(97 days)
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No
The device description and intended use clearly indicate a qualitative immunoassay for detecting LH in urine, with no mention of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No.
This device is an ovulation predictor, which helps in family planning by detecting LH surges. It does not treat, diagnose, mitigate, or prevent diseases or conditions.
Yes
Explanation: The device is an immunoassay that detects Luteinizing Hormone (hLH) in urine to predict ovulation, which is a physiological state. Diagnosing a physiological state or condition falls under the definition of a diagnostic device.
No
The device description clearly states it is a "monoclonal antibody-based immunoassay" and a "qualitative visual test system for the detection of human Luteinizing Hormone (hLH) in urine," indicating it is a physical test kit, not software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "visual qualitative detection of human Luteinizing Hormone (hLH) in urine." This involves testing a sample taken from the human body (urine) in vitro (outside the body) to provide information about a physiological state (ovulation).
- Device Description: The description reinforces that it's a "qualitative visual test system for the detection of human Luteinizing Hormone (hLH) in urine."
- Nature of the Test: Immunoassays, like the one described, are a common type of IVD test.
The fact that it's intended for home use and is similar to other over-the-counter products further supports its classification as an IVD, specifically a consumer-use IVD.
N/A
Intended Use / Indications for Use
The MiniClinic Ovulation Predictor is a monoclonal antibody-based immunoassay intended for the visual qualitative detection of human Luteinizing Hormone (hLH) in urine. This test is used to detect the mid-cycle LH surge which occurs approximately 24 hours prior to ovulation. By predicting ovulation, conception can be planned most effectively. Its intended use is identical to that of several over-the-counter (OTC) products currently available for home use.
Product codes
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Device Description
The MiniClinic Ovulation Predictor is a qualitative visual test system for the detection of human Luteinizing Hormone (hLH) in urine as an indicator of ovulation and would be classified as a Human Luteinizing Hormone Test System.
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
consumer use / 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
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Key Metrics
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Predicate Device(s)
Conceive ® Ovulation Predictor, Clearplan Easy One Step Ovulation Predictor
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1485 Luteinizing hormone test system.
(a)
Identification. A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
0
K96023
Image /page/0/Picture/1 description: The image shows the logo for Vanguard Biomedical Corporation. The logo consists of a geometric shape resembling three nested triangles on the left. To the right of the shape is the word "VANGUARD" in large, bold letters, with the words "BIOMEDICAL CORPORATION" in smaller letters underneath.
10225 BARNES CANYON ROAD, SUITE A108
SAN DIEGO, CALIFORNIA 92121 USA
TEL: (619) 554-1361 FAX: (619) 554-1362
K960233
APR 23 1996
MiniClinic Ovulation Predictor for Consumer Use
510(k) Summary of Product Safety and Effectiveness
The trade name of this device is MiniClinic Ovulation Predictor. It is a qualitative visual test system for the detection of human Luteinizing Hormone (hLH) in urine as an indicator of ovulation and would be classified as a Human Luteinizing Hormone Test System.
Vanguard Biomedical Corporation considers the MiniClinic Ovulation Predictor to be substantially equivalent to other comparable FDA-approved products in intended use, test procedure, and test principles.
INTENDED USE
The MiniClinic Ovulation Predictor is a monoclonal antibody-based immunoassay intended for the visual qualitative detection of human Luteinizing Hormone (hLH) in urine. This test is used to detect the mid-cycle LH surge which occurs approximately 24 hours prior to ovulation. By predicting ovulation, conception can be planned most effectively. Its intended use is identical to that of several over-the-counter (OTC) products currently available for home use.
These include: Conceive ® Ovulation Predictor Quidel 10165 McKellar Court San Diego, CA 92121 Whitehall Labs, Inc. Clearplan Easy One Step Ovulation Predictor New York, N.Y.
PRINCIPLES AND PROCEDURES
The urine sample is applied to a paper reservoir which is in contact with a pad containing a dried conjugate of colloid gold-monoclonal antibody (reddish in color). The urine sample will then reconstitute the dried conjugate. If hLH is present in the sample, it will react with the monoclonal antibody to form a complex of colloid gold-monoclonal antibody-hLH. This complex migrates up in a membrane strip chromatographically and through a band of immobilized goat anti-hI.H( the test line). Because the antibody of this immobilized goat anti-hIH is able to bind the hLH molecule of the migrating complex, a visible reddish band is formed along the exact location of the immobilized goat anti-hLH antibody. The amount of color seen on the test line is proportional to the amount of hLH present in the urine sample.
Further up the membrane, past the anti-hLH test line, is a control line consisting of a band of immobilized goat anti-mouse IgG. This band of antibody will bind only conjugate and form a colored line, regardless of whether hLH is present in the urine or not. The concentration of good anti-mouse lgG and colloid conjugate are adjusted to give a color response against
which the test line can be compared. Levels of hill above baseline values will produce colo
Contact: John Chiu, Ph.D. Director, Research & Development Prepared: January 8, 1996