(66 days)
Method: The BHCG method is an in vitro diagnostic assay for the quantitative measurement of total Beta (B) human chorionic gonadotropin: both the intact hCG dimer and the free ß subunit of human chorionic gonadotropin hormone in human serum and plasma on the Dimension Vista™ system. Measurements of B human chorionic gonadotropin are used for the early detection of pregnancy.
Calibrator: The BHCG calibrator is an in vitro diagnostic product for the calibration of the Total Beta (B) Human Chorionic Gonadotropin (BHCG) method for the Dimension Vista™ System.
Method: The BHCG method is a homogeneous, sandwich chemiluminescent immunoassay based on LOCI™ technology. The LOCTM reagents include two synthetic bead reagents and a biotinylated anti-ShCG monoclonal antibody fragment. The first bead reagent (Sensibeads) is coated with streptavidin and contains photosensitizer dye. The second bead reagent (Chemibeads) is coated with a second anti-ShCG monoclonal antibody and contains chemiluminescent dye. Sample is incubated with Chemibeads and biotinylated antibody to form a bead-BhCG-biotinylated antibody sandwich. Sensibeads are added and bind to the biotin to form bead-pair immunocomplexes. Illumination of the complex at 680 nm generates singlet oxygen from Sensibeads which diffuses to the Chemibeads and triggers a chemiluminescent reaction. The resulting chemiluminescent signal is measured at 612 nm and is directly proportional to the nicked and non-nicked free, and nicked and non-nicked intact ß human chorionic gonadotropin concentration in the sample.
Calibrator: The BHCG Calibrator is a liquid product containing human chorionic gonadotropin in a bovine calf serum matrix with stabilizers and preservative. The kit consists of twelve vials, two each of six levels containing 2.0 mL per vial for level A. 1.0 mL per vial for levels B. C. D. and E, 1.5 mL per vial for level F. Description of the manufacturing, value assignment and stability testing processes are provided.
The Dade Behring Dimension Vista™ BHCG method is an in vitro diagnostic assay used for the quantitative measurement of total Beta (B) human chorionic gonadotropin in human serum and plasma for the early detection of pregnancy. The associated calibrator is for the calibration of this method.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state "acceptance criteria" in a separate section with specific numerical targets. Instead, it compares the performance characteristics of the new device (Dimension Vista™ BHCG) to a legally marketed predicate device (Dimension® Human Chorionic Gonadotropin (HCG) method, K970387). The implication is that meeting or performing comparably to the predicate device in key analytical characteristics constitutes meeting "acceptance criteria" for substantial equivalence.
| Feature | Predicate Device (Dimension® HCG) Expected Performance (Implicit Acceptance Criteria) | Dimension Vista™ BHCG Reported Performance | Outcome |
|---|---|---|---|
| Intended Use | Quantitative measurement of intact human chorionic gonadotropin in serum and plasma for early detection of pregnancy. | Quantitative measurement of total Beta (B) human chorionic gonadotropin (intact hCG dimer and free ß subunit) in human serum and plasma for early detection of pregnancy. | Functionally similar, broader analyte measurement for new device. |
| Assay Type | Immunoassay (photometric) | Immunoassay (chemiluminescent) | Different technology, but same assay principle. |
| Sample Type | Serum and plasma | Serum and plasma | Same |
| Reportable Range | 1-1000 mIU/mL | 1-1000 mIU/mL | Same |
| Analytical Sensitivity | ≤ 1 mIU/mL | ≤ 1 mIU/mL | Same |
| Sample Volume | 40 µL | 2 µL | New device uses significantly less sample. |
Calibrator Comparison:
| Feature | Predicate Device (Dimension® HCG Calibrator) Expected Performance (Implicit Acceptance Criteria) | Dimension Vista™ βhCG Calibrator Reported Performance | Outcome |
|---|---|---|---|
| Intended Use | Calibration of HCG methods for Dimension® clinical chemistry system. | Calibration of Total Beta (β) Human Chorionic Gonadotropin method for Dimension Vista™ System. | Similar, specific to respective systems. |
| Analyte | Human urine chorionic gonadotropin | Human urine chorionic gonadotropin | Same |
| Matrix | Equine serum | Bovine calf serum | Different, but both biological matrices. |
| Form | Lyophilized, reconstituted | Liquid | Different form |
| Volume | 10 vials, 2 at each level, 2 mL reconstituted volume. | 12 vials, 2 at each level, varying volumes. | Different packaging/volumes |
| Levels | 5 levels (0, 25, 155, 522, 1120 mIU/mL) | 6 levels (0, 14, 28, 160, 550, 1100 mIU/mL) | Different range and number of levels. |
Study Proving Acceptance Criteria (Substantial Equivalence):
The device meets acceptance criteria by demonstrating substantial equivalence to the predicate device. The submission states: "mousurement of haman versin and plasma samples demonstrate good analytical and clinical agreement between the methods." This implies that studies were conducted to compare the performance of the new device against the predicate. However, specific details about these studies (e.g., number of samples, study design, statistical analysis) are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance:
The document broadly states "measurement of human serum and plasma samples" were used. However, it does not provide specific sample sizes for any test set or details regarding the country of origin of the data, or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
This section is not applicable as the document describes an in vitro diagnostic assay for quantitative measurement, not an AI or imaging device requiring expert interpretation for ground truth. The "ground truth" for quantitative assays is typically established by reference methods or validated higher-order methods, not expert consensus.
4. Adjudication Method for the Test Set:
This is not applicable for a quantitative IVD assay as described. Adjudication typically refers to resolving discrepancies between multiple expert readers, which is not relevant here.
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:
This is not applicable as the document describes an in vitro diagnostic reagent and calibrator, not an AI-assisted diagnostic tool that would involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This description is for a standalone in vitro diagnostic test system. The performance characteristics (reportable range, analytical sensitivity) are inherent to the assay itself. The comparison to the predicate device effectively serves as a standalone performance assessment relative to an established standard.
7. The Type of Ground Truth Used:
For this type of quantitative in vitro diagnostic device, the "ground truth" for comparison to a predicate device is generally established by:
- Reference Methods: Highly accurate and precise methods used to determine the true concentration of the analyte (hCG in this case).
- Validated Predicate Device Performance: The performance of the legally marketed predicate device itself, which has already been deemed safe and effective, serves as a benchmark for comparison.
The document states, "measurement of human serum and plasma samples demonstrate good analytical and clinical agreement between the methods," implying that comparisons were made to gold standard reference measurements or the established values from the predicate device.
8. The Sample Size for the Training Set:
The document does not provide specific details on any "training set" sample size. For an IVD assay like this, development typically involves method optimization and validation studies, rather than a distinct "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established:
As there is no explicit mention of a "training set" in the machine learning sense, the method of establishing its "ground truth" is not detailed in this summary. The process for developing such assays involves rigorous analytical validation, precision studies, linearity studies, interference studies, and accuracy studies against reference methods or the predicate, rather than a "ground truth" for a training set.
§ 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.