(103 days)
The DSL I-hCG IRMA assay is intended for the quantitative determination of I-hCG in human serum. It is intended for in vitro diagnostic use by professional laboratory personnel as an aid in the detection of pregnancy.
The IRMA format is a non-competitive assay in which the analyte to be measured is "sandwiched" between two antibodies. The first antibody is immobilized to the inside wall of the test tube, the other antibody is radiolabelled for detection. The analyte present is bound by both the antibodies to form a "sandwiched" complex. Unbound materials are removed be decanting and washing the tubes. The resultant is analyzed in a gamma counter for bounds counts per minute. The amount of bound hCG is directly proportional to the concentration of the hCG present in the sample.
The provided text is a summary of safety and effectiveness for a diagnostic device, the DSL 8300 I-hCG IRMA Kit. This document describes the device's purpose and a study conducted to demonstrate its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria or study details in the format requested for AI/medical imaging device assessment.
The information provided is more aligned with the regulatory submission for a traditional in-vitro diagnostic test kit (Radioimmunoassay in this case) from 1996, focusing on analytical performance and comparison to a legally marketed predicate. Therefore, many of the requested categories, which are standard for modern AI/ML medical device studies, are not applicable or cannot be extracted from this text.
Here's the closest possible interpretation and extraction of information based on the provided text, with clear indications where information is not available or not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance |
|---|---|
| Premarket Equivalence (Implied): Performance should be substantially equivalent to the DPC hCG IRMA predicate device to support marketing. This is not a quantitative pre-defined threshold like sensitivity/specificity. | Linear Regression Analysis: Y = 0.86(X) + 9.5 |
| Correlation Coefficient (r): 0.96 |
Explanation of "Acceptance Criteria" for this Device:
In the context of a 1996 510(k) submission for an in-vitro diagnostic, the "acceptance criteria" isn't typically specified as a quantitative performance metric like sensitivity or specificity. Instead, the primary "acceptance criterion" for clearance is demonstrating substantial equivalence to a predicate device. This is achieved by showing that the new device is as safe and effective as a legally marketed device. The methods chosen (patient sample comparison and linear regression) are designed to support this claim. A correlation coefficient of 0.96 and a regression equation close to Y=X would support substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): n = 53 patient samples
- Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: Not specified, but "patient samples... were collected and assayed using both methods" suggests prospective collection for the study purpose, or at least a concurrent assaying of samples on both devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable / Not Provided. For an assay measuring a quantitative analyte like hCG, the "ground truth" is typically the measured value itself, often cross-referenced or calibrated against a reference standard, not a subjective interpretation by experts. The comparison here is against another diagnostic device's quantitative output.
4. Adjudication Method for the Test Set
- None. This concept is not applicable as the study involves a direct comparison of quantitative measurements from two different assay kits, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This type of study (MRMC) is typically performed for imaging or qualitative diagnostic devices where human readers interpret results. The DSL I-hCG IRMA Kit is a quantitative laboratory assay.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. This is a standalone diagnostic kit. Its performance is evaluated intrinsically through its analytical capabilities and comparison to a predicate, not with human-in-the-loop interaction in the AI sense. The "algorithm" for this device is the immunoassay procedure itself and the gamma counter's measurement.
7. The Type of Ground Truth Used
- Comparison to a Predicate Device's Measurement: The "ground truth" for the test samples in this specific study appears to be the measurements obtained from the DPC hCG IRMA, which serves as the reference standard for establishing substantial equivalence. It's not pathology, expert consensus, or outcomes data in the usual sense.
8. The Sample Size for the Training Set
- Not Applicable / Not Provided. This device is an immunoassay kit, not an AI/ML model that undergoes a "training phase." Its development involves reagent formulation, assay optimization, and calibration, not machine learning training on a dataset.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. See point 8. The concept of "ground truth for a training set" does not apply to this type of traditional diagnostic assay development.
§ 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.