(27 days)
This test detects hCG in urine or serum. hCG is a hormone produced by the placenta shortly after implantation. Since hCG is present in the urine and serum of a pregnant woman, it is an excellent marker for confirming pregnancy. This device is intended for clinical laboratories and physician's office laboratories (POL's) as an IVD test for the qualitative measurement of hCG in urine or serum.
The QuickCard hCG Combo Test, like many commercially available preqnancy test kits, qualitatively measures the presence of HCG by visual color sandwich one step immunoassay technology.
The QuickCard hCG Combo Test, an immunoassay for detecting Human Chorionic Gonadotropin (hCG) in urine or serum, was evaluated through a clinical sample correlation study and a blind labeled spiked hCG study.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| N/A (not explicitly stated in the provided text, but implied to be high correlation) | >98% correlation compared to predicate devices (QuickVue, Phamatech QuickCard hCG Pregnancy Test (9008), Abbott Test Pack Plus) |
2. Sample Size and Data Provenance
- Test Set Sample Size: Not explicitly stated. The document mentions "clinical specimens" and "a blind labeled spiked hCG study."
- Data Provenance: Not explicitly stated. Given the manufacturer is Phamatech in San Diego, California, USA, and the FDA submission, it is likely that the studies were conducted in the USA. The studies involved both "clinical sample correlation" (suggesting prospective or retrospective clinical samples) and "blind labeled spiked hCG study" (suggesting controlled, laboratory-generated samples).
3. Number of Experts and Qualifications
Not applicable. The ground truth method described does not involve expert readers.
4. Adjudication Method
Not applicable. The ground truth method described does not involve expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The provided document evaluates the device's performance against predicate devices, not against human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Yes. The study focused on the performance of the QuickCard hCG Combo Test itself, comparing its results directly with predicate devices and spiked samples. This is a standalone performance evaluation of the device.
7. Type of Ground Truth Used
The ground truth was established by comparing the device's results to:
- Results from commercially available predicate devices: QuickVue, Phamatech QuickCard hCG Pregnancy Test (9008), and Abbott Test Pack Plus. These predicate devices are established methods for hCG detection, and their results served as a comparative ground truth.
- Known concentrations in "blind labeled spiked hCG study": This implies that hCG was added to samples at known concentrations, providing a controlled ground truth for accuracy.
8. Sample Size for the Training Set
Not applicable. This device is an immunoassay, not an AI/ML model, so there is no "training set" in the context of machine learning. The studies described are for validation of the chemical assay.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an immunoassay.
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4/28/99
K 9910895
510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)
QuickCard hCG Combo Test (9014) ldentification:
Immunoassay for the Qualitative Detection of Human Chorionic Description: Gonadotropin (hCG) in Urine or Serum for the Early Pregnancy
Name Of Manufacturer:
Phamatech 9265 Activity Road #112 San Diego, California 92126, USA
The QuickCard hCG Combo Test is intended to detect the Intended Use: presence of Human Chorionic Gonadotropin (hCG) in urine or Serum. 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 urineor serum.
The QuickCard hCG Combo Test, like many commercially available Technology: preqnancy 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' Test Pack 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 hCG Combo 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 Combo 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 >98% correlation when compared to the Quickvue (San Diego, CA 92121), the Phamatech QuickCard hCG Pregnancy Test (9008) and the Abbott Test Pack Plus (Abbott Park, III.).
For the reasons mentioned above, it may be concluded that the Conclusion: Phamatech QuickCard hCG Combo Test is substantially equivalent to a variety of pregnancy tests currently in commercial distribution.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
APR 2 8 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Carl A. Mongiovi Vice President of Operations Phamatech 9265 Activity Road #112 San Diego, California 92126
Re: K991095
Trade Name: Phamatech OuickCard™ hCG Combo Test Regulatory Class: II Product Code: JHI Dated: March 31, 1999 Received: April 1, 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 Quality 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 Putman
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): _ 99 j095
Device Name:_QuickCard™ hCG Combo Test
Indications for Use:
)
Status and
This test detects hCG in urine or serum. hCG is a hormone produced by the placenta shortly after implantation. Since hCG is present in the urine and serum of a pregnant woman, it is an excellent marker for confirming pregnancy. This device is intended for clinical laboratories and physician's office laboratories (POL's) as an IVD test for the qualitative measurement of hCG in urine or serum.
Tean Cooper
(Division Sign-Off) Division of Clinical Laboratory Devices x 191695 510(k) Number _
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: | |
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| Prescription Use: | ✓ | OR | Over the Counter: | |
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| Per 21 CFR 801.109 |
§ 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.