(75 days)
K871602/A
No
The device description and performance studies describe a standard immunoassay test kit that relies on chemical reactions and visual interpretation of color bands, with no mention of AI or ML technologies.
No.
This device is an in vitro diagnostic test for determining when ovulation will occur, not a therapeutic device designed to treat or alleviate a condition.
Yes
The Intended Use section clearly states that the device is "an in vitro diagnostic test kit" and is used for the "qualitative determination of leutinizing hormone (LH) in urine" to "determine when the female body will ovulate," which is a diagnostic purpose.
No
The device description clearly states it is a "solid phase immunoassay in vitro diagnostic test kit" and describes a physical test strip with chemical reactions and color bands, indicating it is a hardware-based device.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states in the "Intended Use / Indications for Use" section:
"BeSure Plus OneStep Ovulation Home predicator test is a solid phase immunoassay in vitro diagnostic test kit."
And again in the "Device Description" section:
"BeSure Plus OneStep Ovulation Prediction test is a Syntron Bioresearch, Inc. name for OTC use of solid phase immunoassay in vitro diagnostic test kit for the qualitative determination of Luteinizing Hormone (LH) in urine."
These statements clearly identify the device as an in vitro diagnostic test kit.
N/A
Intended Use / Indications for Use
BeSure Plus OneStep Ovulation Home predicator test is a solid phase immunoassay in vitro diagnostic test kit. It is intended for over the counter use for the qualitative determination of leutinizing hormone (LH) in urine. This test kit is utilized to determine when the female body will ovulate, the most likely time for conception to occur.
Product codes
CEP
Device Description
BeSure Plus OneStep Ovulation Prediction test is a Syntron Bioresearch, Inc. name for OTC use of solid phase immunoassay in vitro diagnostic test kit for the qualitative determination of Luteinizing Hormone (LH) in urine. BeSure Plus OneStep Ovulation Prediction test is based on comparative data with BeSure OneStep Ovulation Predictor test, a qualitative test for the determination of Luteinizing hormone currently being marketed by Syntron Bioresearch, Inc.
The BeSure Plus OneStep Ovulation Prediction Test is a sandwich solid phase dye-conjugate non-enzyme immunoassay. As the urine specimen is added to the reaction device, the gold-sol-anti-B LH antibody conjugate binds to the LH that exists in the urine specimen forming an antibody-antigen complex. This complex then migrates to the positive reaction zone and a LH antibody that is immobilized there by forming an antibody-antibody dye conjugate sandwich, which produces a rose-pink color band. In the absence of LH, there is no rose-pink color band that appears in the positive reaction zone. The remaining dye continues to flow up the absorbent device by passing through the positive reaction zone. This produces a rose-pink color band in the control reaction zone as immobilized antibody captures the unbound dye conjugate, demonstrating that the reagents and device are functioning correctly.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Test results obtained by 100 consumers using BeSure Plus OneStep Ovulation home test. The results were further confirmed by having the laboratory technicians assay the patient's urine to determine the amount of LH for every testing day by using Syntron's Quantitative LH EIA test (K871602/A). In this study, the laboratory technicians did not know the outcome of the consumer's test results.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Test results obtained by 100 consumers using BeSure Plus OneStep Ovulation home test showed a 99% correlation with results independently obtained by laboratory technicians using other commercially available onestep ovulation test. The results were further confirmed by having the laboratory technicians assay the patient's urine to determine the amount of LH for every testing day by using Syntron's Quantitative LH EIA test (K871602/A). The data obtained from the LH EIA test (Syntron) indicated that LH concentration equal or greater than 30 mIU/ml exhibits LH concentration less than 30 mIU/ml exhibits no surge in BeSure Plus OneStep ovulation test, which is comparable to other commercially available onestep ovulation test kit (K951538). These results show that nontechnical users of BeSure Plus OneStep home Ovulation Predictor Kits are able to detect the onset of the LH surge with precision comparable to that obtained by a reference immunoassay performed by trained laboratory technicians.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
99% correlation
Predicate Device(s)
Reference Device(s)
K871602/A
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
K9831/3
Attachment 9
Summary of Safety and Effectiveness
BeSure Plus OneStep Ovulation Prediction test is a Syntron Bioresearch, Inc. name for OTC use of solid phase immunoassay in vitro diagnostic test kit for the qualitative determination of Luteinizing Hormone (LH) in urine. BeSure Plus OneStep Ovulation Prediction test is based on comparative data with BeSure OneStep Ovulation Predictor test, a qualitative test for the determination of Luteinizing hormone currently being marketed by Syntron Bioresearch, Inc.
