(73 days)
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No
The device description details a lateral flow immunoassay that relies on chemical reactions and visual interpretation of colored bands, with no mention of computational analysis or algorithms.
No
The device aids in the determination of pregnancy by identifying hCG, which is a diagnostic function, not a therapeutic one. It does not treat or cure any condition.
Yes
The device is described as aiding in the determination of pregnancy by identifying hCG in urine, which is a diagnostic purpose to identify a medical condition.
No
The device description clearly outlines a physical test strip that uses chemical reactions and capillary action to detect hCG in urine, indicating it is a hardware-based diagnostic device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy." This involves testing a biological sample (urine) in vitro (outside the body) to diagnose a condition (pregnancy).
- Device Description: The description details how the test works by reacting with a biological sample (urine) using chemical reagents (monoclonal and polyclonal antibodies) to detect a specific analyte (hCG). This is a hallmark of an in vitro diagnostic test.
- Nonprofessional Use: While it's intended for nonprofessional use, this doesn't preclude it from being an IVD. Many home-use tests are IVDs.
The definition of an IVD generally includes devices intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly fits that description.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DHA, LCX
Device Description
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.
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
non-professional 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
Clinical trials using MidStream™ were conducted which included 112 female participants.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
overall agreement of 99.1%
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.
Not Found
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
"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.
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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.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