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

AI/ML Overview

The provided text describes the ACON SPECTRUM Urine/Serum Pregnancy Test Device, but it does not contain the specific details required to fully populate all sections of the requested table and study information. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed de novo clinical study with specific acceptance criteria and performance metrics against a predefined standard.

However, I can extract what is available and highlight what is missing.

Here's the information based on the provided text:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Qualitative detection of hCG at 25 mIU/mL	Qualitatively detects hCG in urine or serum sample with a designated cutoff hCG concentration of 25 mIU/mL.
No interference from hLH (300 mIU/mL)	No interference observed with hLH (300 mIU/mL) in negative (0 mIU/mL hCG) and positive (25 mIU/mL hCG) urine and serum samples.
No interference from hFSH (1,000 mIU/mL)	No interference observed with hFSH (1,000 mIU/mL) in negative (0 mIU/mL hCG) and positive (25 mIU/mL hCG) urine and serum samples.
No interference from hTSH (1,000 µIU/mL)	No interference observed with hTSH (1,000 µIU/mL) in negative (0 mIU/mL hCG) and positive (25 mIU/mL hCG) urine and serum samples.
Equivalence to predicate device (K993065)	Demonstrated "performance equivalency" and "high degree of correlation" between the current and the new ACON hCG tests by professionals.
Robustness under adverse conditions	"Robust and will give accurate results under many adverse conditions" for specificity, interference substances, urinary pH, urinary specific gravity, dose hook effect, time flexibility, and volume flexibility.
Ease of use	"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."

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated. The text mentions "a clinical study was conducted" and "a retrospective focus group study." It does not provide the number of samples or participants in these studies.
Data Provenance:
- Country of Origin: U.S. ("A clinical study was conducted in two sites in the U.S.")
- Retrospective or Prospective:
  - Clinical Study: Not explicitly stated, but the "retrospective focus group study" is identified as retrospective. The initial clinical study is not labeled as such.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not explicitly stated. The text mentions "healthcare professionals with varying educational backgrounds and laboratory experience."
Qualifications of Experts: "Healthcare professionals with varying educational backgrounds and laboratory experience." Specific qualifications (e.g., "radiologist with 10 years of experience") are not provided.

4. Adjudication method for the test set:

Not mentioned. The text refers to professionals demonstrating performance equivalency and participants finding the device easy to use, but no specific adjudication method (like 2+1 or 3+1) is described for resolving discrepancies or establishing ground truth.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This device is a qualitative test device, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable and was not conducted.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This device is a manual, visually-read test. It does not involve an algorithm, so a standalone algorithm-only performance study is not applicable. The device's performance inherently involves "human-in-the-loop" for visual interpretation.

7. The type of ground truth used:

The text implies that the ground truth for hCG levels was established through controlled spiking of samples or by using samples with known hCG concentrations (e.g., negative (0 mIU/mL hCG) and positive (25 mIU/mL hCG)). The standardization to the World Health Organization Fourth International Standard for Chorionic Gonadotropin (NIBSC Code: 75/589) indicates a well-defined reference for hCG concentration. For the "performance equivalency" study, the predicate device (K993065) likely served as a comparative ground truth.

8. The sample size for the training set:

The document does not explicitly describe a "training set" in the context of machine learning or AI, as this device is a chemical assay. The studies focus on validation and performance. Therefore, a sample size for a training set is not applicable or provided.

9. How the ground truth for the training set was established:

As this is not an AI/ML device, the concept of a "training set" and its associated ground truth establishment is not applicable. The device's performance is based on its chemical reactivity and visual interpretation against known hCG concentrations.

Summary

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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:

Device Description:

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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 (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,

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

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K041946

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.