ACON MIDSTREAM PREGNANCY TEST

K983090 · ACON Laboratories, Inc. · LCX · Nov 18, 1998 · Clinical Chemistry

Device Facts

• Record ID: K983090
• Device Name: ACON MIDSTREAM PREGNANCY TEST
• Applicant: ACON Laboratories, Inc.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Nov 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The ACON™ Midstream Pregnancy Test is intended for home use (over-the-counter) for the qualitative detection of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy.

Device Story

The ACON Midstream Pregnancy Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. Designed for home use (OTC), the device utilizes a membrane particle assay format. The user collects a urine sample, which migrates across the test strip. The presence of hCG is indicated by the appearance of colored lines on the test strip. The test provides a qualitative result to aid in the determination of pregnancy. It is a standalone, non-electronic diagnostic tool.

Clinical Evidence

Bench testing only. The device demonstrated an accuracy of ≤99% and specificity showing no interference with LH, FSH, or TSH. Sensitivity is 25 mIU/ml.

Technological Characteristics

Rapid chromatographic membrane particle immunoassay. Qualitative visual endpoint via colored lines. Standardized to WHO Third International Standard. Storage requirements 15° to 30° C. Test time 3 minutes.

Indications for Use

Indicated for home use by individuals for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.

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

• SAS Pregnancy Test (K926204)

Submission Summary (Full Text)

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K983090

NOV 1 8 1998

### 10. 510(k) Summary

A. Name and Address of Submitter

Acon Laboratories, Inc. 3140-B Tilghman Street, Suite 215 Allentown, PA 18104

Telephone: [phone] FAX:

Contact Person: Patricia E. Bonness, Official Correspondent

Date 510(k) Summary was prepared: November 11, 1998

#### B. Device Names

Proprietary Name: ACON™ Midstream Pregnancy Test

Common Name: Pregnancy Test

Classification Name: Human Chorionic Gonadotropin (hCG) Test System

#### C. Legally Marketed Device

The ACON™ Midstream Pregnancy Test has been determined to be substantially equivalent to the SAS Pregnancy Test (K926204) currently in commercial distribution by SA Scientific, San Antonio, TX.

#### D. Device Description

The ACON Midstream Pregnancy Test is a rapid chromatographic immunoassay (membrane particle assay).

#### E. Intended Use

The ACON Midstream Pregnancy Test is intended for home use, in the qualitative detection of human chorionic gonadotropin in urine.

#### F. Comparison with Predicate Device

A summary comparison of the features of the ACON Midstream and the SAS One-Step Pregnancy Tests is provided in Table 1 on the following page.

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### Table 1

# Feature Comparison of the ACON Midstream and SAS One-Step Pregnancy Tests

| Parameter | ACON Midstream | SAS One-Step |
|--------------------|----------------------------------------------------------------------|------------------------------------------------------------------------|
| Intended Use | qualitative detection of<br>hCG in urine and serum<br>home use (OTC) | qualitative detection of<br>hCG in urine and serum<br>professional use |
| Indication for Use | early detection of<br>pregnancy | early detection of pregnancy |
| Specimen | urine | urine |
| Endpoint | colored lines | colored lines |
| Format | test strips in device | test strips in device |
| Methodology | membrane particle assay | membrane particle assay |
| Storage | 15° to 30° C | 15° to 30° C |
| Test Time | 3 minutes | 4 minutes |
| Sensitivity | 25 mIU/ml | 20 mIU/ml |
| Accuracy | ≤99% | ≥99% |
| Specificity | No interferences<br>when tested with<br>LH, FSH and TSH | No interferences |
| Standardization | WHO Third International<br>Standard | WHO Third International<br>Standard |

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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the profiles.

### NOV 1 8 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Patricia E. Bonness Official Correspondent Acon Laboratories, Inc. 3140-B Tilghman Street, Suite 215 Allentown, Pennsylvania 18104

Re: K983090 ACON™ Midstream Pregnancy Test Trade Name: Regulatory Class: II Product Code: LCX Dated: September 2, 1998 Received: September 3, 1998

Dear Ms. Bonness:

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 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). 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 aqainst 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A 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 Druq 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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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 requlation (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/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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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## Statement of Indications For Use

510(k) Number: K983090

Device Name: ACON™ Midstream Pregnancy Test

- ACON™ Midstream Pregnancy Test is intended for home use "Indications For Use" -(over-the-counter) for the qualitative detection of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy.
(Please do not write below this point)

Image /page/4/Picture/5 description: The image shows a form titled "Concurrence of CDRH, Office of Device Evaluation (ODE)". The form indicates "Over-The-Counter Use" with a checkmark. The document includes a signature for the "Division Sign-Off" of the "Division of Clinical Laboratory Devices", and the 510(k) Number is listed as K983090.