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

Device Description

The test utilizes a combination of mouse monoclonal antibody conjugated with a proprietary dye-binding system and goat polyclonal antibody to qualitatively detect elevated levels of hCG in urine 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 GREEN colored zone in the control (C) region will always be cleared to expose a RED line, indicating adequate sample volume and proper wicking, regardless of the presence of hCG. The presence of the green dye or absence of the red control line in the C region indicates that the test result is "invalid".

The ACON SPECTRUM hCG Midstream Pregnancy Test qualitatively detects hCG in urine 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 LH (300 mIUmL), FSH (1,000 mIU/mL), and TSH (1,000 µIU/mL) to negative (0 mIUmL hCG) and positive (25 mIU/mL hCG) urine samples showed no interference in correctly reading the expected test results.

AI/ML Overview

The ACON SPECTRUM hCG Midstream Pregnancy Test is a qualitative over-the-counter pregnancy test.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ACON SPECTRUM hCG Midstream Pregnancy Test are based on its ability to qualitatively detect human Chorionic Gonadotropin (hCG) in urine at a designated cutoff concentration of 25 mIU/mL. The study performed aims to demonstrate performance equivalency to a legally marketed predicate device. While specific numerical acceptance criteria (e.g., sensitivity, specificity percentages) are not explicitly stated in the provided text for the new device, the reported performance is described in comparison to a predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Qualitative detection of hCG in urine at 25 mIU/mL cutoff.	Standardized to WHO Fourth International Standard for Chorionic Gonadotropin (NIBSC Code: 75/589).
No interference from LH, FSH, and TSH.	Addition of LH (300 mIU/mL), FSH (1,000 mIU/mL), and TSH (1,000 µIU/mL) to negative (0 mIU/mL hCG) and positive (25 mIU/mL hCG) urine samples showed no interference in correctly reading expected test results.
Performance equivalency to the current ACON Midstream Pregnancy Test (Predicate Device K983090).	Consumer Field Study: Demonstrated performance equivalency between the new ACON SPECTRUM hCG Midstream Pregnancy Test and the current ACON Midstream Pregnancy Test. Retrospective Focus Group Study: Demonstrated high degree of correlation between the new ACON SPECTRUM hCG Midstream Pregnancy Test and the current ACON Midstream Pregnancy Test in terms of reproducibility and precision.
Ease of use and clear interpretability for consumers.	The vast majority of participants found the new test very easy to use, and had no trouble understanding the labeling, reading instructions, or interpreting results.
Robustness and accuracy under various conditions.	Additional laboratory studies (specificity, interference substances, urinary pH, urinary specific gravity, dose hook effect, sample and dip time flexibility, and urination studies) indicate the device is robust and will give accurate results under many adverse conditions.

2. Sample Size Used for the Test Set and Data Provenance

Consumer Field Study: "A consumer field study conducted in the U.S. by consumers with varying social-economic backgrounds." The exact sample size is not specified.
Retrospective Focus Group Study: The exact sample size is not specified.
Data Provenance: The consumer field study was conducted in the U.S., indicating the data is from the United States. Both the consumer field study and the retrospective focus group study are described, suggesting a mix of prospective (consumer field study) and retrospective (focus group study) data collection methods, although specifics are limited.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number of experts or their qualifications used to establish ground truth for the consumer field or focus group studies. The primary comparison appears to be between the new device and a predicate device, as well as against the expected results based on known hCG concentrations. The "ground truth" for the non-interference studies was established by preparing urine samples with known hCG concentrations (0 mIU/mL and 25 mIU/mL) and adding known concentrations of LH, FSH, and TSH.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (like 2+1, 3+1, none) for the test set results. For the consumer field study and focus group, the consumers themselves were interpreting the results, and their interpretation was correlated with the predicate device. For the laboratory studies, the expected outcome (positive/negative) was based on the prepared sample concentrations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was mentioned. This device is a visually read, over-the-counter pregnancy test, not an AI-assisted diagnostic tool for expert readers.

6. Standalone Performance Study

Yes, a standalone performance study was done implicitly and explicitly:

The device's ability to "qualitatively detect elevated levels of hCG in urine" at a designated cutoff of 25 mIU/mL was assessed. This is a standalone performance metric.
The non-interference studies with LH, FSH, and TSH, and the various other additional laboratory studies (specificity, urinary pH, specific gravity, dose hook effect, etc.) assess the standalone performance of the ACON SPECTRUM hCG Midstream Pregnancy Test in various controlled conditions.

7. Type of Ground Truth Used

The ground truth for the performance claims appears to be a combination of:

Known concentrations of hCG: For establishing sensitivity at the 25 mIU/mL cutoff and for interference studies (0 mIU/mL hCG for negative, 25 mIU/mL hCG for positive). These concentrations are standardized to the World Health Organization Fourth International Standard for Chorionic Gonadotropin (NIBSC Code: 75/589).
Results from a predicate device: The current ACON Midstream Pregnancy Test (K983090) served as a comparator for equivalency in the consumer field study and retrospective focus group.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. This device is a chemical-based assay with visual interpretation, not an algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no mention of a training set for an AI/algorithm-based device.

Summary

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K042151

510(k) Summary XV.

Device Names:

ACON SPECTRUM hCG Midstream Pregnancy Test

Common Name:

Pregnancy Test Kit, Over-the-Counter

Medical Specialty:

Clinical Chemistry

Intended Use:

Device Description:

The ACON SPECTRUM hCG Midstream Pregnancy Test qualitatively detects hCG in urine sample with a designated cutoff hCG concentration of 25 mIU/mL. The cutoff

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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 LH (300 mIUmL), FSH (1,000 mIU/mL), and TSH (1,000 µIU/mL) to negative (0 mIUmL hCG) and positive (25 mIU/mL hCG) urine samples showed no interference in correctly reading the expected test results.

Clinical Studies:

A consumer field study conducted in the U.S. by consumers with varying socialeconomic backgrounds demonstrated performance equivalency between the current ACON Midstream Pregnancy Test and the new ACON SPECTRUM hCG Midstream Pregnancy Test. A retrospective focus group study on reproducibility and precision also demonstrated high degree of correlation between the current ACON Midstream Pregnancy Test and the new ACON SPECTRUM hCG Midstream Pregnancy Test. The vast majority of the participants also found the new ACON SPECTRUM hCG Midstream Pregnancy Test 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, sample and dip time flexibility, and urination studies are also included in this submission. These results indicate that the ACQN SPECTRUM hCG Midstream Pregnancy Test is robust and will give accurate results under many adverse conditions.

Substantial Equivalency on Performance:

The overall performance data indicate that the new ACON SPECTRUM hCG Midstream Pregnancy Test is safe, effective and substantially equivalent to the current ACON Midstream Pregnancy Test (K983090) legally sold on the U. S. market.

Contact Information:

Edward Tung, Ph.D. Regulatory Affairs ACON Laboratories, Inc. San Diego, CA 92121

Tel. 858-535-2030 Ext. 1072; Fax 858-535-2038 Email: etung@aconlabs.com

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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SEP - 9 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K042151

Trade/Device Name: ACON SPECTRUM hCG Midstream Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: August 5, 2004 Received: August 9, 2004

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,

Jean M. Cooper US, Div.

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:	K042151
Device Name:	ACON SPECTRUM hCG Midstream Pregnancy Test

"Indications for Use": The ACON SPECTRUM hCG Midstream Pregnancy Test is
intended for the qualitative identification of the elevated level of
human Chorionic Gonadotropin (hCG) in urine to aid in the
determination of pregnancy. It is for over-the-counter consumer
use.

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

x Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 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 C. Benson
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) _

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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.