(58 days)
Not Found
SAS™ Pregnancy Strip
No
The device description details a chemical reaction using antibodies and capillary action to produce a visual result (colored lines). There is no mention of any computational analysis, image processing, or algorithms that would suggest the use of AI or ML. The performance studies focus on the accuracy of the chemical detection.
No.
The device is for the qualitative determination of human chorionic gonadotropin in urine to aid in early detection of pregnancy, making it a diagnostic device rather than a therapeutic one.
Yes
This device is a diagnostic device because it qualitatively determines the presence of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy, which is a medical condition. It provides information to diagnose pregnancy.
No
The device description clearly outlines a physical test strip with reagent pads and antibodies that react with urine, indicating a hardware component is essential for its function.
Yes, based on the provided information, the Signal™ device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "qualitative determination of human chorionic gonadotropin (hCG) in urine to aid in early detection of pregnancy." This involves testing a biological sample (urine) outside of the body to diagnose or aid in the diagnosis of a condition (pregnancy).
- Device Description: The description details how the device works by detecting a specific analyte (hCG) in a biological sample (urine) using antibodies and a chemical reaction to produce a visual result. This is characteristic of an in vitro diagnostic test.
- Over-the-counter use: While it's for over-the-counter use, this doesn't preclude it from being an IVD. Many home-use tests are IVDs.
The definition of an IVD generally involves devices intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Signal™ device fits this description perfectly.
N/A
Intended Use / Indications for Use
Rapid one-step visual test for the qualitative detection of hCG in human urine to aid in the diagnosis of pregnancy. This test is intended for over-the-counter home use.
Product codes (comma separated list FDA assigned to the subject device)
LCX
Device Description
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.
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 home 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Specificity, Sensitivity & Accuracy, Interfering Substances, and Stability Studies resulted in >99% acceptance. A laboratory Comparison Study of 100 test devices with SASTM Pregnancy Strip Test Kits resulted in >99% accuracy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
99% acceptance, >99% accuracy
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.
Be Sure® Plus Pregnancy Test Kit
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.
SAS™ Pregnancy Strip
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).
Not Found
§ 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
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 Quail | |
| San Antonio, TX, 78240 | |
| Contact: | Mike Crisp |
| Ph: (210) 699-8800 | |
| Fax: (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 of |
| hCG 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 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. | |
| 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. A | |
| laboratory Comparison Study of 100 test devices with SAS™ | |
| Pregnancy Strip Test Kits resulted in >99% accuracy. | |
| Date Originally Prepared: | October 28, 1997 |
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 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
3
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)