CHOICE ACCU-TEST PREGNANCY TEST KIT

K974154 · Sa Scientific, Inc. · LCX · Dec 19, 1997 · Clinical Chemistry

Device Facts

• Record ID: K974154
• Device Name: CHOICE ACCU-TEST PREGNANCY TEST KIT
• Applicant: Sa Scientific, Inc.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Dec 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

Rapid one-step visual test for the qualitative detection of hCG in human urine to aid in the diagnosis of pregnancy. This test is intended for over-the-counter home use.

Device Story

CHOICE accu-test™ is a lateral flow immunoassay for qualitative hCG detection in human urine; intended for over-the-counter home use. Device utilizes absorbent wick to draw urine sample via capillary action across membrane containing polyclonal and monoclonal antibodies. hCG in sample reacts with conjugate on reagent pad. Positive result indicated by two colored lines; negative result by one colored line. Provides rapid visual confirmation of pregnancy status to assist user in early detection. No external power or processing required.

Clinical Evidence

Bench testing only. Specificity, sensitivity, accuracy, interfering substances, and stability studies demonstrated >99% acceptance. A comparison study of 132 test devices against the SAS™ Serum/Urine hCG Pregnancy Test Kit resulted in >99% accuracy.

Technological Characteristics

Lateral flow immunochromatographic assay; utilizes polyclonal and monoclonal antibodies on a reagent pad and membrane; visual readout via colored lines; capillary action-based fluid transport; standalone, single-use disposable test kit.

Indications for Use

Indicated for the qualitative determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy for over-the-counter home use.

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

• Be Sure® Plus Pregnancy Test Kit

Reference Devices

• SAS™ Serum/Urine hCG Pregnancy Test Kit

Submission Summary (Full Text)

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## 510(K) SUMMARY

DEC 1 9 1997

510(k) Number:

Product Name:

Submitted by:

Contact:

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Classification:

Intended Use:

Description of Device:

**Substantial Equivalence Devi**

Clinical Reference Device:

Performance Data:

K974154

CHOICE accu-test™ One-Step Pregnancy Test

SA Scientific, Inc. 4919 Golden Quail San Antonio, TX, 78240

Mike Crisp Ph: [phone] Fax: [phone]

Human chorionic gonadotropin (hCG) test system

Rapid one-step visual test for the qualitative detection of hCG in human urine to aid in the diagnosis of pregnancy. This test is intended for over-the-counter home use.

CHOICE accu-test™ detects the presence of hCG in urine by using a combination of polyclonal and monoclonal antibodies on the reagent pad and the test strip. The assay begins functioning with the addition of urine onto the absorbent wick. Through capillary action the urine is pulled along the membrane to the reagent pad where the hCG reacts with the conjugate. Positive results are determined by two colored lines in the window. The absence of hCG produces only one colored line in the window.

Substantial Equivalence Device: Be Sure® Plus Pregnancy Test Kit

SAS™ Serum/Urine hCG Pregnancy Test Kit

Specificity, Sensitivity & Accuracy, Interfering Substances, and Stability Studies resulted in >99% acceptance. A Comparison Study of 132 test devices with SAS™ Serum/Urine hCG Pregnancy Test Kits resulted in >99% accuracy.

Date Originally Prepared:

October 31, 1997

Page 17

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 19 1997

Dr. Harbi Shadfan . President SA Scientific, Inc. 4919 Golden Quail San Antonio, Texas 78240

Re : K974154 CHOICE accu-test™ Pregnancy Test Kit Regulatory Class: II Product Code: LCX Dated: October 31, 1997 Received: November 4, 1997

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 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. ਰ 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.

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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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours,
Steven Litman

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

510(k) Number: None

Device Name: CHOICE accu-test™ Pregnancy Test Kit

"Indications For Use" -

CHOICE accu-test™ is a visual and rapid test for the qualitative determination of human chorionic gonadotropin (hCG) in urine to aid in early detection of pregnancy. This test is intended for overthe-counter use.

UMichael W. Anstrom

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K974154

(PLEASE DO NOT WRITE BELOW THIS LINE, CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR (per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)