(65 days)
One Step urine hCG (cassette format) Pregnancy Test is for the in vitro diagnostic use --- for the detection of hCG (human Chorionic Gonadotropin) presence in female urine specimens and in turn for the early detection of pregnancy. This test kit is used (only once) to obtain a visual and qualitative results for the Over-the-Counter Use.
Urine RCG (Cassette Format) One Step Test Kit
While the provided documents confirm FDA clearance for the Urine HCG (Cassette Format) One Step Test Kit and describe its intended use, they do not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria in the format requested.
Specifically, the documents are a 510(k) clearance letter and an Indications for Use statement. These documents confirm substantial equivalence to a predicate device and outline the intended use, but they do not present the technical performance data, study design, or specific acceptance criteria in the way a scientific study report would.
Therefore, I cannot fulfill the request for information on acceptance criteria and study details based solely on the provided text.
However, based on what is typically expected for an in vitro diagnostic device like a pregnancy test and what might be inferred from such a regulatory submission, here's a general idea of what that information would look like if it were present:
Hypothetical Acceptance Criteria and Study Information (Based on typical IVDD requirements, NOT the provided document)
Since the provided document is an FDA clearance letter and an "Indications For Use" statement, it does not contain the detailed technical performance study information you are asking for. However, for a device like a pregnancy test, the following information would typically be part of the submission that led to this clearance:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Hypothetical) | Reported Device Performance (Hypothetical) |
|---|---|---|
| Sensitivity (Detection of hCG at 25 mIU/mL) | ≥ 99% | 99.5% |
| Specificity (Absence of hCG in negative samples) | ≥ 99% | 100% |
| Accuracy (Overall agreement with reference method) | ≥ 99% | 99.8% |
| Cross-Reactivity (Interference from related hormones) | ≤ 1% positive bias (LH, FSH, TSH) | No significant cross-reactivity observed |
| Hook Effect (High-dose insensitivity) | No hook effect up to 500,000 mIU/mL hCG | No hook effect up to 500,000 mIU/mL hCG |
| Expected Values (Correct identification of pregnant/non-pregnant samples) | Clinically acceptable range | Consistent with expected clinical outcomes |
| Precision (Reproducibility between runs/lots) | CV ≤ 10% | CV < 5% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Typically, hundreds to thousands of urine samples would be used for a comprehensive clinical study. For a general pregnancy test, this might involve:
- Positive samples: 100-200 confirmed pregnant urine samples (various stages of pregnancy).
- Negative samples: 200-500 confirmed non-pregnant urine samples.
- Spiked samples: A range of hCG concentrations (e.g., 0, 10, 25, 50, 100, 500,000 mIU/mL) to assess sensitivity, linearity, and hook effect.
- Data Provenance: Likely a combination of:
- Prospective collection: From clinical sites within Canada (where the manufacturer is located) and potentially the US.
- Retrospective collection: Archived samples with known hCG status, potentially from various countries if adequately characterized.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Ground Truth Determination: For clinical samples, the ground truth for hCG status is typically established by:
- Confirmation with a highly sensitive and quantitative reference laboratory method: Such as a validated immunoassay (e.g., chemiluminescent immunoassay) performed at a College of American Pathologists (CAP) accredited laboratory.
- Clinical confirmation: Including follow-up with patient medical records for pregnancy confirmation (e.g., ultrasound, continued elevated hCG levels over time).
- "Experts": While individual "experts" don't typically "read" the ground truth for every sample, the ground truth is overseen by:
- Board-certified Clinical Pathologists or Clinical Biochemists: Supervising the reference laboratory testing. (e.g., Clinical Biochemist with 10+ years of experience, similar to Dr. David Lee's qualifications).
- Clinical Obstetricians/Gynecologists: Providing clinical correlation for patient outcomes.
4. Adjudication Method for the Test Set
- Not applicable in the typical sense for a quantitative ground truth. Adjudication (e.g., 2+1) is more common when human readers are involved in interpreting images or subjective results.
- For a quantitative ground truth (like a reference immunoassay), the result itself is the "adjudicated" truth, usually with established cut-off values. Discrepancies between the investigational device and the reference method would be resolved by re-testing (e.g., re-running both tests on an aliquot, using a third confirmatory method).
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
- Highly Unlikely for this device. This is a standalone diagnostic kit with a visual, qualitative result (a line appearing or not appearing). There are no "human readers" interpreting complex images or data that AI would assist with in this context. MRMC studies are typical for imaging AI, not for a simple in vitro diagnostic test like a pregnancy strip.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, this is a standalone device. The performance claimed (sensitivity, specificity, accuracy) is inherently the "standalone" performance of the test kit itself, without a human interpretation component that could be "assisted" or compared to. The user simply observes the line/no line.
7. The Type of Ground Truth Used
- Reference Laboratory Assay + Clinical Outcomes: The primary ground truth would be established by a highly sensitive and quantitative laboratory hCG assay, combined with clinical correlation like ultrasound confirmation or longitudinal hCG observation to confirm pregnancy status.
8. The Sample Size for the Training Set
- Not applicable in the traditional "AI training set" sense. This device is a biochemical assay (lateral flow immunoassay), not an AI algorithm that undergoes machine learning training. The "training" for such a device involves iterative development and optimization of the reagents and strip components. The "test set" described above serves as the validation for the final product.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8. The "ground truth" during development involves ensuring the assay correctly detects hCG at specific concentrations and does not cross-react with other substances, which is done through laboratory experiments using purified hCG and known interferents, not through a "training set" of patient data in the AI sense.
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Food and Drug Administration 098 Gaither Road Rockville MD 20850
JAN 0 3 2003
Dr. David Lee. MCIC, FCACB Director, Regulatory Affairs IND Diagnostic Inc. 1629 Fosters Way Delta. B.C. CANADA V3M 6S7
K023638 Re:
Trade/Device Name: Urine RCG (Cassette Format) One Step Test Kit Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: November 25, 2002 Received: December 10, 2002
Dear Dr. Lee:
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 (OS) 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). Other general information on your responsibilities under the Act may be obtained 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,
Steven Sutman
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Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Device Name: Urine HCG (Cassette format)
One Step Test Kit
Indications For Use:
One Step urine hCG (cassette format) Pregnancy Test
is for the in vitro diagnostic use --- for the detection of hCG (human Chorionic Gonadotropin) presence in female urine specimens and in turn for the early detection of pregnancy.
This test kit is used (only once) to obtain a visual and qualitative results for the Over-the-Counter Use.
Oilll
Dr. David Lee, MCIC, FCACB, Certified Clinical Biochemist.
October 31, 2002
Director,
Regulatory Affairs,
IND Diagnostic Inc.,
1629 Fosters Way, Delta, B. C.,
CANADA V3M 6S7
email davidlee@ind.ca
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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.