The BeSure Plus OneStep Ovulation Prediction Test is a sandwich solid phase dye-conjugate non-enzyme immunoassay. As the urine specimen is added to the reaction device, the gold-sol-anti-B LH antibody conjugate binds to the LH that exists in the urine specimen forming an antibody-antigen complex. This complex then migrates to the positive reaction zone and a LH antibody that is immobilized there by forming an antibody-antibody dye conjugate sandwich, which produces a rose-pink color band. In the absence of LH, there is no rose-pink color band that appears in the positive reaction zone. The remaining dye continues to flow up the absorbent device by passing through the positive reaction zone. This produces a rose-pink color band in the control reaction zone as immobilized antibody captures the unbound dye conjugate, demonstrating that the reagents and device are functioning correctly. This working principle can also be applied for the BeSure OneStep Ovulation Prediction test.
| The exact differences in reagent between the two protocols are as follows: | ||
|---|---|---|
| BeSure Plus OneStep | ||
| Ovulation Predictor Test | BeSure OneStep | |
| Ovulation Predictor Test | ||
| (K951538) | ||
| Specimen Volume | Midstream | 4 drops of urine |
| Reagent | No Reagent | No Reagent |
| Incubation | 5 minutes | 5 minutes |
| Steps | 1 Step | 1 Step |
| Surge Cutoff | ≥ 30 mIU/ml | ≥ 30 mIU/ml |
Test results obtained by 100 consumers using BeSure Plus OneStep Ovulation home test showed a 99% correlation with results independently obtained by laboratory technicians using other commercially available onestep ovulation test. The results were further confirmed by having the laboratory technicians assay the patient's urine to determine the amount of LH for every testing day by using Syntron's Quantitative LH EIA test (K871602/A). The data obtained from the LH EIA test (Syntron) indicated that LH concentration equal or greater than 30 mIU/ml exhibits LH concentration less than 30 mIU/ml exhibits no surge in BeSure Plus OneStep ovulation test, which is comparable to other commercially available onestep ovulation test kit (K951538). In this study, the laboratory technicians did not know the outcome of the consumer's test results.
These results show that nontechnical users of BeSure Plus OneStep home Ovulation Predictor Kits are able to detect the onset of the LH surge with precision comparable to that obtained by a reference immunoassay performed by trained laboratory technicians. Copies of consumer's reports are attached at the end of this report. The contact person for this Summary of Safety and Effectiveness report is provided by:
Charles Yu Syntron Bioresearch, Inc. 2774 Loker Avenue West Carlsbad, CA 92008 Tel: 760-930-2200 Fax: 760-930-2212
1
Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized human figure embracing the world. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol. The overall design is simple and professional, reflecting the department's role in public health and human services.
NOV 1 8 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Charles Yu General Manager Syntron Bioresearch, Inc. 2774 Loker Avenue West Carlsbad, California 92008
K983113 Re : BeSure Plus OneStep Home Ovulation Predictor Trade Name: Test Kit Requlatory Class: I Product Code: CEP Dated: August 26, 1998 Received: September 4, 1998
Dear Mr. Yu:
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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturinq 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 requlatory 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 obliqation 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 requlations.
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Page 2
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 Sutman
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
3
Page
510(k) Number (if known): K983113
Device Name: BeSure Plus OneStep home Ovulation Predictor Test Kit.
Indication For Use:
am OneStep Ovulation Home predicator test is a solid phase immunoassay in vitro diagnostic test kit. It is intended for over the counter use for the qualitative determination of leutinizing hormone (LH) in urine. This test kit is utilized to determine when the female body will ovulate, the most likely time for conception to occur.
(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)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K983113