(25 days)
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Not Found
No
The summary describes a visual test for hCG detection, which is a standard immunoassay and does not mention any AI/ML components or image processing.
No
The device aids in the early detection of pregnancy, which is a diagnostic purpose, not a therapeutic one. It does not treat or alleviate a medical condition.
Yes
The device is intended to aid in the early detection of pregnancy by detecting hCG, which is a diagnostic purpose.
No
The description clearly states the device is a "visual test" for detecting hCG in serum or urine, which implies a physical test strip or kit, not a software-only device.
Yes, based on the provided information, the SASTM Value hCG device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of human chorionic gonadotropin (hCG) in serum or urine." This involves testing biological samples in vitro (outside the body).
- Purpose: The purpose is "to aid in the early detection of pregnancy," which is a diagnostic purpose.
- Sample Type: It uses "serum or urine," which are biological specimens.
These characteristics are defining features of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
SASTM Value hCG is a visual test for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine.to aid in the early detection of pregnancy. The test is for professional use.
Product codes
JHI
Device Description
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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
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)
Not Found
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
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design of an abstract human figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
8 2002 MAR
Mr. Ricardo Martinez Regulatory Affairs SA Scientific, Inc. 4919 Golden Quial San Antonio, Texas 78240
K020438 Re: Trade/Device Name: SASTM Value hCG Regulation Name: 21 CFR 862. 1155 Regulatory Class: Class II Product Code: JHI Dated: February 1, 2002 Received: February 11, 2002
Dear Mr. Martinez:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for association 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, ato.erovisions 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594 your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Steven Autman
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
2
INDICATIONS FOR USE
SA Scientific, Inc. Applicant: 4919 Golden Quail San Antonio, TX. 78240 Ph: (210) 699-8800 Fax: (210) 6996545
Establishment Reg. No .: 1645225
501(k) Number: K020438
Device Name:
SAS™ Value hCG
Indications for Use:
SASTM Value hCG is a visual test for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine.to aid in the early detection of pregnancy.
The test is for professional use.
(Please do not write below this line)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
FR 801.109)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K020438
Prescription Use
or
Over-the-Counter