(44 days)
Artron One-Step hCG Urinary Pregnancy Test Device is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine to help in the early determination of pregnancy. The device is designed for over-the-counter use as well as professional use.
For a final diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical result.
Not Found
The provided document (K060019) is a 510(k) clearance letter for the Artron One-Step Human Chorionic Gonadotropin (hCG) Urinary Pregnancy Test Device. This type of document generally confirms substantial equivalence to a predicate device and does not contain detailed study information, acceptance criteria, or performance metrics in the format requested. The letter states that the device is "substantially equivalent" to legally marketed predicate devices.
Therefore, the requested information regarding acceptance criteria, specific study design details (sample sizes, data provenance, expert details, adjudication methods, MRMC studies, standalone performance), and ground truth establishment for this specific device's clearance study is not available within the provided text.
The document primarily focuses on the regulatory confirmation of market clearance based on substantial equivalence. It does not include the detailed performance data or study specifics that would be submitted to FDA as part of the 510(k) application itself.
However, based on the general nature of an hCG urinary pregnancy test, we can infer typical performance expectations and study types, but these are not explicitly stated in this document.
To provide a hypothetical response, assuming such information were present for a similar diagnostic device, here's how it would be structured, with placeholders where the specific information is missing from the provided text:
Hypothetical Response (Information Not Present in Provided Document K060019):
The provided 510(k) clearance letter (K060019) for the Artron One-Step hCG Urinary Pregnancy Test Device confirms its substantial equivalence to predicate devices but does not contain the detailed acceptance criteria and study data requested. The letter confirms the device's market clearance but does not provide the specifics of the performance studies conducted to demonstrate its efficacy.
To answer your request, information regarding acceptance criteria, sample sizes, expert qualifications, and study methodologies would typically be found in the actual 510(k) submission document accompanying this clearance letter, which is not provided here.
However, for a diagnostic device like a pregnancy test, the general types of performance studies and criteria might include:
1. Table of Acceptance Criteria and Reported Device Performance (Hypothetical):
| Metric | Acceptance Criteria (Hypothetical for hCG Test) | Reported Device Performance (Not in document) |
|---|---|---|
| Sensitivity | ≥ 99% (at 25 mIU/mL hCG concentration) | [Not provided in document] |
| Specificity | ≥ 99% (no cross-reactivity with interfering substances relevant to pregnancy testing) | [Not provided in document] |
| Accuracy | ≥ 99% agreement with a reference method | [Not provided in document] |
| Limit of Detection (LoD) | ≤ 25 mIU/mL hCG in urine | [Not provided in document] |
| Precision/Reproducibility | Consistent results across different operators/batches | [Not provided in document] |
| Interfering Substances | No significant interference from common substances (e.g., aspirin, caffeine) | [Not provided in document] |
| Hook Effect | No hook effect observed at high hCG concentrations | [Not provided in document] |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not provided in document. Typically, for in vitro diagnostic devices like pregnancy tests, a significant number of urine samples (e.g., hundreds) from pregnant and non-pregnant women would be tested.
- Data Provenance: Not provided in document. Such studies are typically prospective, using freshly collected urine samples, potentially from various clinical sites to ensure diversity. The country of origin would usually be the country where the clinical trials or performance evaluations were conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not provided in document.
- Qualifications: Not provided in document. For hCG tests, the "ground truth" is typically established by laboratory reference methods (e.g., quantitative serum hCG assays) rather than expert radiographic or clinical interpretation of the test device itself.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable in the conventional sense for a quantitative diagnostic marker like hCG in a pregnancy test. The ground truth is determined by objective laboratory measurements (e.g., quantitative serum hCG levels) and clinical confirmation (e.g., ultrasound for pregnancy). The device's result is then compared to this objective 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:
- MRMC Study: Not applicable. This device is a rapid diagnostic test for hCG, not an AI-assisted imaging device. Its interpretation is typically straightforward (presence/absence of lines) and does not involve complex human reading tasks or AI assistance in a diagnostic image sense.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, the performance of the immunoassay strip/cassette/midstream itself would be evaluated in a standalone manner against known concentrations of hCG and clinical samples. The "human-in-the-loop" component is the visual interpretation of the test result by the user, but the primary performance metrics (sensitivity, specificity, LoD) relate to the device's chemical and biological detection capabilities.
