(126 days)
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.
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.
The provided text describes a 510(k) submission for the SASTM Blood/Serum/Urine hCG diagnostic device. This is a point-of-care test for pregnancy detection. The submission primarily focuses on demonstrating substantial equivalence to a predicate device.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided text does not explicitly state specific acceptance criteria (e.g., minimum sensitivity, specificity, or accuracy percentages) or detailed performance data for the SASTM Blood/Serum/Urine hCG device against such criteria. Instead, it focuses on comparing the new device's features and characteristics to a modified version of a predicate device (Modified SAS Serum/Urine hCG Test) and asserts that "These modifications do not affect the performance, safety or efficacy of the product."
The table provided is a comparison of device characteristics, not a performance table against pre-defined acceptance criteria.
| Characteristic | SAS Serum/Urine hCG Test (Predicate) | SASTM Blood/Serum/Urine hCG (New Device) |
|---|---|---|
| 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 applies) |
| Buffer | No | No |
| Blood Cell Separation Media | No | Yes |
| Sensitivity | 10 mIU/mL Serum20 mIU/mL Urine | 10 mIU/mL Serum10 mIU/mL Whole Blood20 mIU/mL Urine |
| Sample Size | 3-4 drops | 3 drops |
| Read Time | 4 minutes Urine7 minutes Serum | 4 minutes Urine7 minutes Serum15 minutes Whole Blood |
| Kit Size | 30, 50 Tests | 1, 25, 30, 50, 100 Tests |
The statement "These modifications do not affect the performance, safety or efficacy of the product. Please refer to the data included in this submission" strongly implies that the performance (sensitivity and specificity) is expected to be equivalent to the predicate, with the primary change being the addition of whole blood testing capability and the associated blood cell separation media. However, the specific data demonstrating this equivalence is not present in the provided snippets.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided text does not include information on the sample size used for any test set or the data provenance (country of origin, retrospective/prospective). It mentions "data included in this submission" but the data itself is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The provided text does not include information on the number or qualifications of experts used to establish ground truth. For a pregnancy test, ground truth would typically be established by laboratory methods (e.g., quantitative hCG assays) rather than expert review of images, but the document doesn't detail this.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The provided text does not include information on any adjudication method.
5. 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
This question is not applicable to the SASTM Blood/Serum/Urine hCG device. This device is a rapid diagnostic test for hCG, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to the SASTM Blood/Serum/Urine hCG device. It is a lateral flow immunoassay that human users read visually, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The provided text does not explicitly state the type of ground truth used. However, for an hCG test, the typical ground truth would be established by comparing the rapid test results to a more sensitive and quantitative laboratory method (e.g., a laboratory-based quantitative immunoassay for hCG) or clinical outcomes (e.g., confirmation of pregnancy by ultrasound or subsequent clinical events).
8. The sample size for the training set
The provided text does not include information on any training set sample size. This type of information is typically relevant for machine learning or AI models, which is not the case for this device.
9. How the ground truth for the training set was established
The provided text does not include information on how ground truth was established for a training set. As mentioned in point 8, this device is not an AI/ML system.
In summary:
The provided document is a 510(k) summary for a rapid diagnostic pregnancy test, focusing on demonstrating substantial equivalence to a predicate device based on manufacturing and design similarities. It lacks detailed performance data, study methodologies, or information about specific acceptance criteria, expert involvement, or ground truth establishment that would be present in a comprehensive study report. The core assertion is that the modifications (primarily adding whole blood compatibility) do not affect the device's performance, safety, or efficacy, and this is supported by "data included in this submission" which is not provided here.
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((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 hCGTest | 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 BloodFor whole blood sample only |
| Buffer | No | No |
| Blood Cell SeparationMedia | No | Yes |
| Sensitivity | 10 mIU/mL Serum20 mIU/mL Urine | 10 mIU/mL Serum10 mIU/mL Whole Blood20 mIU/mL Urine |
| Sample Size | 3-4 drops | 3 drops |
| Read Time | 4 minutes Urine7 minutes Serum | 4 minutes Urine7 minutes Serum15 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
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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
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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
§ 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.