MIDSTREAM ONESTEP PREGNANCY HOME TEST

K963341 · Syntron Bioresearch, Inc. · LCX · Dec 2, 1996 · Clinical Chemistry

Device Facts

• Record ID: K963341
• Device Name: MIDSTREAM ONESTEP PREGNANCY HOME TEST
• Applicant: Syntron Bioresearch, Inc.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Dec 2, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended 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.

Device Story

Midstream OneStep is an OTC solid-phase immunoassay for qualitative hCG detection in urine. Device utilizes sandwich dye-conjugate technology; gold-sol-antibody conjugate binds to hCG in specimen, forming antibody-antigen complex. Complex binds to anti-hCG antibody in positive reaction zone, producing purple-pink band at hCG concentrations ≥25 mIU/ml. Control line confirms reagent/device function. Used by consumers at home; results interpreted visually by user. Provides rapid pregnancy status confirmation; aids in early pregnancy identification.

Clinical Evidence

Clinical study of 102 female consumers (ages 18-49). Study compared Midstream OneStep results against Besure Plus OneStep and physician clinical diagnosis. Results showed 100% correlation between Midstream OneStep and Besure Plus, and 100% correlation with clinical diagnosis (9 pregnant, 93 non-pregnant).

Technological Characteristics

Solid-phase immunoassay; sandwich dye-conjugate non-enzyme format; gold-sol-antibody conjugate; 25 mIU/ml hCG sensitivity cutoff; lateral flow absorbent device; visual readout.

Indications for Use

Indicated for qualitative detection of hCG in urine for pregnancy determination in females aged 18-49.

Regulatory Classification

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. 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.

Predicate Devices

• Besure Plus OneStep immunoassay

Submission Summary (Full Text)

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K963341
DEC -2 1996

# Summary of Safety and Effectiveness

## 1. Company:

Syntron Bioresearch, Inc.
2774 Loker Avenue West
Carlsbad, CA 92008
Phone: [phone]
Charles Yu

## 2. Date Prepared:

August 18, 1996

*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-sol-antibody 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 |

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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.

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| Patient I.D. | Mulstream OneStep hCG Pregnancy Test | Resist- 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 |

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| 29. | - | - | Non-Pregnant |
| --- | --- | --- | --- |
| Patient I.D. | Midsream OneStep ht G Pregnancy Test | Resure 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 |

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| Patient I/D | Midstream OneStep hCG Pregnancy Test | Resure 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 |

15

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| Patient ID | Midstream OneStep hCG Pregnancy Test | Resure 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 |