ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE) by ACON LABORATORIES, INC.

ACON™ hCG One Step Pregnancy Test Device (Urine) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid for the early detection of pregnancy. The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of hCG. The assay is conducted by adding specimen to the test device and observing for the formation of colored lines. The specimen migrates via capillary action along the membrane to react with the colored conjugate. Positive specimens react with the specific antibody-hCG-colored conjugate and form a colored line in the Test Area of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line in the Control Area will always appear regardless of the presence or absence of hCG.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the ACON™ hCG One Step Pregnancy Test Device (Urine), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Acceptance Criteria (Implied/Direct)	Reported Device Performance
Qualitative Detection of hCG	Detection of hCG in urine as an aid for early pregnancy detection.	Detects hCG. Positive results correspond to pregnancy.
Concordance with Predicate Device	High concordance (ideally 100%) with another commercially available urine membrane test.	100% concordance with the commercially available test.
Detection Limit (Sensitivity)	To detect hCG concentrations of 25 mIU/ml and greater.	Successfully detects hCG concentrations of 25 mIU/ml and greater.
Cross-Reactivity (Specificity)	No cross-reactivity with hLH (300mIU/ml), hFSH (1000 mIU/ml), and hTSH (1000uIU/ml).	No cross-reactivity observed with specified hormones.

2. Sample Sizes Used for the Test Set and Data Provenance:

Test Set Sample Size: 159 urine specimens.
Data Provenance: The document states "A multi-center clinical evaluation was conducted," implying the data was collected from multiple locations. It does not explicitly state the country of origin, but the submission is to the US FDA, and the company is based in San Diego, CA, USA, suggesting it's likely US-based or international data submitted for US approval. The study appears to be prospective in comparing the new device against a predicate.

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

The document describes a comparative study against "another commercially available urine membrane test." The results of this predicate device were used as the comparator, essentially serving as a surrogate for ground truth.
The number of experts involved in determining the "truth" for the predicate device's results is not specified. The qualifications of anyone interpreting the predicate device's results are also not specified.

4. Adjudication Method for the Test Set:

The text describes a direct comparison: "comparing the results obtained using ACON™ hCG One Step Pregnancy Test Device (Urine) and another commercially available urine membrane test."
There is no mention of an adjudication method (e.g., 2+1, 3+1) because the comparison is directly between the new device and an established predicate device's results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study was not done. The study's design was a direct comparison of the new device's performance against a predicate device, not an evaluation of how human readers improve with or without AI assistance. The device itself is a diagnostic test, not an AI-assisted diagnostic tool for human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, a standalone study was done. The ACON™ hCG One Step Pregnancy Test Device (Urine) is a rapid chromatographic immunoassay. Its performance, as reported in the study, refers to the device's ability to detect hCG independently, without human interpretation beyond reading the lines on the test strip according to instructions. The comparison is the device's output against the predicate device's output.

7. The Type of Ground Truth Used:

The "ground truth" for the comparative study was based on the results obtained from another commercially available urine membrane test (predicate device). This serves as a clinical reference or comparator standard.
In terms of the device's intrinsic capabilities (sensitivity and specificity testing), the ground truth for sensitivity was based on known hCG concentrations (25 mIU/ml) standardized to the World Health Organization Third International Standard, and for specificity, it was based on known concentrations of interfering hormones.

8. The Sample Size for the Training Set:

The document does not specify a training set sample size. This type of immunoassay device is typically developed and validated through laboratory testing and then clinical evaluation, rather than through a machine learning paradigm that relies on distinct training and test sets in the same way. The 159 urine specimens were the test set for clinical performance.

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

As a traditional immunoassay, the concept of a "training set" and associated "ground truth" derived from expert consensus or pathology, etc., is not applicable in the same way it would be for AI/machine learning algorithms.
The development and calibration of such a device primarily involve optimizing antibody-antigen reactions, membrane characteristics, and visual signal development to achieve desired sensitivity and specificity targets in laboratory settings, often using controlled samples with known hCG concentrations. The "ground truth" in this context would be the precisely measured hCG concentrations in spiked samples or reference materials used during assay development and calibration.

Summary

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K993317

"Summary of Safety & Effectiveness"

A multi-center clinical evaluation was conducted comparing the results obtained using ACON™ hCG One Step Pregnancy Test Device (Urine) and another commercially available urine membrane test. The study included 159 urine specimens tested with both assays. The following results were found:

	PositiveResults	NegativeResults
ACON™ hCG One StepCommerciallyAvailable Test	71	88
	71	88

ACON™ hCG One Step Pregnancy Test Device (Urine) showed a 100% concordance with the other commercially available test.

ACON™ hCG One Step Pregnancy Test Device (Urine) detects hCG concentrations of 25 mIU/ml and greater. The test has been standardized to the World Health Organization Third International Standard. The addition of hLH (300mUVml, hFSH (1000 mIU/ml), and hTSH (1000uIU/ml) to negative and positive serum and urine specimens showed no cross-reactivity.

Ara C.R. York

Nora C.R. York ACON Laboratories, Inc. 11175 Flintkote, Avenue, Suite F San Diego. CA 92121 UDA

10/1/99
Date

Premarket Notification 510(k) Number

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC - 1 1999

Ms. Nora C.R. York Regulatory Affairs Manager Acon Laboratories, Inc. 11175 Flintkote Avenue Suite F San Diego, California 92121

Re: K993317

Trade Name: Acon™ hCG One Step Pregnancy Test Device (Urine) Regulatory Class: II Product Code: JHI Dated: October 1, 1999 Received: October 4, 1999

Dear Ms. York:

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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A 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 regulations.

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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 (770) 488-7655.

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 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 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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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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Indications For Use

510(k)Number:_________________________________________________________________________________________________________________________________________________________________

Device Name: ACON™ hCG One Step Pregnancy Test Device (Urine)

"Indications For Use" - ACON™ hCG One Step Pregnancy Test Device (Urine) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid for the early detection of pregnancy. This test is for professional use.

(Please do not write below this point)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ﻟﺴﻴ Prescription Use_

(per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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.