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510(k) Data Aggregation
(78 days)
DIAGNOSTIC PRODUCTS CORPORATION
The IMMULITE® IMMULITE® 1000 High Sensitivity CRP assay is intended for use as follows: For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 Analyzer for the quantitative measurement of C-Reactive protein (CRP) in serum or plasma as an aid in the detection and evaluation of infection, tissue injury and inflammatory disorders, and associated diseases. Measurements may also be used as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP (hsCRP) measurements when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndrome may be useful as an independent marker for recurrent events in patients with stable coronary disease or acute coronary syndrome.
IMMULITE® 2000 High Sensitivity CRP assay is intended for use as follows: For in vitro diagnostic use with the IMMULITE 2000 Analyzer - for the quantitative measurement of C-Reactive protein (CRP) in serum or plasma as an aid in the detection and evaluation of infection, tissue injury and inflammatory disorders, and associated diseases. Measurements may also be used as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP (hsCRP) measurements when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndrome may be useful as an independent marker for recurrent events in patients with stable coronary disease or acute coronary syndrome.
The IMMULITE/IMMULITE 1000 and IMMULITE 2000 High Sensitivity CRP is a solid-phase, chemiluminescent immunometric assay. The assay utilizes a 14-inch polystyrene bead coated with anti-ligand. The bead is co-incubated with sample, murine monoclonal anti-CRP, and alkaline phosphatase (bovine calf intestine)-conjugated to rabbit polyclonal anti-CRP in buffer for 30 minutes on each IMMULITE/IMMULITE 1000 and IMMULITE 2000 platform. Unbound enzyme conjugate is removed by a centrifugal wash procedure. Substrate is added and the resulting chemiluminescence is read in the luminometer.
The IMMULITE®/IMMULITE® 1000 and IMMULITE® 2000 High Sensitivity CRP assays are immunological test systems designed for the quantitative measurement of C-Reactive protein (CRP) in serum or plasma. These devices are intended to aid in the detection and evaluation of infection, tissue injury, inflammatory disorders, associated diseases, and in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP measurements, when used with traditional clinical evaluations of acute coronary syndrome, may also serve as an independent marker for recurrent events in patients with stable coronary disease or acute coronary syndrome.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (from predicate/literature) | IMMULITE/IMMULITE 1000 Performance (Reported) | IMMULITE 2000 Performance (Reported) |
|---|---|---|---|
| Working Range | Predicate: 0.175 to 1100 mg/L | 0.3 to 100 mg/L | 0.2 to 100 mg/L |
| Analytical Sensitivity | Predicate: 0.175 mg/L | 0.1 mg/L | 0.1 mg/L |
| Functional Sensitivity | Not reported in predicate | 0.3 mg/L (at 10% CV) | 0.2 mg/L (at 10% CV) |
| Precision (Intra-assay CV%) | Predicate not explicitly stated for specific levels. Literature-based expectations for CRP assays. | Did not exceed 6.0% (0.3-78 mg/L) | Did not exceed 8.7% (0.23-93.7 mg/L) |
| Precision (Inter-assay CV%) | Predicate not explicitly stated for specific levels. Literature-based expectations for CRP assays. | Not greater than 7.5% (0.8 mg/L), 6% (1.5 mg/L), 4.8% (3.1 mg/L), 4.9% (15.0 mg/L). Did not exceed 10% (0.3-78 mg/L). | Not greater than 7.1% (0.85 mg/L), 3.1% (3.2 mg/L), 3.3% (12.3 mg/L). Did not exceed 8.7% (0.23-93.7 mg/L). |
| Linearity | Demonstrated | Demonstrated within precision of the assay | Demonstrated within precision of the assay |
| Spiked Recovery | Demonstrated | Demonstrated within precision of the assay | Demonstrated within precision of the assay |
| Interference (Bilirubin) | Predicate: No significant interference up to 230 mg/L | No effect up to 200 mg/L | No effect up to 200 mg/L |
| Interference (Hemoglobin) | Predicate: No significant interference up to 36 g/L (36000 mg/L) | No effect up to 570 mg/L | No effect up to 512 mg/L |
| Interference (Triglycerides) | Predicate: No significant interference up to 7.4 g/L (7400 mg/L) | No effect up to 3000 mg/L | No effect up to 3000 mg/L |
| Cross-Reactivity | Not specified for predicate | No cross-reactivity (HSA, IgG, Transferrin) | No cross-reactivity (HSA, IgG, Transferrin) |
| High Dose Hook Effect | Not reported in predicate | No hook effect up to 3780 mg/L | No hook effect up to 3780 mg/L |
| Method Comparison (Regression) | Substantial equivalence to predicate (slope ~1, intercept ~0, r > 0.95 generally for IVDs) | IMMULITE/IMMULITE 1000 vs. Dade Behring HSCRP: | |
| Full range (N=175): slope = 0.952, intercept = 0.022, r = 0.996 |
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DIAGNOSTIC PRODUCTS CORPORATION
The IMMULITE 2500 Vitamin B12 assay is for in vitro diagnostic use with the IMMULITE 2500 Analyzer — for the quantitative measurement of vitamin B12 in serum or heparinized plasma, as an aid in clinical diagnosis and treatment of anemia.
