ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST

K980736 · Acon Laboratories Co. · JHI · Apr 16, 1998 · Clinical Chemistry

Device Facts

• Record ID: K980736
• Device Name: ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST
• Applicant: Acon Laboratories Co.
• Product Code: JHI · Clinical Chemistry
• Decision Date: Apr 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The ACON hCG Urine/Serum One Step Pregnancy Test is intended for the qualitative detection of human chorionic gonadotropin in urine or serum.

Device Story

Rapid chromatographic immunoassay (membrane particle assay) for qualitative detection of human chorionic gonadotropin (hCG) in urine or serum. Device consists of test strips; user applies specimen to strip; hCG presence indicated by appearance of colored lines. Used in clinical laboratories and physician offices by healthcare professionals. Provides rapid visual result (3-5 minutes) to aid in early pregnancy detection. Benefits patient by providing timely diagnostic information for clinical decision-making.

Clinical Evidence

Multi-center clinical evaluation compared 155 urine and 57 serum specimens against a commercially available membrane particle assay. Results showed 100% overall agreement. Sensitivity testing confirmed detection limit of 25 mIU/ml. Specificity testing showed no cross-reactivity with high physiological concentrations of LH (300 mIU/ml), FSH (1000 mIU/ml), or TSH (1000 μIU/ml). Interference studies confirmed no impact from common substances including acetaminophen, caffeine, and glucose.

Technological Characteristics

Rapid chromatographic membrane particle immunoassay. Standardized to WHO Third International Standard. Form factor: test strips. Storage: 15° to 30° C. Test time: 3 to 5 minutes. Sensitivity: 25 mIU/ml. No software or electronic components.

Indications for Use

Indicated for the early detection of pregnancy in human urine or serum. Intended for use in clinical laboratories and physician offices.

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

• TestPack®Plus™ hCG Combo pregnancy test (K903219)

Submission Summary (Full Text)

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APR 16 1998

# K980736

6

## ATTACHMENT A

## Revised 510(k) Summary

ACON hCG Urine/Serum One Step Pregnancy Test Strip

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## 10. 510(k) Summary

A. Name and Address of Submitter

Acon Laboratories, Inc. 115 Research Drive Bethlehem, PA 18015 Telephone: [phone] FAX: [phone] Contact Person: Patricia E. Bonness, Official Correspondent Date 510(k) Summary was prepared: April 3, 1998

## B. Device Names

Proprietary Name: ACON® hCG Urine/Serum One Step Pregnancy Test

Common Name: Pregnancy Test

Classification Name: Human Chorionic Gonadotropin (hCG) Test System

## C. Legally Marketed Device

The ACON® hCG Urine/Serum One Step Pregnancy Test has been determined to be substantially equivalent to the TestPack®Plus™ hCG Combo pregnancy test (K903219) currently in commercial distribution by Abbott.

## D. Device Description

The ACON hCG Urine/Serum One Step Pregnancy Test is a rapid chromatographic immunoassay (membrane particle assay).

- E. Intended Use
The ACON hCG Urine/Serum One Step Pregnancy Test is intended for the qualitative detection of human chorionic gonadotropin in urine or serum.

## F. Comparison with Predicate Device

A summary comparison of the features of the ACON hCG and the TestPack®Plus™ hCG Combo pregnancy tests is provided in Table 1 on the following page.

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## Table 1

## Feature Comparison of the ACON hCG and TestPack®Plus™ hCG Pregnancy Tests

| Parameter | ACON hCG | TestPack®Plus™ hCG |
|--------------------|----------------------------------------------------|----------------------------------------------------|
| Intended Use | qualitative detection of<br>hCG in urine and serum | qualitative detection of<br>hCG in urine and serum |
| Indication for Use | early detection of<br>pregnancy | early detection of pregnancy |
| Specimen | urine and serum | urine and serum |
| Endpoint | colored lines | colored lines, plus & minus |
| Format | test strips | test strips within a device |
| Methodology | membrane particle assay | membrane particle assay |
| Storage | 15° to 30° C | 15° to 30° C |
| Test Time | 3 to 5 minutes | 3 to 5 minutes |
| Sensitivity | 25 mIU/ml | 20 mIU/ml |
| Accuracy | $≥$ 99% | $≥$ 99% |
| Specificity | No interferences | No interferences |
| Standardization | WHO Third International<br>Standard | WHO Third International<br>Standard |

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## G. Performance Data

### Accuracy

A multi-center clinical evaluation was conducted which compared the results obtained in tests of 155 urine specimens using the ACON hCG Urine/Serum One Step Pregnancy Test and another commercially available membrane particle assay . The results of this study showed that both tests identified the same 76 negative and 79 positive results. The serum study included 57 specimens and both assays identified 38 negative and 19 positive results. The results of both urine and serum studies demonstrate a 100% overall agreement (for an Accuracy of ≥99%) of the ACON hCG Urine/Serum One Step Pregnancy Test in comparison to the other serum/urine test.

#### Sensitivity

Sensitivity was determined by spiking 20 clinical samples from normal, nonpregnant females with five different concentrations of hCG (0, 15, 20, 50, 100 mIU/ml). The detection limit claimed for the ACON hCG pregnancy test is 25 mIU/ml. All samples tested at concentrations of hCG as low as 15 mIU/ml produced positive results.

## Specificity

Specificity studies were performed on specimens with high physiological concentrations of luteinizing hormone (LH), follicle stimulating hormone (FSH), and thyroid stimulating hormone (TSH). Negative results were obtained with all specimens tested with 300 mIU/ml hLH, 1000 mIU/ml hFSH, and 1000μJU/ml hTSH.

#### Interfering Substances

No interference was observed in studies of specimens containing the following substances:

| Acetaminophen | 20 | mg/dl |
|----------------------|----|-------|
| Acetylsalicylic acid | 20 | mg/dl |
| Ascorbic acid | 20 | mg/dl |
| Atropine | 20 | mg/dl |
| Caffeine | 20 | mg/dl |
| Gentisic acid | 20 | mg/dl |
| Glucose | 2 | g/dl |
| Hemoglobin | 1 | mg/dl |

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 16 1998

Patricia E. Bonness . Official Correspondent Acon Laboratories, Inc. 115 Research Drive Bethlehem, Pennsylvania 18015

K980736 Re : ACON™ hCG Urine/Serum One Step Pregnancy Test Regulatory Class: II Product Code: JHI Dated: February 23, 1998 Received: February 25, 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 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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. ದ 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 requlations.

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Page 2

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 leqally 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.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Gutman

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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Page 1 of 1

510(k) Number (if known): K980736

Device Name: ACON™hCG Urine/Serum One Step Pregnancy Test

Indications For Use:

The ACON hCG Urine/Serum One Step Pregnancy Test is a rapid qualitative chromatographic immunoassay for the detection of human chorionic gonadotropin in urine or serum.

The ACON hCG Urine/Serum One Step Pregnancy Test is indicated for use as an aid in the early detection of pregnancy. This device is intended to be used in the clinical laboratory and/or physician's office.

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

#### Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

510(k) Number _

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Clinical Laboratory Devices