The ACON Quik-Check II Home Pregnancy Test Strip is for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy. It is intended for non-professional, over-the-counter use.

Device Description

The test utilizes a combination of mouse monoclonal and goat polyclonal antibody in conjunction with a proprietary strepavidin-biotin ligand-binding system to qualitatively detect elevated levels of hCG in urine sample. The assay is conducted by dipping the test strip into the urine sample that has been collected in a cup or clean, dry container and observing for the formation of colored lines. The specimen migrates via capillary action along the components of the test strip to react with the colored conjugate. During migration, hCG molecules in the positive urine sample react with the hCG-specific antibodies, which were conjugated with colored particles, and form a colored line on the "Test Region" of the membrane. 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, a colored line at the control (C) region will always appear, indicating adequate sample volume and proper wicking, regardless of the presence of hCG. Absence of this control line in the C region indicates that the test result is "invalid". Therefore, two colored line show up on the test strip indicating a positive result; one line shows up near the wicking end indicating a negative and one line shows up away from the wicking end indicating an invalid result. The ACON Quik-Check II Home Pregnancy Test Strip qualitatively detects hCG in urine with a designated cutoff hCG concentration of 25 mIU/mL. This test has been standardized to the World Health Organization Third International Standard. The addition of hLH (300 mIU/mL), hFSH (1,000 mIU/mL), and hTSH (1,000 IU/mL) to negative (0 mIU/mL hCG) and positive (25 mIU/mL hCG) urine showed no cross-reactivity.

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Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Accuracy (correlation with predicate device)	"an accuracy of over 99% correlation between the two Strip hCG tests."
Reproducibility and Precision (correlation with predicate device)	"an accuracy of over 99% correlation between the two Strip hCG tests."
Ease of use, understanding labeling, reading instructions, interpreting results	"the vast majority of the participants found ACON Quik-Check II Home Pregnancy Test Strip very easy to use, and that they had no trouble understanding the labeling, reading the instructions, or interpreting the results."
Qualitative detection of hCG at 25 mIU/mL cutoff	"The ACON Quik-Check II Home Pregnancy Test Strip qualitatively detects hCG in urine with a designated cutoff hCG concentration of 25 mIU/mL."
Standardization to WHO Third International Standard	"This test has been standardized to the World Health Organization Third International Standard."
No cross-reactivity with hLH (300 mIU/mL), hFSH (1,000 mIU/mL), and hTSH (1,000 IU/mL)	"The addition of hLH (300 mIU/mL), hFSH (1,000 mIU/mL), and hTSH (1,000 IU/mL) to negative (0 mIU/mL hCG) and positive (25 mIU/mL hCG) urine showed no cross-reactivity."

Study Proving Device Meets Acceptance Criteria:

The provided text describes two primary clinical studies and additional laboratory studies to demonstrate the device's performance and substantial equivalence.

Clinical Studies:
- Description: Two studies were conducted comparing the ACON Quik-Check II Home Pregnancy Test Strip to the predicate device, ACON Home Pregnancy Test (K993483).
  - One was a consumer field study.
  - The other was a retrospective focus group study on reproducibility and precision.
- Sample Size:
  - Consumer field study: 113 female participants.
  - Retrospective focus group study: 35 female participants.
- Data Provenance: Not explicitly stated, but the "consumer field study" and "retrospective focus group study" suggest the data likely originated from prospective collection for the consumer field study and retrospective analysis of collected data for the focus group study. The country of origin is not mentioned.
- Number and Qualifications of Experts for Ground Truth: Not applicable or not specified for these particular studies, as the comparison was made against a predicate device (ACON Home Pregnancy Test - K993483), not against an independent expert assessment of pregnancy status.
- Adjudication Method: Not specified.
- MRMC Comparative Effectiveness Study: No, this type of study was not conducted or reported. The studies focused on comparing the new device against a predicate device's performance.
- Standalone Performance: Yes, the device's performance (qualitative detection of hCG at 25 mIU/mL, standardization, cross-reactivity) was evaluated independently in laboratory studies. The "consumer field study" and "retrospective focus group study" also assess the device's standalone performance in real-world or simulated user environments, comparing its results to a predicate device.
- Type of Ground Truth: The ground truth for these clinical studies was essentially the result obtained from the legally marketed predicate device (ACON Home Pregnancy Test - K993483), which is itself a pregnancy test.
- Sample Size for Training Set: Not applicable. These were performance evaluation studies, not algorithm training.
- How Ground Truth for Training Set was Established: Not applicable.
Additional Laboratory Studies:
- Description: These studies investigated specificity, interference substances, urinary pH, urinary specific gravity, and the hook effect.
- Sample Size: Not specified.
- Data Provenance: Not specified, but generally laboratory studies are controlled experimental settings.
- Number and Qualifications of Experts for Ground Truth: Not applicable, as these were analytical performance studies using known concentrations of substances or controlled conditions.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: No.
- Standalone Performance: Yes, these were standalone analytical performance tests to establish the device's robustness and accuracy under various conditions.
- Type of Ground Truth: These studies used known concentrations of hCG, hLH, hFSH, hTSH and controlled conditions for pH, specific gravity, and the presence of interfering substances. This represents a type of controlled experimental ground truth.
- Sample Size for Training Set: Not applicable.
- How Ground Truth for Training Set was Established: Not applicable.

