(98 days)
ACON™ One Step Home Pregnancy Test Strip is intended for nonprofessional use for the qualitative identification of human chorionic gonadotropin (hCG) in urine to aid in the determination of pregnancy.
ACON™ One Step Home Pregnancy Test Strip is intended for non-professional use for the identification of hCG (human chorionic gonadotropin) in urine to aid in the determination of pregnancy. The test utilizes a combination of monoclonal and polyclonal antibody reagents to selectively detect elevated levels of hCG. The assay is conducted by dipping the absorbent wick of the test in urine and observing for the formation of colored lines. The specimen migrates via capillary action along the wick and membrane to react with the colored conjugate. Positive specimens react with the specific antibody-hCG-colored conjugate and form a colored line on the Test portion of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line at the Control zone will always appear regardless of the presence or absence of hCG.
Here's an analysis of the provided text regarding the ACON™ One Step Home Pregnancy Test Strip, structured according to your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Analytical Sensitivity: Detect hCG concentrations of 25 mIU/ml and greater. | Detects hCG concentrations of 25 mIU/ml and greater. (Confirmed) |
| Specificity/Cross-Reactivity: No cross-reactivity with hLH, hFSH, and hTSH at specified concentrations. | No cross-reactivity with hLH (300 mIU/ml), hFSH (1000 mIU/ml), and hTSH (1000μIU/ml) when added to negative and positive urine. (Confirmed) |
| User Comprehension & Ease of Use (for OTC use): Participants found it easy to use, understood labeling, instructions, and interpreted results correctly. | Majority of 73 female participants found it "very easy to use," "had no trouble understanding the labeling," "reading the instructions," or "interpreting the results." (Confirmed) |
| Suitability for Over-the-Counter Pregnancy Testing: Overall performance confirms suitability. | "The overall results of the clinical trial confirm that ACON™ One Step Home Pregnancy Test Strip is a suitable test for over-the-counter pregnancy testing." (Confirmed) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 73 female participants.
- Data Provenance: The document doesn't explicitly state the country of origin. Given the manufacturer's address (San Diego, CA, USA) and submission to the FDA, it's highly likely the study was conducted in the United States. The study appears to be prospective as it involved clinical trials with participants.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts or their qualifications for establishing the ground truth of the pregnancy status in the 73 participants. Given it's a home pregnancy test, the "ground truth" would generally be established by confirming pregnancy status through other clinical methods (e.g., blood tests, physician diagnosis) or the participants' self-reported pregnancy status linked to other medical confirmation.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the interpretation of test results or the establishment of ground truth. For home pregnancy tests, the user themselves is the primary interpreter, and the study focuses on their ability to interpret correctly.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is more common for diagnostic imaging AI where multiple expert readers interpret cases with and without AI assistance to measure human performance improvement. For a home-use diagnostic device like this, the focus is on the general population's ability to use and interpret the test effectively as a standalone device.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone performance evaluation of the device (i.e. the test strip itself, without considering user interpretation accuracy as part of the core performance) was done to establish its analytical performance. The document describes:
- Analytical Sensitivity: "The ACON™ One Step Home Pregnancy Test Strip detects hCG concentrations of 25 mIU/ml and greater." This is a direct measure of the device's inherent capability to detect hCG.
- Specificity/Cross-Reactivity: "The addition of hLH (300 mIU/ml), hFSH (1000 mIU/ml), and hTSH (1000μIU/ml) to negative (0 mIU/ml hCG) and positive (25 mIU/ml hCG) urine showed no cross-reactivity." This demonstrates the device's ability to accurately identify hCG without interference from other hormones.
These tests were performed in a controlled laboratory setting to ascertain the device's technical specifications.
7. The Type of Ground Truth Used
- Analytical Ground Truth (for sensitivity and specificity): The ground truth was established by using known concentrations of hCG and interfering substances (hLH, hFSH, hTSH) in urine samples. This is a form of controlled laboratory standard.
- Clinical Ground Truth (for user comprehension/interpretation): While not explicitly detailed, the ultimate ground truth for the clinical trial would be the actual pregnancy status of the 73 female participants, likely corroborated by other clinical methods (e.g., blood tests by a healthcare provider). The study focuses, however, on the users' ability to interpret the device's output correctly against their known status, rather than the device's absolute accuracy in a vacuum.
8. The Sample Size for the Training Set
The document does not mention a specific training set. This is because the ACON™ One Step Home Pregnancy Test Strip is a chemical-based in-vitro diagnostic device, not an AI/machine learning algorithm that requires a training dataset. The development and calibration of such a device are based on biochemical principles and laboratory testing, not iterative machine learning.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for an AI/machine learning algorithm, this question is not applicable. The standardization of the test's analytical performance was against the "World Health Organization Third International Standard" for hCG, which serves as a global reference.
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K993483
JAN 2 0 2000
"Summary of Safety & Effectiveness"
ACON™ One Step Home Pregnancy Test Strip is intended for non-professional use for the identification of hCG (human chorionic gonadotropin) in urine to aid in the determination of pregnancy. The test utilizes a combination of monoclonal and polyclonal antibody reagents to selectively detect elevated levels of hCG. The assay is conducted by dipping the absorbent wick of the test in urine and observing for the formation of colored lines. The specimen migrates via capillary action along the wick and membrane to react with the colored conjugate. Positive specimens react with the specific antibody-hCG-colored conjugate and form a colored line on the Test portion of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line at the Control zone will always appear regardless of the presence or absence of hCG.
The ACON™ One Step Home Pregnancy Test Strip 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 (300 mIU/ml), hFSH (1000 mIU/ml), and hTSH (1000μIU/ml) to negative (0 mIU/ml hCG) and positive (25 mIU/ml hCG) urine showed no cross-reactivity.
Clinical trials using ACON™ One Step Home Pregnancy Test Strip were conducted which included 73 female participants. The results of the study showed that the majority of the participants found ACON™ One Step Home Pregnancy Test Strip very easy to use, and that they had no trouble understanding the labeling, reading the instructions, or interpreting the results.
The overall results of the clinical trial confirm that ACON™ One Step Home Pregnancy Test Strip is a suitable test for over-the-counter pregnancy testing.
Ana C.R. York
Nora C.R. York ACON Laboratories, Inc. 11175 Flintkote, Avenue, Suite F San Diego. CA 92121 UDA
10/12/99
Date
Premarket Notification 510(k) Number
et Notification 510(k) Number
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and head. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. The text is arranged so that it follows the curve of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 2 0 2000
Ms. Nora C.R. York Regulatory Affairs Manager Acon Laboratories, Inc. 11175 Flintkote Avenue Suite F San Diego, California 92121
K993483 Re:
Trade Name: ACON™ One Step Home Pregnancy Test Strip Regulatory Class: II Product Code: LCX Dated: December 2, 1999 Received: December 6, 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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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" (21CFR 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 Butman
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: 993483/51
Device Name: ACON™ One Step Home Pregnancy Test Strip
"Indications For Use" - ACON™ One Step Home Pregnancy Test Strip is intended for nonprofessional use for the qualitative identification of human chorionic gonadotropin (hCG) in urine to aid in the determination of pregnancy.
Dan Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K992483
(Please do not write below this point)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Or
Over-The-Counter Use
(per 21 CFR 801.109)
§ 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.