(73 days)
MidStream™ Home Pregnancy Test is intended for nonprofessional use for the identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy.
The test utilizes a combination of monoclonal and polyclonal antibody reagents to selectively detect elevated levels of hCG. The assay is conducted by urinating on the absorbent wick and observing for the formation of colored bands. The specimen migrates via capillary action along the wick and membrane to react with the colored conjugate. Positive specimens react with the specific antibody-hCG-colored conjugate and form a colored band on the Specimen portion of the membrane. Absence of this colored band suggests a negative result. To serve as a procedural control, a colored band at the Control Zone will always appear regardless of the presence or absence of hCG.
Here's a summary of the acceptance criteria and study details for the MidStream™ Home Pregnancy Test based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Detection of hCG at 25 mIU/ml and greater | Detects hCG concentrations of 25 mIU/ml and greater |
| No cross-reactivity with hLH, hFSH, hTSH | No cross-reactivity shown with hLH (500 mIU/ml), hFSH (1000 mIU/ml), and hTSH (1000 µIU/ml) |
| Overall agreement with laboratory results | Overall agreement of 99.1% |
| Ease of use by non-professional users | Majority of participants found the test very easy to use, had no trouble understanding labeling, instructions, or interpreting results |
| Suitable for over-the-counter pregnancy testing | Confirmed as suitable based on clinical trial results |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: 112 female participants.
- Data Provenance: Not explicitly stated, but implied to be from a clinical trial in the context of a US regulatory submission (FDA). The data is prospective as it involves actively testing participants and gathering their results, comparing them to laboratory results.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not explicitly state the number of "experts" used for establishing ground truth for the test set beyond the mention of "laboratory results." However, it implies that professional laboratory testing served as the reference standard. The qualifications of the personnel performing these laboratory tests are not detailed.
4. Adjudication Method for the Test Set
The document does not describe an explicit adjudication method (like 2+1 or 3+1). It states a "comparison study between the participants results and laboratory results," suggesting a direct comparison without complex adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study compares the self-interpretation of the home test by participants to laboratory results, not the performance of human readers with vs. without AI assistance. This device is a standalone diagnostic kit, not an AI-assisted diagnostic tool.
6. Standalone Performance
Yes, a standalone performance study was done. The entire clinical trial evaluates the device's performance (i.e., the algorithm/test strip's ability to detect hCG) when used by the intended non-professional users. The comparison is between the users' interpretations of the device's results and professional laboratory results.
7. Type of Ground Truth Used
The ground truth used was laboratory results, which would typically involve high-sensitivity quantitative or qualitative hCG assays performed by trained laboratory personnel.
8. Sample Size for the Training Set
The document does not specify a separate "training set" or its sample size. This is a traditional in-vitro diagnostic device, not a machine learning model, so the concept of a "training set" in the AI sense does not apply. The inherent design and components of the test (antibodies, membrane chemistry) are developed and refined through R&D, not through an iterative machine learning training process with a distinct training dataset.
9. How Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" in the context of an AI/ML model is not applicable here. The "ground truth" for the development of the test strip itself would be based on established biochemical principles of antigen-antibody detection, using known concentrations of hCG and other structurally similar hormones to ensure specificity and sensitivity during product development and manufacturing quality control.
{0}------------------------------------------------
"Summary of Safety & Effectiveness"
The MidStream™ Home Pregnancy Test is intended for non-professional use for the identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy. The test utilizes a combination of monoclonal and polyclonal antibody reagents to selectively detect elevated levels of hCG. The assay is conducted by urinating on the absorbent wick and observing for the formation of colored bands. The specimen migrates via capillary action along the wick and membrane to react with the colored conjugate. Positive specimens react with the specific antibody-hCG-colored conjugate and form a colored band on the Specimen portion of the membrane. Absence of this colored band suggests a negative result. To serve as a procedural control, a colored band at the Control Zone will always appear regardless of the presence or absence of hCG.
The MidStream™ Home Pregnancy test detects hCG concentrations of 25 mIU/ml and greater. The test has been standardized to the World Health Organization Third International Standard. The addition of hLH (500 mIU/ml), hFSH (1000 mIU/ml), and hTSH (1000 µIU/ml) to negative (0 mIU/ml hCG) and positive (25 mIU/ml hCG) urine showed no cross-reactivity.
Clinical trials using MidStream™ were conducted which included 112 female participants. The results of the study showed that the majority of the participants found MidStream™ Home Pregnancy Test very easy to use, and that they had no trouble understanding the labeling, reading the instructions, or interpreting the results.
The comparison study between the participants results and laboratory results indicated an overall agreement of 99.1%. The overall results of the clinical trial confirm that MidStream™ Home Pregnancy Test is a suitable test for over-the-counter pregnancy testing.
Martin O'Connor, Regulatory Affairs
9-30-97
Date
16973825
Premarket Notification 510(k) Number
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around it. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the head, body, and tail feathers.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 19 1997
Martin O'Connor General Manager Germaine Laboratories, Inc. 4203 Gardendale Center Suite 230 78229 San Antonio, Texas
Re : K973825 MidStream™ Home Pregnancy Test Regulatory Class: II Product Code: DHA, LCX September 30, 1997 Dated: Received: October 7, 1997
Dear Mr. O'Connor:
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 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 Requlations, 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 Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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.
{2}------------------------------------------------
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 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
{3}------------------------------------------------
Indications For Use
1973825 510(k) Number:
Device Name: MidStream™ Home Pregnancy Test
"Indications For Use" -
MidStream™ Home Pregnancy Test is intended for nonprofessional use for the identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy.
U. Michell Arnald for AC/Attorney
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K973825
(Please do not write below this point)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109)
Or
Over-The-Counter Use
§ 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.