In summary, the device's acceptance was primarily based on demonstrating a high correlation (over 99%) with a legally marketed predicate device in user studies, along with robust analytical performance shown in laboratory studies.

Summary

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III. 510(k) Summary

"This summary of 510(k) safety and effective ness information is being submitted in accordance with the regulation of SMDA 1990 and 21 CFR 807.92"

"The assigned 510(k) number is KO3304 | "

Device Names:

ACON Quik-Check II Home Pregnancy Test Strip

Common Name:

Pregnancy Test Kit, Over-the-Counter

Classification Name:

Gonadotropin

Name of the Predicate Device

ACON Home Pregnancy Test Strip (K993483)

Medical Specialty:

Clinical Chemistry

Device Description:

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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, a colored line at the control (C) region will always appear, indicating adequate sample volume and proper wicking, regardless of the presence of hCG. Absence of this control line in the C region indicates that the test result is "invalid". Therefore, two colored line show up on the test strip indicating a positive result; one line shows up near the wicking end indicating a negative and one line shows up away from the wicking end indicating an invalid result.

The ACON Quik-Check II Home Pregnancy Test Strip qualitatively detects hCG in urine with a designated cutoff hCG concentration of 25 mIU/mL. This test has been standardized to the World Health Organization Third International Standard. The addition of hLH (300 mIU/mL), hFSH (1,000 mIU/mL), and hTSH (1,000 IU/mL) to negative (0 mIU/mL hCG) and positive (25 mIU/mL hCG) urine showed no cross-reactivity.

Intended Use:

Clinical Studies:

Clinical studies were conducted to compare the results of ACON Quik-Check II Home Pregnancy Test Strip to the current ACON Home Pregnancy Test (K993483). The consumer field study included 113 female participants and demonstrated an accuracy of over 99% correlation between the two Strip hCG tests. The retrospective focus group study on reproducibility and precision included 35 female participants and demonstrated an accuracy of over 99% correlation between the two Strip hCG tests. The results also showed that the vast majority of the participants found ACON Quik-Check II Home Pregnancy Test Strip very easy to use, and that they had no trouble understanding the labeling, reading the instructions, or interpreting the results.

Additional Laboratory Studies to Establish Substantial Equivalence:

Additional laboratory study results on performance include specificity, interference substances. urinary pH, urinary specific gravity, and does hook effect. These results indicate that the ACON Quik-Check II Home Pregnancy Test Strip is robust and will give accurate results under many adverse conditions.

The overall performance data indicate that ACON Ouik-Check II Home Pregnancy Test Strip is safe, effective and substantially equivalent to ACON Home Pregnancy Test (K993483) currently on the U. S. OTC market.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 wavy lines extending from its head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 2 1 2003

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

Re: K033041

Trade/Device Name: ACON Quik-Check II Home Pregnancy Test Strip Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: September 26, 2003 Received: September 29, 2003

Dear Dr. Tung:

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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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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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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V. Indications For Use

510(k) Number: K03 304 )

Device Name: ACON Quik-Check II Home Pregnancy Test Strip

The ACON Quik-Check II Home Pregnancy Test Strip is for the "Indications for Use": qualitative detection the elevated level of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy. It is intended for non-professional, over-the-counter use.
Alberto Cutin
__, Division Sign-Off for Jean Cooper

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K033041.

(Please do not write below this point)

Concurrence of CDRH, Office of the In vitro Diagnostic Device Evaluation and Safety

Prescription Use

V Over-The-Counter Use

(per 21 CFR 801.109)

Regulation Number and Section

§ 862.1155 Human chorionic gonadotropin (HCG) test system.

(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)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.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. 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.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.