(23 days)
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No
The 510(k) summary describes a simple dipstick test for pregnancy, which is a chemical reaction-based diagnostic. There is no mention of AI, ML, image processing, or any computational analysis that would suggest the use of such technologies.
No
The device is a diagnostic test for pregnancy, not a therapeutic device designed to treat or alleviate a medical condition.
Yes
The device is intended for the "qualitative determination of human chorionic gonadotropin (hCG), in urine for early detection of pregnancy," which directly relates to diagnosing pregnancy.
No
The device is described as a "HCG Pregnancy Dipstick Test," which is a physical diagnostic test kit, not a software-only device.
Yes, based on the provided information, the San Diego Biotech HCG Pregnancy Dipstick Test is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative determination of human chorionic gonadotropin (hCG), in urine". This involves testing a biological sample (urine) outside of the body to diagnose a condition (pregnancy).
- Sample Type: It uses urine, which is a biological specimen.
- Purpose: It's used for the "early detection of pregnancy," which is a diagnostic purpose.
These characteristics align perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The San Diego Biotech HCG Pregnancy Dipstick Test is intended for the qualitative determination of human chorionic gonadotropin (hCG), in urine for early detection of pregnancy. This test is intended for professional and Laboratory use only.
Product codes
JHI75
Device Description
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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
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Intended User / Care Setting
professional and Laboratory use only.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 1 2 1998
Chai Bunyaqidj, Ph.D. President SAN DIEGO BIOTECH 7919 Silverton Avenue, Suite 409-410 San Diego, CA 92126
Re: K980205 Trade Name: San Diego Biotech HCG Pregnancy Dipstick Test Requlatory Class: II Product Code: JHI 75 Dated: January 16, 1998 Received: January 20, 1998
Dear Dr. Bunyagidj:
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 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 The general controls provisions of the Act include Act. 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 A substantially Requlations, Title 21, Parts 800 to 895. 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 In addition, FDA may publish further regulatory action. announcements concerning your device in the Federal Register. this response to your premarket notification Please note: 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 requlation 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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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II. DEVICE INDICATION FOR USE
510 (k) Number: K980205 (To Be Assigned)
Device Name: San Diego Biotech HCG Pregnancy Dipstick Test
Indication For Use:
: :
The San Diego Biotech HCG Pregnancy Dipstick Test is intended for the qualitative determination of human chorionic gonadotropin (hCG), in urine for early detection of pregnancy. This test is intended for professional and Laboratory use only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED|
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K980205 |
| Prescription Use
| (Per 21 CFR 801.109) | OR Over The Counter Use |
|---|---|
| ------------------------------------------ | ------------------------- |