(31 days)
EZESure™ (Excel) Urine Midstream Early Pregnancy Home Test is Excel Scientific, Inc.'s device for OTC use of EZ Sure™ (Excel) Urine Midstream Early Pregnancy Home Test for the qualitative detection of human chorionic gonadotropin (hCG) in urine.
The EZ Sure™ (Excel) Urine Midstream Pregnancy Home Test is a sandwich solid phase dye-conjugate non-enzyme immunoassay. The stream of urine goes directly into the absorbent windows of the reaction device. The labeled antibody dye-conjugate binds to the hCG in the specimen forming an antibody-antigen complex. This complex binds to the antibody in the positive reaction zone and produces a rose-pink color band when hCG concentration is equal to or greater than 25 mIU/mL. In the absence of hCG, there is no line formation in the positive reaction zone. The reaction mixture continues to flow through the device and migrates to the control reaction zone by producing a rose-pink color band, demonstrating that the reagents and device are functioning correctly.
Here's a breakdown of the acceptance criteria and study information for the EZESure™ (Excel) Urine Midstream Early Pregnancy Home Test, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Agreement with predicate device (Syntron Quikpac II/BeSure Home Test) | > 99% agreement with Syntron Quikpac II (BeSure Home Test) |
| Sensitivity (Cutoff) | 25 mIU/mL |
| Simplicity of Use | Simple to perform (from consumer comments) |
| Speed of Results | Fast (from consumer comments) |
| Correct Functionality (Control Line) | Rose-pink color band in control zone demonstrates correct functioning |
Note: The document only explicitly states "greater than 99% in agreement" with the predicate device as an acceptance criterion being met. Other criteria like sensitivity, simplicity, and speed are mentioned as characteristics of the device and supported by consumer comments implicitly indicating acceptable performance.
2. Sample Size and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It only mentions "comparative data with Syntron Quikpac II pregnancy test (BeSure Home Test)."
3. Number of Experts and Qualifications
The document does not mention the number of experts used to establish ground truth or their qualifications.
4. Adjudication Method
The document does not mention an adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The study described is a comparison of the EZESure™ device's performance against a predicate device (Syntron Quikpac II/BeSure Home Test), not a study involving human readers with and without AI assistance to measure improvement.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone study comparing the EZESure™ device to a predicate device's performance was done, indicating "greater than 99% in agreement." This refers to the performance of the EZESure™ device on its own, relative to an established test.
7. Type of Ground Truth Used
The ground truth for the comparison was established by the performance of the predicate device, the Syntron Quikpac II (BeSure Home Test). The document states the EZESure™'s performance is based on "comparative data with Syntron Quikpac II pregnancy test (BeSure Home Test)." This implies that the results from the BeSure Home Test were considered the reference or "ground truth" against which the EZESure™ device was evaluated. The underlying gold standard for both tests is the detection of human chorionic gonadotropin (hCG).
8. Sample Size for the Training Set
The document does not specify a separate training set or its sample size. The description of the device's mechanism (sandwich solid phase dye-conjugate immunoassay) and the comparison study suggest a validation or performance evaluation approach rather than a machine learning "training set" in the typical sense.
9. How Ground Truth for Training Set Was Established
Since there is no mention of a separate training set for a machine learning algorithm, the concept of establishing ground truth for a training set in this context is not applicable. The device's performance and "agreement" are based on its ability to detect hCG at a specific cutoff, validated against an existing, marketed test.
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Attachment #5
Summary of Safety and Effectiveness
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The Pnnciple of EZ $ Sure™ (Excel) Urine Midstroam Early Pregnancy Home Test is as fallows:
- The EZ Sure™ (Excel) Urine Midstream Prognancy Horne Test also is a sendwich solid phase dye-1. r ning at d non-enzyme immunossay. The stream of unine goes directly into the absorbent windows of the reaction device. The laboled antibody dye-conjugate binds to the hCG in the specimen forming an antibody-antigen complex. This complex binds to the antibudy in the positive reaction zone and arnatuce a rose-pink color band when hCG concentration is equal to or greater than 25 mlUmL. In the abseries of hCG, there is no line formation in the positive reaction mixture continues lu flow through the device and migrates to the control reaction zone by producing a rose-pink color band, demonstrating that the reagents and device are functioning corroctly.
- The Quikpec II (or BeSure Home Test) also is a sono phase sandwich dye-wrijugale non-enzymo 2. immunossay As the specimen is added to the reaction device, the lebelod antibody dye conjugate binds to the hCG in the specimen forming an antibody-antigen complex. This complex binds to the anti-RCG antibody in the positive reaction zone and produces a rose-pink color band when hCG currentration is equal to or greater than 25 mILV/mL in the specimen. In the absence of hCG, there is no line formation in the positive reaction zone. The reaction mixture continues to flow through the device and migrates into the control roaction zone by producing a rose-pink rator band control, demonstrating that the reagents and device are functioning correctly.
- 3 The exact difforences between the EZRSure™ (Excel) Urine Midstream Early Programcy Home Tust protocol and the Syntron's Quikpac II pregnancy test (BeSure Horne Test) protocol are as follows :
| Quikpac II pregnancy test(BeSure Home Test) | EZ Sure™ (Excel) UrineMidstream EarlyPregnancy Home Test | |
|---|---|---|
| Specimen Volume | 6 drops | Urine stream |
| Incubation | 5 minutes | 5 minutes |
| Reagent | No | No |
| Step | one step | one step |
| Cutoff | 25 mIU/mL | 25 mIU/mL |
| Urine Cup | Yes | No |
- 4 The EZY Sure™ (Excel) Urine Midstream Early Prognancy Home Tosts has been found to be greater than 99% in agreement with and the Syntron Quiliped II test) that is currently available commercially. Comments from consumers also support that the test is simple to perform and the results are fast.
- ה For questions conceming the safety and effectiveness of the EZ9 Sure™ Urine Midstream Early Pregnancy Home Test, please contact:
Min-Lee Cheng, Ph.D. 23071 E. La Palma Avenue Yorba Linda, CA 82887 Tel: (714) 682-7151
25071 E. La Polma Avo, Yorka Linda, CA 82687, U.S.A Tol: (714) 802-7151 Pax: (714) 802-7155
§ 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.