SAS BLOOD/SERUM/URINE/URINE HCG

K022683 · Sa Scientific, Inc. · JHI · Dec 16, 2002 · Clinical Chemistry

Device Facts

• Record ID: K022683
• Device Name: SAS BLOOD/SERUM/URINE/URINE HCG
• Applicant: Sa Scientific, Inc.
• Product Code: JHI · Clinical Chemistry
• Decision Date: Dec 16, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

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.

Device Story

SAS Blood/Serum/Urine hCG is a lateral flow immunoassay for qualitative hCG detection. Input samples include whole blood, serum, or urine. Device incorporates red blood cell separation media to process whole blood samples. Operation involves applying sample to a test cassette; results are visually interpreted by a healthcare professional. For whole blood, plasma is separated from cellular components via integrated media. Output is a visual qualitative result indicating presence or absence of hCG. Used in clinical settings by professionals to aid in pregnancy diagnosis.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and performance comparison of analytical sensitivity and test construction.

Technological Characteristics

Lateral flow immunoassay; utilizes red blood cell separation media for whole blood samples; qualitative visual readout; manual operation; no electronic components or software.

Indications for Use

Indicated for professional use to qualitatively detect human chorionic gonadotropin (hCG) in whole blood, serum, or urine to aid in early pregnancy detection.

Regulatory Classification

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. 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.

Predicate Devices

• Modified SAS Serum/Urine hCG Test

Submission Summary (Full Text)

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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 hCG<br>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<br>For whole blood sample only |
| Buffer | No | No |
| Blood Cell Separation<br>Media | No | Yes |
| Sensitivity | 10 mIU/mL Serum<br>20 mIU/mL Urine | 10 mIU/mL Serum<br>10 mIU/mL Whole Blood<br>20 mIU/mL Urine |
| Sample Size | 3-4 drops | 3 drops |
| Read Time | 4 minutes Urine<br>7 minutes Serum | 4 minutes Urine<br>7 minutes Serum<br>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: [phone]

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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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## Page 2

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 [phone]. 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 [phone] or [phone] 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: [phone] Fax: [phone]

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