(28 days)
The InSure Pregnancy Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine for the detection of early pregnancy. This test is intended for laboratory or professional use only.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the InSure Pregnancy Test. It indicates that the device has been found substantially equivalent to a legally marketed predicate device. However, this document does not contain the detailed study information, acceptance criteria, or performance data that would be required to answer your specific questions about the device's acceptance criteria and the study proving it meets them.
The letter explicitly states: "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..." This means the FDA found the device to be comparable to an existing device, but the letter itself does not provide the underlying study data.
To get the information you're asking for, one would typically need to review the original 510(k) submission document (K991515) itself, which includes the detailed performance data and study protocols provided by InBios International, Inc. to the FDA. Unfortunately, this specific letter does not contain that level of detail.
Therefore, for each of your questions, the answer based solely on the provided text would be:
1. A table of acceptance criteria and the reported device performance
- Response: Not available in this document. The document is a clearance letter, not the performance study report itself.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Response: Not available in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Response: Not applicable. This is an in vitro diagnostic device (pregnancy test), not an imaging or diagnostic device that typically involves human expert interpretation for ground truth establishment. Clinical studies for such devices usually involve comparing the test's results to a gold-standard chemical assay or confirmed clinical outcome. The document does not provide details on such a study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Response: Not applicable. See response to #3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Response: Not applicable. This is an in vitro diagnostic device, not an AI-assisted diagnostic tool that involves human readers interpreting images or data with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Response: Not applicable. This is a manual in vitro diagnostic test. Its standalone performance would be its accuracy, sensitivity, and specificity in detecting hCG, but the document does not provide these metrics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Response: Not available in this document. For a pregnancy test, ground truth would typically be established through a confirmatory chemical method (e.g., quantitative hCG assay) or clinical follow-up, but the document does not specify.
8. The sample size for the training set
- Response: Not available in this document. (For an IVD like this, the concept of a "training set" in the context of machine learning isn't directly applicable unless an AI component was involved, which is not indicated for this 1999 device. There would be a clinical study or verification/validation sample size, but it's not specified here.)
9. How the ground truth for the training set was established
- Response: Not available in this document. (See response to #8.)
In summary, the provided FDA clearance letter ("K991515") confirms that the InSure Pregnancy Test was found substantially equivalent, but it does not contain the detailed technical, performance, or study data necessary to answer your specific questions. These details would be in the original 510(k) submission itself.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Public Health Service
Estela I. Raychaudhuri President InBios International, Inc. 562 1st Ave. South, Suite 600 Seattle, WA 98104
MAY 2 8 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Re: K991515 Trade Name: InSure Pregnancy Test Requlatory Class: II Product Code: JHI Dated: May 17, 1999 Received: May 24, 1999
Dear Ms. Raychaudhuri:
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 (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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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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K991515 510(k) Number (if known): ___
InSure Pregnancy Test Device Name:
Indications For Use:
The InSure Pregnancy Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine for the detection of early pregnancy. This test is intended for laboratory or professional use only.
Jean Cooper
Divider Sign Off
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number_14991515
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.