(11 days)
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No
The summary describes urine controls for pregnancy test kits, which are passive reagents and do not involve AI/ML technology.
No
The device is a control for monitoring the performance and accuracy of pregnancy test kits, not for treating any medical condition.
No
Explanation: The device, SASTM hCG Urine Controls, is intended to monitor the performance and accuracy of pregnancy test kits. It is a control material, not a device that directly diagnoses a medical condition or processes patient data for diagnostic purposes.
No
The device is described as "SASTM hCG Urine Controls," which are physical controls used to monitor the performance of pregnancy test kits. This indicates a physical product, not software.
Based on the provided information, the SASTM hCG Urine Controls are an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states they are used to "monitor the performance and accuracy of SASTM pregnancy test kits." This indicates they are used in vitro (outside the body) to assess the function of another diagnostic device.
- Nature of the Device: Controls for diagnostic tests are a common type of IVD. They are used to ensure the test is working correctly and providing reliable results.
While the "Device Description" is not found, the "Intended Use" is the primary indicator of whether a device is an IVD. The fact that it's used to monitor the performance of a pregnancy test kit (which is also an IVD) further supports this classification.
N/A
Intended Use / Indications for Use
SASTM hCG Urine Controls are intended to be used to monitor the performance and accuracy of SASTM pregnancy test kits. These controls are for professional use only.
Product codes
JJX
Device Description
SASTM hCG Urine Controls
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
Professional use only.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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Image /page/0/Picture/2 description: The image shows a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The eagle is depicted in a minimalist style, with simple lines forming its head, body, and wings. The overall design is clean and professional, reflecting the organization's role in public health and human services.
MAR 1 9 1999
Harbi A. Shadfan, Ph.D. President SA Scientific, Inc. 4919 Golden Quail San Antonio, Texas 78240
Re: K990755 Trade Name: SASTM hCG Urine Controls Regulatory Class: I Product Code: JJX Dated: March 5, 1999 Received: March 8, 1999
Dear Dr.Shadfan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 of the Act. The general controls provisions 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 regulations 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 action. In addition, FDA may publish further announcements 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.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
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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/cdrl/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
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
pplicant:
SA Scientific, Inc. 4919 Golden Quail San Antonio, TX 78240 Ph: (210) 699-8800 Fax: (210) 699-6545
Establishment Reg. No .: 1645225
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: SASTM hCG Urine Controls
Indication For Use:
idication For Use: SASTM hCG Urine Controls are intended to be used to monitor the performance and accuracy of SASTM pregnancy test kits. These controls are for professional use only.
tt di M ార్ 22 (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number_K 990755
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Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109) - 1 - 1 -
Prescription Use
Over-the-Counter
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