(67 days)
The DPC IMMULITE 2500 analyzer is an automated immunoassay system intended to assay the same broad range of analytes in patient samples as does IMMULITE 2000. The intent of the system is to impart the same automation to the same array of immunoassays in the same hospital and commercial laboratory settings as IMMULITE 2000. Examples of the array of assays to be used with the DPC IMMULITE 2500 are two for which data in support of a claim of substantial equivalence have been submitted to FDA: hCG (product code: DHA) and TSH (JLW). The system is intended to produce safe and effective performance when used by medical laboratory personnel as is the predicate system, IMMULITE 2000.
The IMMULITE® 2500 is an Automated Immunoassay Analyzer. It is a discrete photometric chemistry analyzer for clinical use intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. The IMMULITE 2500 uses ¼ inch polystyrene antibody coated beads and assay specific antibody or antigen labeled with alkaline phosphatase. The chemiluminescent detection system is a phosphate ester stabilized dioxetane. Cleavage of the phosphate ester by alkaline phosphatase results in the decomposition of the dioxetane and the emission of photons, which are quantified by a luminometer and are proportional to the quantity of analyte present.
The IMMULITE® 2500 Automated Immunoassay Analyzer is an automated immunoassay system that intends to assay the same broad range of analytes in patient samples as the IMMULITE 2000. The device is intended to provide the same automation to the same array of immunoassays in the same hospital and commercial laboratory settings as the IMMULITE 2000.
The 510(k) summary only mentions two analytes for which data was submitted to FDA in support of a claim of substantial equivalence: hCG (human chorionic gonadotropin) and TSH (thyroid-stimulating hormone). However, it does not explicitly state the acceptance criteria for these tests nor does it provide a table of performance data. The FDA's substantial equivalence determination letter refers to "indications for use stated in the enclosure" but this enclosure is not provided in the document.
Therefore, specific acceptance criteria and detailed device performance data are not available in the provided text.
Based on the limited information available:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the text. The document refers to "data in support of a claim of substantial equivalence have been submitted to FDA" for hCG and TSH, but the acceptance criteria and the actual performance data (e.g., sensitivity, specificity, accuracy, precision) are not detailed within the provided summary or the FDA letter.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as this is an in-vitro diagnostic device measuring analytes, not relying on expert interpretation of images or clinical findings for ground truth in the typical sense. The ground truth for analytical performance would typically be established by reference methods or gravimetric methods for controls and calibrators, and clinical outcome for patient samples. However, no details on how "ground truth" was established for the comparison studies are provided.
4. Adjudication method for the test set:
Not applicable for an in-vitro diagnostic device like this, which assesses analytical performance rather than diagnostic interpretation requiring adjudication.
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:
Not applicable. This is an automated immunoassay analyzer, not a device requiring human readers or AI assistance in interpretation. The comparison is between the performance of the IMMULITE 2500 and its predicate device, IMMULITE 2000, in terms of analytical output.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the IMMULITE 2500 is an automated immunoassay system, implying standalone performance. The intent is "to impart the same automation to the same array of immunoassays" as its predicate, the IMMULITE 2000, with "safe and effective performance when used by medical laboratory personnel." This indicates a standalone performance study against the predicate device.
7. The type of ground truth used:
While not explicitly stated, for an immunoassay analyzer, the "ground truth" for demonstrating substantial equivalence would typically involve:
- Reference methods: Comparing results from the IMMULITE 2500 to established, validated reference methods for measuring hCG and TSH.
- Comparison to predicate device: Direct comparison of results from patient samples and control materials analyzed on the IMMULITE 2500 against those analyzed on the IMMULITE 2000 (the predicate device). This would involve assessing correlation, bias, and agreement.
- Known concentrations: Using control materials with known concentrations of analytes to verify accuracy and precision.
8. The sample size for the training set:
Not applicable. This device is an immunoassay analyzer and does not utilize a "training set" in the context of machine learning. Its performance is based on its established biochemical and detection technology.
9. How the ground truth for the training set was established:
Not applicable, as there is no "training set" for this type of device.
§ 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.