(19 days)
Not Found
No
The device description and performance studies describe a standard lateral-flow immunoassay, which relies on chemical reactions and visual interpretation, not AI/ML. There are no mentions of AI, ML, or related concepts.
No.
The device is for the qualitative detection of hCG in urine for the early detection of pregnancy, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is described as aiding in the "early detection of pregnancy" by qualitatively detecting hCG in urine. Detection is a form of diagnosis, even if it's for home use and not professional medical diagnosis.
No
The device description clearly indicates a physical, lateral-flow immunoassay test strip, which is a hardware component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "qualitative detection of hCG in urine as an aid in the early detection of pregnancy." This involves testing a biological sample (urine) outside of the body to provide information about a physiological state (pregnancy).
- Device Description: The description details a "rapid immunoassay" that uses antibodies to detect a specific analyte (hCG) in a sample. This is a common characteristic of IVD devices.
- Nature of the Test: The test analyzes a biological specimen (urine) to provide diagnostic information (presence or absence of hCG, indicating pregnancy).
The fact that it's intended for "over-the-counter home use" doesn't change its classification as an IVD. Many IVD devices are designed for use by lay users in a home setting.
N/A
Intended Use / Indications for Use
The test is a rapid immunoassay for the qualitative detection of hCG in urine as an aid in the early detection of pregnancy. The test is intended for overthe-counter home use.
The Quidel Home Pregnancy Test is intended for the qualitative detection of hCG in urine for the early detection of pregnancy. The test is for over-the-counter home use.
Product codes
LCX
Device Description
The test, a sandwich-format, lateral-flow immunoassay, employs monoclonal and polyclonal antibodies. If the sample contains hCG, a pink Test Line along with a blue Control Line is visible in the large Result Window to indicate a positive result. If hCG is not present in the sample, only the blue Control Line is visible in the large Result Window to indicate a negative result.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
over-the-counter home use.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Numerous studies were undertaken to document the performance characteristics and the substantial equivalence of the test to other commercially available products for the qualitative detection of hCG. These studies included the following:
- The test was shown to be similar to other commercially distributed tests in terms of features and intended use.
- · The test was shown to have excellent intra- and inter-assay precision.
- · Lot-to-lot consistency analyses showed the test to be reproducibly manufacturable.
- · Common drugs, chemicals, and biologicals were shown not to interfere with the test's performance.
- A consumer study was conducted in order to show that lay users could read the package insert, perform the test and obtain results similar to results obtained by clinic personnel.
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
JUN 3 1998
SUMMARY OF SAFETY AND EFFECTIVENESS XI.
Product OUIDEL Home Pregnancy Test
Manufacturer
QUIDEL Corporation 10165 McKellar Court San Diego, CA 92121 U.S.A.
Device Classification
The device, Quidel Home Pregnancy Test, is similar to other FDA-cleared devices used for the qualitative detection of human chorionic gonadotropin (hCG). The test is used in the early detection of pregnancy and is intended to measure hCG, a placental hormone, in urine (21 CFR 862.1155). The FDA has proposed that hCG test systems be classified as Class II.
Intended Use
The test is a rapid immunoassay for the qualitative detection of hCG in urine as an aid in the early detection of pregnancy. The test is intended for overthe-counter home use.
Physiologic Basis for the Assay
Human chorionic gonadotropin (hCG) is a glycoprotein hormone secreted by the trophoblastic cells of the developing placenta as early as 7 to 8 days after ovulation. This hormone stimulates the production of progesterone and estradiol which are required to sustain pregnancy. In normal pregnancy, serum levels of hCG continue to rise during the first trimester to levels as high as 100,000 mIU/mL. Serum hCG is rapidly cleared in the urine and the concentration of hCG in serum is approximately equal to the concentration in urine. HCG is an excellent indicator of pregnancy early in the gestational period.
1
Principle of the Test
The test, a sandwich-format, lateral-flow immunoassay, employs monoclonal and polyclonal antibodies. If the sample contains hCG, a pink Test Line along with a blue Control Line is visible in the large Result Window to indicate a positive result. If hCG is not present in the sample, only the blue Control Line is visible in the large Result Window to indicate a negative result.
Safety and Effectiveness
Numerous studies were undertaken to document the performance characteristics and the substantial equivalence of the test to other commercially available products for the qualitative detection of hCG. These studies included the following:
- The test was shown to be similar to other commercially distributed tests in terms of features and intended use.
- · The test was shown to have excellent intra- and inter-assay precision.
- · Lot-to-lot consistency analyses showed the test to be reproducibly manufacturable.
- · Common drugs, chemicals, and biologicals were shown not to interfere with the test's performance.
- A consumer study was conducted in order to show that lay users could read the package insert, perform the test and obtain results similar to results obtained by clinic personnel.
Conclusion
These studies demonstrated the substantial equivalence of the test to existing products already marketed. They further demonstrated the suitability of the product for over-the-counter home use. Such studies are a critical element in establishing the fundamental safety and effectiveness of the product and its appropriateness for commercial distribution.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
3 1698 JUN
McMullen E. Joseph Manager, Regulatory Compliance Quidel Corporation 10165 McKellar Court San Diego, California 92121
Re : K981722 Quidel Home Pregnancy Test Regulatory Class: II Product Code: LCX Dated: May 14, 1998 Received: May 15, 1998
Dear Mr. McMullen:
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. ਬੈ 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 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 notethe 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 Sitman
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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1_ Page _________________________________________________________________________________________________________________________________________________________________________
re 98 510(k) Number (if known):
Device Name:
Quidel Home Pregnancy Test
Indications for Use:
The Quidel Home Pregnancy Test is intended for the qualitative detection of hCG in urine for the early detection of pregnancy. The test is for over-the-counter home use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Over-The Counter Use OR Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96) (Division Simi-C in Division . Il succe 510(k) Number