(150 days)
Diazyme DZ-Lite iFlash Total BhCG Assay is a chemiluminescent immunoassay intended for use for the quantitative determination of total beta-human chorionic gonadotro pin (total BhCG) in human serum on DZ-Lite iFlash 1800 Chemiluminiscence Immunoassay Analyzer. The assay is intended for use as an aid in the early detection of pregnancy. Diazyme DZ-Lite iFlash 1800 Chemiluminiscence Immunoassay Analyzer is used clinically in combination with the supporting chemiluminescence immunoassay reagents for determination of analytes in human body fluids through acridinium ester-based chemiluminescence method.
Diazyme DZ-Lite iFlash Total BhCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer
This particular document (K212221) is an FDA 510(k) clearance letter, which formally states that the Diazyme DZ-Lite iFlash Total BhCG Assay and Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer are "substantially equivalent" to legally marketed predicate devices.
This document itself does NOT contain the detailed study information (acceptance criteria, test results, sample sizes, ground truth establishment, etc.) that you are asking for.
Typically, this detailed information would be found in the 510(k) summary document submitted by the manufacturer to the FDA, or in the underlying scientific reports and validation studies that formed the basis for the 510(k) submission. The clearance letter only refers to the submission and acknowledges its review.
Therefore, I cannot provide the specific answers to your detailed questions based solely on the provided text. To answer your questions, I would need access to the full 510(k) submission documents, particularly the "510(k) Summary" and potentially the "Device Description" and "Performance Data" sections.
If you had the 510(k) summary, here's how I would typically extract and present the information you requested (using placeholder text where the information is missing from the current document):
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Accuracy / Correlation with Predicate | [e.g., Correlation coefficient (R) > 0.95; Bias within +/- X%] | [Specific R-value, observed bias] |
| Precision (Intra-assay CV) | [e.g., CV 0.99] | [Observed linear range and R^2] |
| Interference | [No significant interference from common substances (e.g., hemoglobin, lipids, bilirubin, common medications) at specified concentrations] | [Results indicating no significant interference at tested concentrations] |
| Cross-Reactivity | [No significant cross-reactivity with structurally similar hormones (e.g., LH, FSH, TSH) at specified concentrations] | [Results indicating negligible cross-reactivity] |
| Prozone Effect | [No prozone effect observed up to Z mIU/mL] | [Results confirming no prozone effect observed up to tested high concentrations] |
2. Sample size used for the test set and the data provenance
- Sample Size: [e.g., X number of clinical serum samples; Y number of spiked samples]
- Data Provenance: [e.g., Retrospective clinical samples collected from hospitals in the United States and Europe; Spiked samples prepared in-house; Prospective clinical samples from a multi-center study in [Country/Region]]
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: N/A (For an immunoassay like BhCG, "ground truth" is typically established by reference methods or validated laboratory methods, not expert consensus in the diagnostic imaging sense).
- Qualifications of Experts: N/A
4. Adjudication method for the test set
- Adjudication Method: N/A (Ground truth for immunoassay is typically based on a gold standard measurement method, not human adjudication of interpretations).
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: No. This device is an in vitro diagnostic (IVD) immunoassay, not an imaging AI device that assists human readers. Therefore, an MRMC study is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes. The performance data presented (e.g., accuracy, precision, LoD, linearity) is the standalone performance of the Diazyme DZ-Lite iFlash Total BhCG Assay on the Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer. The device is designed to provide a quantitative result directly.
7. The type of ground truth used
- Type of Ground Truth: For the Diazyme DZ-Lite iFlash Total BhCG Assay, the "ground truth" is established through:
- Reference Methods: Comparison of results with a legally marketed predicate device or a clinical laboratory gold standard method (e.g., another highly accurate BhCG assay, often traceably calibrated to the 1st IRP WHO standard).
- External Quality Control Materials: Samples with known concentrations.
- Spiked Samples: Negative samples to which known concentrations of BhCG are added.
- Patient Samples: Clinical samples from various populations (pregnant, non-pregnant, specific medical conditions) with BhCG levels confirmed by reference methods.
8. The sample size for the training set
- Training Set Sample Size: This is generally not applicable in the same way it is for AI/machine learning algorithms. For IVD devices, the development involves optimizing reagents and assay parameters through extensive R&D, rather than "training" an algorithm on a distinct dataset. The "training" would be part of the assay development and optimization process, not a separate, quantified "training set."
9. How the ground truth for the training set was established
- Ground Truth for Training Set: N/A (See #8 above). The assay development aims to accurately measure BhCG, and the establishment of its accuracy and other performance characteristics relies on the scientific principles of immunoassay and validation against reference materials and methods.
§ 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.