCG detection, adjudication (e.g., 2+1 or 3+1 reader consensus) is generally not applicable in the same way it would be for subjective image interpretation. The outcome (positive/negative for hCG) is typically determined by a threshold or comparison to a reference.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed. This is not typically relevant for a simple positive/negative immunoassay where human interpretation is minimal beyond observing a color change. The study evaluated the device's performance directly, not how human readers improve with or without AI assistance, as "AI" is not involved in this device.
6. Standalone (Algorithm Only) Performance
This device is a standalone test (an immunoassay), and its performance metrics (sensitivity, specificity, accuracy, correlation) directly represent its "standalone" performance. There is no human-in-the-loop component in the evaluation of its core analytical function; it produces a result based on the chemical reaction. The "professional users" in the clinical laboratory study are performing the test according to instructions and observing its output, not providing an independent interpretation that is then augmented by the device.
7. Type of Ground Truth Used
The ground truth was established by:
- Comparison to predicate devices: "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)." These predicate devices themselves would have established their accuracy against a recognized gold standard for hCG detection (e.g., a laboratory reference assay or clinical confirmation).
- "Blind labeled spiked HCG study": This indicates that samples with known, controlled concentrations of hCG (both positive and negative) were used, providing a definitive ground truth.
Therefore, the ground truth is a combination of reference device comparison and known spiked samples, which themselves are validated against established medical science for hCG detection.
8. Sample Size for the Training Set
The document does not mention a training set size. This device is an immunoassay, not a machine learning or AI-based diagnostic tool that would typically involve a "training set" in the computational sense. Its performance is based on the chemical principle and validation with physical samples.
9. How the Ground Truth for the Training Set Was Established
As there is no concept of a "training set" for this type of immunoassay in the context of an algorithm, the question of how ground truth was established for it is not applicable. The device's design and manufacturing are based on established immunochemical principles, not on iterative machine learning from a dataset.
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APR - 2 1998
510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)
QuickCard Pro™ HCG Test (9008) Identification:
Description: Immunoassay for the Qualitative Detection of Human Chorioni Gonadotropin (hCG) in Urine for the Early Pregnancy
Name Of Manufacturer:
Phamatech 9265 Activity Road #112 San Diego, California 92126, USA
Intended Use: The QuickCard Pro™ 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.
Technology: The QuickCard Pro™ HCG 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), 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 QuickCard Pro™ 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 QuickCard 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 QuickCard Pro™ exhibited excellent sensitivity (>99%), specificity (>99%), and accuracy (>99%) in the hands of professional users.
For the reasons mentioned above, it may be concluded that the Conclusion: Phamatech QuickCard Pro™ HCG 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 features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR - 2 1998
Carl Mongiovi Director of Operations Phamatech 9265 Activity Road #112 San Diego, California 92126
Re : K980896 QuickCard Pro™ HCG Test(9008) Regulatory Class: II Product Code: JHI Dated: March 5, 1998 Received: March 9, 1998
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 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. ਸੋ 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 regulatory 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 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/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 Pro hCG 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.
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: /
OR
Over the Counter: _
Per 21 CFR 801.109
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K980896
§ 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.