(98 days)
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No
The device description details a standard immunoassay based on chemical reactions and color changes, with no mention of AI or ML technologies. The performance studies focus on comparing the device's results to a predicate device and clinical diagnosis, not on evaluating an AI/ML algorithm.
No.
This device is an in vitro diagnostic test for the qualitative determination of human Chorionic Gonadotropin (hCG) in urine, indicating pregnancy, rather than providing therapy or treatment.
Yes
Explanation: The device is an "in vitro diagnostic test kit" used for the "qualitative determination of human Chorionic Gonadotropin (hCG) in urine," which is a diagnostic purpose. It determines a medical condition (pregnancy).
No
The device description clearly indicates it is a "solid phase immunoassay in vitro diagnostic test kit" and a "sandwich solid phase dye-conjugate non-enzyme immunoassay," which are hardware-based tests involving physical components and chemical reactions.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"Midstream OneStep pregnancy test is Syntron Bioresearch, Inc. name for OTC use of solid phase immunoassay in vitro diagnostic test kit for the qualitative determination of human Chorionic Gonadotropin (hCG) in urine."
This statement clearly identifies the device as an in vitro diagnostic test kit.
N/A
Intended Use / Indications for Use
Midstream OneStep pregnancy test is Syntron Bioresearch, Inc. name for OTC use of solid phase immunoassay in vitro diagnostic test kit for the qualitative determination of human Chorionic Gonadotropin (hCG) in urine.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Midstream and Besure Plus pregnancy test is a sandwich solid phase dye-conjugate non-enzyme immunoassay. As the specimen is added to the reaction device, the gold-solantibody conjugate binds to the hCG in the specimen forming an antibody-antigen complex. This complex binds to the anti-hCG antibody in the positive reaction zone and produces a purple-pink color band when hCG concentration is equal or greater than 25 mIU/ml. In the absence of hCG, there is no purple-pink line in the positive reaction zone. The reaction mixture continues to flow through the absorbent device, pass the positive reaction zone, producing a purple-pink color band, demonstrating that the reagents and device are functioning correctly.
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
OTC 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
The Midstream OneStep Pregnancy Home Test was performed by 102 consumers: females selected between the ages of 18 and 49 years old, pregnant and non-pregnant, were told to use midstream test and BeSure Plus pregnancy test and compare both results obtained. Confirmation of clinical status was also based on the clinical diagnosis submitted by physician.
Of the 102 samples tested. 93 had a confirmed clinical diagnosis of non-pregnancy and 9 had a diagnosis of pregnancy.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A home use study was conducted with 102 consumers (females aged 18-49, pregnant and non-pregnant). Participants used both the Midstream OneStep pregnancy test and the Besure Plus pregnancy test. Clinical diagnoses were obtained from physicians.
Results showed 100% correlation between the Midstream pregnancy test and Syntron's Besure Plus OneStep hCG test, and 100% correlation between the Midstream test and clinical diagnosis.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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
DEC – 2 – 2 (996
Summary of Safety and Effectiveness
1. Company:
Syntron Bioresearch, Inc. 2774 Loker Avenue West Carlsbad, CA 92008 Phone: 619.930.2200 Charles Yu August 18, 1996
2. Date Prepared:
Midstream OneStep pregnancy test is Syntron Bioresearch, Inc. name for OTC use of solid phase immunoassay in vitro diagnostic test kit for the qualitative determination of human Chorionic Gonadotropin (hCG) in urine. Midstream OneStep pregnancy test is based on comparative data with Besure Plus OneStep immunoassay, an assay for human Chorionic Gonadotropin currently being marketed.
The Principle of Midstream and Besure Plus Pregnancy Test is as follows:
The Midstream and Besure Plus pregnancy test is a sandwich solid phase dye-conjugate non-enzyme immunoassay. As the specimen is added to the reaction device, the gold-solantibody conjugate binds to the hCG in the specimen forming an antibody-antigen complex. This complex binds to the anti-hCG antibody in the positive reaction zone and produces a purple-pink color band when hCG concentration is equal or greater than 25 mIU/ml. In the absence of hCG, there is no purple-pink line in the positive reaction zone. The reaction mixture continues to flow through the absorbent device, pass the positive reaction zone, producing a purple-pink color band, demonstrating that the reagents and device are functioning correctly.
The Two Protocols Are
| | Besure Plus OneStep
Pregnancy Test | Midstream OneStep
Pregnancy Test |
|------------|---------------------------------------|-------------------------------------|
| Incubation | 5minutes | 5minutes |
| Reagent | No | No |
| Step | 1 Step | 1 Step |
| Cutoff | 25 mIU/ml | 25 mIU/ml |
| Urine Cup | No | No |
1
The Midstream OneStep Pregnancy Home Test was performed by 102 consumers: females selected between the ages of 18 and 49 years old, pregnant and non-pregnant, were told to use midstream test and BeSure Plus pregnancy test and compare both results obtained. Confirmation of clinical status was also based on the clinical diagnosis submitted by physician.
Of the 102 samples tested. 93 had a confirmed clinical diagnosis of non-pregnancy and 9 had a diagnosis of pregnancy. Test results obtained by the consumers showed a 100% correlation between midstream pregnancy test with Syntron's Besure Plus OneStep hCG test. Physician report also indicated a 100% correlation between midstream test and clinical diagnosis.
A survey was conducted on the consumers' educational background who had participated in our pregnancy studies. Of the 102 consumers, approximately 8% of the people have bachelor degrees. 75% of the consumers have high school education and various training in vocational schools. The remaining 17% of the consumers have only junior high school education.
The results form also indicated consumer remarks on the performance of the midstream test. Their remarks are:
- A. Two test are virtually the same.
