(58 days)
Signal™ is a visual and rapid test for the qualitative determination of human chorionic gonadotropin (hCG) in urine to aid in early detection of pregnancy. This test is intended for over-the-counter use.
Signal™ detects the presence of hCG in urine by using a combination of polyclonal and monoclonal antibodies on the reagent pad and the test strip. The assay begins functioning with the addition of urine onto the absorbent wick. Through capillary action the urine is pulled along the membrane to the reagent pad where the hCG reacts with the conjugate. Positive results are determined by two colored lines in the window. The absence of hCG produces only one colored line in the window.
Here's an analysis of the provided information, structured to address your specific points:
The provided text contains limited details regarding the acceptance criteria and the full study methodology. Based on the available summary, here's what can be extracted:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Specificity | >99% acceptance |
| Sensitivity | >99% acceptance |
| Accuracy | >99% acceptance |
| Interfering Substances | >99% acceptance |
| Stability Studies | >99% acceptance |
| Laboratory Comparison Study | >99% accuracy (with SAS™ Pregnancy Strip Test Kits) |
Note: The exact numerical values for specificity, sensitivity, and accuracy are not provided, only that they exceeded "99% acceptance." It's unclear if "acceptance" refers to meeting a pre-defined threshold or simply indicating a high performance.
Study Information
The document describes a "Laboratory Comparison Study" and mentions other performance studies.
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Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: For the "Laboratory Comparison Study," a sample size of 100 test devices was used.
- Data Provenance: Not explicitly stated. Given it's a laboratory comparison study of a diagnostic device, it likely involved collected human urine samples, but no specifics on country of origin or whether it was retrospective or prospective are provided.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. For a pregnancy test, the "ground truth" would typically be established through a reference method (e.g., a laboratory-grade hCG assay with known performance characteristics) or clinical confirmation of pregnancy. The document only mentions comparison against another device (SAS™ Pregnancy Strip Test Kits).
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Adjudication method for the test set:
- This information is not provided in the document. It's unlikely that "adjudication" in the sense of expert review of ambiguous cases would be required for a one-step qualitative pregnancy test unless there were discrepancies between the device and the reference standard that needed resolution.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is a rapid, one-step visual test intended for over-the-counter home use, meaning the "reader" is typically the end-user. As such, there is no AI component or human assistance model relevant to an MRMC study for this device.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Partially applicable. This device is a standalone diagnostic test. Its performance metrics (specificity, sensitivity, accuracy) were assessed for the device itself without explicit human "in-the-loop" assistance. However, it's a visual test, meaning a human always interprets the result (the presence or absence of colored lines). Therefore, the "standalone" performance here refers to the chemical and physical reaction of the device, assuming correct interpretation by the user.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The primary ground truth for the "Laboratory Comparison Study" was another device: SAS™ Pregnancy Strip Test Kits.
- For the "Specificity, Sensitivity & Accuracy" studies, the ground truth would have been established by confirming the presence or absence of hCG in urine samples, likely using a laboratory reference method (e.g., quantitative hCG assay). The document does not specify the exact method for this initial ground truth.
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The sample size for the training set:
- This information is not provided in the document. For non-AI/ML devices like this pregnancy test, there isn't a "training set" in the computational sense. The device's design is based on established biological and chemical principles, and its performance is validated through testing on various samples, not through iterative training.
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How the ground truth for the training set was established:
- As there is no "training set" in the AI/ML context for this device, this question is not applicable. The ground truth for validating the device's performance would be established as described in point 6.
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KY40Ci
510(K) SUMMARY
DEC 1 9 1997
| 510(k) Number: | K974021 |
|---|---|
| Product Name: | Signal™ One-Step Pregnancy Test Kit |
| Submitted by: | SA Scientific, Inc.4919 Golden QuailSan Antonio, TX, 78240 |
| Contact: | Mike CrispPh: (210) 699-8800Fax: (210) 699-6545 |
| Product Name: | Signal™ One-Step Pregnancy Test Kit |
| Classification: | Human chorionic gonadotropin (hCG) test system |
| Intended Use: | Rapid one-step visual test for the qualitative detection ofhCG in human urine to aid in the diagnosis of pregnancy.This test is intended for over-the-counter home use. |
| Description of Device: | Signal™ detects the presence of hCG in urine by using acombination of polyclonal and monoclonal antibodies on thereagent pad and the test strip. The assay begins functioningwith the addition of urine onto the absorbent wick.Through capillary action the urine is pulled along themembrane to the reagent pad where the hCG reacts with theconjugate. Positive results are determined by two coloredlines in the window. The absence of hCG produces onlyone colored line in the window. |
| Substantial Equivalence Device: | Be Sure® Plus Pregnancy Test Kit |
| Clinical Reference Device: | SAS™ Pregnancy Strip |
| Performance Data: | Specificity, Sensitivity & Accuracy, Interfering Substances,and Stability Studies resulted in >99% acceptance. Alaboratory Comparison Study of 100 test devices with SAS™Pregnancy Strip Test Kits resulted in >99% accuracy. |
| Date Originally Prepared: | October 28, 1997 |
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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 a stylized eagle with its wings spread, enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
DEC 1 9 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dr. Harbi Shadfan · President SA Scientific, Inc. 4919 Golden Quail 78240 San Antonio, Texas
K974021 Re : Signal™ Preqnancy Test Kit Regulatory Class: II Product Code: LCX October 21, 1997 Dated: Received: October 22, 1997
Dear Dr. Shadfan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the marice is substantially equivalent (for the indications for use stated in the enclosure) to 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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing 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 regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:
this response to your premarket notification submission does not affect any obligation 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 regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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/dsmamain.html".
Sincerely yours,
Steven Litman
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
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Indications For Use
510(k) Number: K974021
Device Name: Signal™ Pregnancy Test Kit
"Indications For Use" -
Signal™ is a visual and rapid test for the qualitative determination of human chorionic gonadotropin (hCG) in urine to aid in early detection of pregnancy. This test is intended for over-the-counter use.
J.D. Wilbanks for AW. Montgomery
(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
ﮨﮯ Over-The-Counter Use (Optional Format 1-2-96)
§ 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.