7. The type of ground truth used:
- Ground Truth Type: Most likely a combination of:
- Reference Laboratory Methods: Quantitative serum hCG assays (considered the gold standard for hCG levels).
- Clinical Confirmation: For pregnant samples, confirmed pregnancy by other clinical methods (e.g., ultrasound).
- Known hCG Spiked Samples: For analytical sensitivity and specificity, urine samples spiked with known concentrations of hCG and interfering substances.
8. The sample size for the training set:
- Training Set Sample Size: Not provided in document. Immunoassay devices typically do not have a "training set" in the machine learning sense. Instead, product development involves iterative testing and refinement using various samples until desired performance is achieved. If any calibration or algorithm tuning were involved (unlikely for a simple rapid test), samples would be used for that purpose.
9. How the ground truth for the training set was established:
- Training Set Ground Truth: Not applicable in the machine learning sense. For traditional immunoassay development, samples with known hCG concentrations (established by reference methods) are used to calibrate and optimize the test format (e.g., antibody concentrations, reagent formulation).
In summary, the provided FDA clearance letter confirms the regulatory status of the device but does not detail the technical performance studies. The requested information would typically be available in the full 510(k) submission, which is not part of this document.
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping wings, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 1 7 2006
Mr. Jerry Zheng Vice President Artron Laboratories Inc. 3938 North Fraser Way Burnaby, BC V5J 5H6 Canada
K060019 Re:
K000017
Trade/Device Name: Artron One-Step human Chorionic Gonadotropin (hCG) Urinary Pregnancy Test Device (Artron One-Step hCG strip/cassette/midtream) Regulation Number: 21 CFR §862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX, JHI Dated: December 20, 2005 Received: January 4, 2006
Dear Mr. Zheng:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of 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 encreate) to regard) to regard to the Medical Device Amendments, or to conninered pror to this 2011/17/20, in accordance with the provisions of the Federal Food, Drug, devices that have over require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, diererore, manov as 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 n may be subject to Bach adde of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA oun or loand in There announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r toase or acrisou and i termination that your device complies with other requirements of the Act that I Dr has Intactions and regulations administered by other Federal agencies. You must or any I 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).
{1}------------------------------------------------
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) I ills letter will anow you to begin mancellig of substantial equivalence of your device to a legally premarks notification: "The I DTP interlig to 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, If you desire specific mostion and advertising of your device, please contact the Office of In of questions on the promotion and Safety at (240) 276-0484. Also, please note the v Itro Diagnoution 2010 anding by reference to premarket notification" (21CFR Part 807.97). regulation entitiou, "Misoranians of your responsibilities under the Act from the I ou inay of amall 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/industry/support/index.html.
Sincerely yours,
Alberto G
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Artron One-Step Human Chorionic Gonadotropin (hCG) Urinary Pregnancy Test Device
Indications for Use 510(k) Number:
Device Name:
uman Chorionic Gonadotropin (hCG) Urinary Pregnancy Test Device
(Artron One-Step hCG strip/cassette/midstream)
Indications for Use:
Artron One-Step hCG Urinary Pregnancy Test Device is intended for the qualitative Arton One beep 100 borionic gonadotropin (hCG) in urine to help in the early determination of pregnancy. The device is designed for over-the-counter use as well as professional use.
For a final diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical result.
Image /page/2/Picture/8 description: The image shows the words "Prescription Use" followed by a blank line with an "X" on it. Below that, the text "(Part 21 CFR 801 Subpart D)" is visible. The text is in bold font.
AND/OR 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 Device Evaluation (ODE)
Ann Chappie
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K060019
§ 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.