- B. Quick & easy.
- C. Simple test.
- D. Easy to use.
- E. Clear signal.
- F. Good test.
2
| Patient
I.D. | Midstream OneStep
hCG Pregnancy Test | Besure Plus
Pregnancy Test | Clinical Diagnosis |
|-----------------|-----------------------------------------|-------------------------------|--------------------|
| 1. | - | - | Non-Pregnant |
| 2. | - | - | Non-Pregnant |
| 3. | - | - | Non-Pregnant |
| 4. | - | - | Non-Pregnant |
| 5. | - | - | Non-Pregnant |
| 6. | - | - | Non-Pregnant |
| 7. | - | - | Non-Pregnant |
| 8. | - | - | Non-Pregnant |
| 9. | + | + | Pregnant |
| 10. | - | - | Non-Pregnant |
| 11. | - | - | Non-Pregnant |
| 12. | - | - | Non-Pregnant |
| 13. | - | - | Non-Pregnant |
| 14. | - | - | Non-Pregnant |
| 15. | + | + | Pregnant |
| 16. | - | - | Non-Pregnant |
| 17. | - | - | Non-Pregnant |
| 18. | - | - | Non-Pregnant |
| 19. | - | - | Non-Pregnant |
| 20. | - | - | Non-Pregnant |
| 21. | - | - | Non-Pregnant |
| 22. | - | - | Non-Pregnant |
| 23. | + | + | Pregnant |
| 24. | - | - | Non-Pregnant |
| 25. | - | - | Non-Pregnant |
| 26. | - | - | Non-Pregnant |
| 27. | - | - | Non-Pregnant |
| 28. | - | - | Non-Pregnant |
| 29. | | | Non-Pregnant |
| Patient
I.D. | Midstream OneStep
hCG Pregnancy Test | Besure Plus
Pregnancy Test | Clinical Diagnosis |
| 30. | - | - | Non-Pregnant |
| 31. | - | - | Non-Pregnant |
| 32. | - | - | Non-Pregnant |
| 33. | - | - | Non-Pregnant |
| 34. | - | - | Non-Pregnant |
| 35. | - | - | Non-Pregnant |
| 36. | - | - | Non-Pregnant |
| 37. | - | - | Non-Pregnant |
| 38. | - | - | Non-Pregnant |
| 39. | - | - | Non-Pregnant |
| 40. | - | - | Non-Pregnant |
| 41. | - | - | Non-Pregnant |
| 42. | - | - | Non-Pregnant |
| 43. | - | - | Non-Pregnant |
| 44. | - | - | Non-Pregnant |
| 45. | - | - | Non-Pregnant |
| 46. | - | - | Non-Pregnant |
| 47. | - | - | Non-Pregnant |
| 48. | - | - | Non-Pregnant |
| 49. | - | - | Non-Pregnant |
| 50. | - | - | Non-Pregnant |
| 51. | - | - | Non-Pregnant |
| 52. | - | - | Non-Pregnant |
| 53. | - | - | Non-Pregnant |
| 54. | - | - | Non-Pregnant |
| 55. | - | - | Non-Pregnant |
| 56. | - | - | Non-Pregnant |
| 57. | - | - | Non-Pregnant |
| 58. | - | - | Non-Pregnant |
| Patient
I.D. | Midstream OneStep
hCG Pregnancy Test | Besure Plus
Pregnancy Test | Clinical Diagnosis |
| 59. | + | + | Pregnant |
| 60. | - | - | Non-Pregnant |
| 61. | - | - | Non-Pregnant |
| 62. | - | - | Non-Pregnant |
| 63. | - | - | Non-Pregnant |
| 64. | + | + | Pregnant |
| 65. | - | - | Non-Pregnant |
| 66. | - | - | Non-Pregnant |
| 67. | - | - | Non-Pregnant |
| 68. | - | - | Non-Pregnant |
| 69. | - | - | Non-Pregnant |
| 70. | - | - | Non-Pregnant |
| 71. | - | - | Non-Pregnant |
| 72. | - | - | Non-Pregnant |
| 73. | - | - | Non-Pregnant |
| 74. | - | - | Non-Pregnant |
| 75. | - | - | Non-Pregnant |
| 76. | - | - | Non-Pregnant |
| 77. | - | - | Non-Pregnant |
| 78. | - | - | Non-Pregnant |
| 79. | - | - | Non-Pregnant |
| 80. | - | - | Non-Pregnant |
| 81. | - | - | Non-Pregnant |
| 82. | - | - | Non-Pregnant |
| 83. | - | - | Non-Pregnant |
| 84. | - | - | Non-Pregnant |
| 85. | - | - | Non-Pregnant |
| 86. | - | - | Non-Pregnant |
| 87. | - | - | Non-Pregnant |
| Patient I.D. | Midstream OneStep
hCG Pregnancy Test | Besure Plus
Pregnancy Test | Clinical Diagnosis |
| 88. | - | - | Non-Pregnant |
| 89. | - | - | Non-Pregnant |
| 90. | - | - | Non-Pregnant |
| 91. | - | - | Non-Pregnant |
| 92. | - | - | Non-Pregnant |
| 93. | - | - | Non-Pregnant |
| 94. | + | + | Pregnant |
| 95. | - | - | Non-Pregnant |
| 96. | + | + | Pregnant |
| 97. | - | - | Non-Pregnant |
| 98. | - | - | Non-Pregnant |
| 99. | - | - | Non-Pregnant |
| 100. | - | - | Non-Pregnant |
| 101. | - | - | Non-Pregnant |
| 102. | - | - | Non-Pregnant |
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