ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE

K041946 · ACON Laboratories, Inc. · JHI · Aug 16, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041946
• Device Name: ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE
• Applicant: ACON Laboratories, Inc.
• Product Code: JHI · Clinical Chemistry
• Decision Date: Aug 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The ACON® SPECTRUM Urine/Serum Pregnancy Test Device is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum to aid in the early detection of pregnancy. The ACON® SPECTRUM Urine/Serum Pregnancy Test Device is intended for the qualitative identification the elevated level of human Chorionic Gonadotropin (hCG) in urine and serum to aid in the determination of pregnancy. It is for healthcare professionals only.

Device Story

Rapid chromatographic immunoassay; detects hCG in urine or serum samples. Employs mouse monoclonal antibody conjugated with dye-binding system and goat polyclonal antibody. Sample migrates via capillary action; hCG binds to conjugate and polyclonal antibody at test region. Positive result indicated by colored line in test (T) region; control (C) region confirms adequate sample volume. Used in clinical settings by healthcare professionals. Provides qualitative visual output to aid pregnancy diagnosis; facilitates early clinical decision-making.

Clinical Evidence

Clinical study conducted at two U.S. sites by healthcare professionals demonstrated performance equivalency to predicate. Retrospective focus group study confirmed reproducibility and precision with high correlation. Participants reported ease of use and clarity in interpreting results. Additional laboratory studies confirmed robustness regarding specificity, interference, pH, specific gravity, dose hook effect, and volume flexibility.

Technological Characteristics

Sandwich immunochromatographic assay. Materials: mouse monoclonal antibody, goat polyclonal antibody, proprietary dye-binding system. Form factor: test device with disposable droppers. Sensitivity: 25 mIU/mL. Storage: 2-30°C. No electronic components, software, or connectivity.

Indications for Use

Indicated for qualitative detection of elevated hCG in urine and serum to aid pregnancy determination. For use by healthcare professionals only.

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

• ACON® hCG Urine/Serum One Step Pregnancy Test Device (k993065)

Submission Summary (Full Text)

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K041946

AUG 1 6 2004

#### 510(k) Summary XV.

## Device Names:

ACON SPECTRUM Urine/Serum Pregnancy Test Device

## Common Name:

Pregnancy Test Kit, Professionals

## Medical Specialty:

Clinical Chemistry

## Intended Use:

The ACON SPECTRUM Urine/Serum Pregnancy Test Device is for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine and serum to aid in the determination of pregnancy. It is for healthcare professionals only.

#### Device Description:

The test utilizes a combination of mouse monoclonal antibody conjugated with a proprietary dyebinding system and goat polyclonal antibody to qualitatively detect elevated levels of hCG in urine and serum samples. Test may be done by applying sample and observing visually for the formation of colored lines. After sample application, specimen migrates via capillary action along the components of the test. During migration, hCG molecule in the sample reacts with the monoclonal hCG antibodies-dye conjugate, and also reacts with the polyclonal hCG antibody striped down at the test region of the membrane to form an antibody-antigen-antibody-dye complex as a colored test line. Therefore, a colored line forms in the test (T) region indicates a positive result; while absence of this colored line indicates a negative result.

To serve as a procedural control, if the test has been performed properly, a RED colored zone in the control (C) region will always be cleared to expose a BLUE line, indicating adequate sample volume and proper wicking, regardless of the presence of hCG. The presence of the red dye or absence of the blue control line in the C region indicates that the test result is "invalid".

The ACON SPECTRUM Urine/Serum Pregnancy Test Device qualitatively detects hCG in urine or serum sample with a designated cutoff hCG concentration of 25 mIU/mL. The cutoff concentration of this test has been standardized to the World Health Organization Fourth International Standard for Chorionic Gonadotropin (NIBSC Code: 75/589). The addition of hLH (300 mIU/mL), hFSH (1,000 mIU/mL), and hTSH (1,000 µIU/mL) to negative (0 mJU/mL hCG)

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and positive (25 mIU/mL hCG) urine and serum samples showed no interference in correctly read the expected test results.

## Clinical Studies:

A clinical study was conducted in two sites in the U.S. by healthcare professionals with varying educational backgrounds and laboratory experience and demonstrated performance equivalency between the current and the new ACON hCG tests by professionals. A retrospective focus group study on reproducibility and precision also demonstrated high degree of correlation between the current and the new ACON hCG tests. The vast majority of the participants also found the ACON SPECTRUM Urine/Serum Pregnancy Test Device very easy to use, and that they have had no trouble understanding the labeling, reading the instructions, or interpreting the results.

## Additional Laboratory Studies:

Additional laboratory study results on performance including specificity, interference substances, urinary pH, urinary specific gravity, dose hook effect, time flexibility, and volume flexibility studies are also included in this submission. These results indicate that the ACON SPECTRUM Urine/Serum Pregnancy Test Device is robust and will give accurate results under many adverse conditions.

## Substantial Equivalency on Performance:

The overall performance data indicate that the ACON SPECTRUM Urine/Serum Pregnancy Test Device is safe, effective and substantially equivalent to the ACON hCG Urine/Serum One Step Pregnancy Test Device (K993065) legally sold on the U. S. market.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with three lines forming a shape resembling a bird or a stylized human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

od and Drug Administration 098 Gaither Road Rockville MD 20850

AUG 1 6 2004

Edward Tung, Ph.D. Director of Regulatory Affairs ACON Laboratories 4108 Sorrento Valley Blvd San Diego, CA 92121

Re: k041946 K041940
Trade/Device Name: ACON SPECTRUM Urine/Serum Pregnancy Test Device Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI Dated: July 16, 2004 Received: July 19, 2004

Dear Dr. Tung:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to connifered prof to May 20, 1978, the occordance with the provisions of the Federal Food, Drug, de vices that have been recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, merelore, manee the act include requirements for annual registration, listing of general controls provisions of tractice, 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 your device to such additional controls. Existing major regulations affecting your device it may be subject to Sach ademonsederal Regulations (CFR), Parts 800 to 895. In addition, FDA ound of found in Titler 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 that I Dr Has made a and regulations administered by other Federal agencies. You must or any I ederal blatates and sequirements, 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). You may obtain other general information on your responsibilities under the Act 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,

Jean M. Cooper, MS, DVM.

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K041946

Device Name: ACON SPECTRUM Urine/Serum Pregnancy Test Device

Indications For Use: The ACON SPECTRUM Urine/Serum Pregnancy Test Device is intended for the qualitative identification the elevated level of human Chorionic Gonadotropin (hCG) in urine and serum to aid in the determination of pregnancy. It is for healthcare professionals only.

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol Benen
Division Sign-Off

Division Sign-Off

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Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K041946