(27 days)
Unipath Clearview HCG, Abbott Laboratories' Test Pack Plus, Syntron Bioresearch Be Sure Pregnancy Test
Not Found
No
The device description explicitly states it uses "visual color sandwich one step immunoassay technology," which is a traditional, non-AI/ML method. There are no mentions of AI, ML, or related concepts in the provided text.
No
This device is a qualitative diagnostic test for hCG, used to confirm pregnancy by detecting a marker, not to treat a condition.
Yes
Explanation: The device is described as an "IVD test for the qualitative measurement of hCG in urine or serum," which is used to confirm pregnancy by detecting a marker. This aligns with the definition of a diagnostic device as it aims to identify a condition (pregnancy) based on specific biological markers.
No
The device description clearly states it is a "visual color sandwich one step immunoassay technology," which is a physical test kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "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."
- Device Description: The description details a test that analyzes biological samples (urine or serum) to detect a specific marker (hCG) for a medical condition (pregnancy). This is the core function of an IVD.
- Performance Studies: The document describes clinical studies evaluating the performance of the device in detecting hCG in clinical samples, which is typical for IVD validation.
- Predicate Devices: The mention of predicate devices (other commercially available pregnancy tests) further confirms its classification as an IVD, as predicate devices are used for comparison in the regulatory process for IVDs.
N/A
Intended Use / Indications for Use
The QuickCard hCG Combo Test is intended to detect the 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.
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.
Product codes
JHI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratories and physician's office labs
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
98% correlation
Predicate Device(s)
Unipath Clearview HCG, Abbott Laboratories' Test Pack Plus, Syntron Bioresearch Be Sure Pregnancy Test
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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
3
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
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| Per 21 CFR 801.109 |