(126 days)
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No
The summary describes a rapid, visual immunoassay test for hCG, with no mention of AI, ML, image processing, or any computational analysis of data.
No
The device is a diagnostic test (early detection of pregnancy) and not intended for treatment or therapy.
Yes
This device is a diagnostic device because its intended use is to "aid in the early detection of pregnancy" by determining the presence of human chorionic gonadotropin (hCG) in biological samples (whole blood, serum, or urine). This qualitative determination aids in diagnosing a physiological state.
No
The device description clearly indicates a physical test kit utilizing antibodies and a red blood cell separation media, which are hardware components, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative determination of human chorionic gonadotropin (hCG) in whole blood, serum or urine". This involves testing biological samples in vitro (outside the body).
- Device Description: The description details how the test works by utilizing antibodies and separating blood components, which are typical characteristics of IVD devices.
- Sample Types: The test uses whole blood, serum, and urine, all of which are biological samples commonly used in IVD testing.
The definition of an IVD device is a medical device that is used to perform tests on samples such as blood, urine, or tissue to detect diseases or other conditions. This device clearly fits that description.
N/A
Intended Use / Indications for Use
SAS™ Blood/Serum/Urine hCG is a visual and rapid test for the qualitative determination of human chorionic gonadotropin (hCG) in whole blood, serum or urine to aid in the early detection of pregnancy.
The test is for professional use.
Product codes
JHI
Device Description
The SAS™ Blood/Serum/Urine Test utilizes the same antibodies and 90% of the same test construction of the Modified SAS Serum/Urine test. The most significant difference in the SAS Blood/Serum/Test is that it utilizes a red blood cell separation media that separates plasma from the whole blood cell component. These modifications do not affect the performance, safety or efficacy of the product.
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)
The SAS Blood/Serum/Urine Test utilizes the same antibodies and 90% of the same test construction of the Modified SAS Serum/Urine test. The most significant difference in the SAS Blood/Serum/Test is that it utilizes a red blood cell separation media that separates plasma from the whole blood cell component. These modifications do not affect the performance, safety or efficacy of the product. Please refer to the data included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 10 mIU/mL Serum, 10 mIU/mL Whole Blood, 20 mIU/mL Urine
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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§ 862.1155 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
((022683
510(k) Summary
DEC 1 6 2002
The following table details the comparison of the SAS™ Blood/Serum/Urine hCG to the Modified SAS Serum/Urine hCG Test.
| | SAS Serum/Urine hCG
Test | SAS Blood/Serum/Urine hCG |
|--------------------------------|---------------------------------------------|--------------------------------------------------------------|
| Name | SAS Serum Urine hCG | SAS Blood/Serum/Urine hCG |
| Format | Lateral flow | Lateral Flow |
| Cassette | Image: Cassette diagram with labels S and C | Image: Cassette diagram with labels C and T |
| Cassette Packaging | Individual Pouch | Individual Pouch |
| Sample Type | Serum or Urine | Serum, Urine or Whole Blood
For whole blood sample only |
| Buffer | No | No |
| Blood Cell Separation
Media | No | Yes |
| Sensitivity | 10 mIU/mL Serum
20 mIU/mL Urine | 10 mIU/mL Serum
10 mIU/mL Whole Blood
20 mIU/mL Urine |
| Sample Size | 3-4 drops | 3 drops |
| Read Time | 4 minutes Urine
7 minutes Serum | 4 minutes Urine
7 minutes Serum
15 minutes Whole Blood |
| Kit Size | 30, 50 Tests | 1,25, 30, 50, 100 Tests |
The SAS Blood/Serum/Urine Test utilizes the same antibodies and 90% of the same test construction of the Modified SAS Serum/Urine test. The most significant difference in the SAS Blood/Serum/Test is that it utilizes a red blood cell separation media that separates plasma from the whole blood cell component. These modifications do not affect the performance, safety or efficacy of the product. Please refer to the data included in this submission.
Prepared by: Ricardo R. Martinez on 08/06/2002.
SA Scientific, Inc 4919 Golden Quail San Antonio, Texas 78240 210.699.8800 Fax: 210.699.6545
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with three lines forming its head and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle image. The text is in all caps and is written in a simple, sans-serif font.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Ricardo R. Martinez Director of Regulatory Affairs SA Scientific, Inc. 4919 Golden Quail San Antonio, TX 78240
DEC 16 2002
K022683 Trade/Device Name: SASTM Blood/Serum/Urine hCG Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI Dated: October 28, 2002 Received: November 4, 2002
Dear Mr. Martinez:
Re:
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 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) 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 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. 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 Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE
Applicant:
SA Scientific, Inc. 4919 Golden Quail San Antonio, TX. 78240 Ph: (210) 699-8800 Fax: (210) 6996545
Establishment Reg. No.: 1645225
501(k) Number: K022683
Device Name:
SAS™ Blood/Serum/Urine hCG
Indications for Use:
SASTM Blood/Serum/Urine hCG is a visual and rapid test for the qualitative determination of human chorionic gonadotropin (hCG) in whole blood, serum or urine to aid in the early detection of pregnancy.
The test is for professional use.
Dan Cooper
Division Sign-Off) Division of Clinical La 510(k) Number
(Please do not write below this line)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
or
Prescription Use
Over-the-Counter