The IMMULITE 2500 Folic Acid is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of folic acid in serum, heparinized plasma or ascorbic acid-treated whole blood, as an aid in clinical diagnosis and treatment of anemia.
IMMULITE 2500 Vitamin B12 is a solid-phase, two-site chemiluminescent enzyme immunoassay for use with the IMMULITE 2500 Automated Analyzer.
IMMULITE 2500 Folic Acid is a solid-phase, two-site chemiluminescent enzyme immunoassay for use with the IMMULITE 2500 Automated Analyzer.
The provided text is a 510(k) summary for the IMMULITE 2500 Vitamin B12 and IMMULITE 2500 Folic Acid assay. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive de novo clinical study data with specific acceptance criteria and detailed performance statistics as might be found in a PMA submission or a full clinical study report.
Therefore, the document does not contain the detailed information required to fill out all sections of your request. Specifically, it lacks:
- Explicit acceptance criteria: While the claim of "substantial equivalence" implies that performance is comparable to the predicate, specific quantitative acceptance criteria for each analytical performance parameter are not listed.
- Detailed study results (test set sample size, provenance, ground truth establishment, expert details, adjudication methods, MRMC studies, standalone performance): The summary states the conclusion of substantial equivalence based on information presented in the Special 510(k), but it doesn't provide the raw data, study design, or methodology for how that equivalence was demonstrated in terms of clinical performance or specific analytical studies for new aspects of the device. Special 510(k)s often refer to changes that do not affect the intended use or fundamental scientific technology, relying on previous data and analytical verification.
- Training set details: Information on a separate training set is not present as this is typically required for AI/ML device submissions, which this is not.
Based on the information available:
1. A table of acceptance criteria and the reported device performance:
This information is not explicitly provided in the given 510(k) summary. The document focuses on demonstrating substantial equivalence to a predicate device (IMMULITE 2000 Vitamin B12 and IMMULITE 2000 Folic Acid), implying that its performance is critically comparable to that predicate. Specific numerical acceptance criteria and detailed performance results of verification and validation studies are not included in this summary document. Performance data would typically be found in the manufacturer's internal validation reports, which are not publicly available in this summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the given 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable as this device is an in-vitro diagnostic test for quantitative measurement of biomarkers, not an imaging device requiring expert interpretation for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as this device is an in-vitro diagnostic test.
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 information is not applicable. This device is an in-vitro diagnostic test, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable in the context of an "algorithm only" performance for an IVD test in the same way it would be for an AI/ML device. The device's performance is intrinsically standalone as it quantitatively measures a biomarker. The summary implies the device's analytical performance (accuracy, precision, linearity, etc.) was assessed, but details are not provided here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For an in-vitro diagnostic device like IMMULITE 2500 Vitamin B12, the "ground truth" would typically refer to the true concentration of Vitamin B12 in a sample. This "ground truth" is usually established through:
- Reference Methods: Comparison against established, highly accurate reference methods, often involving mass spectrometry or validated laboratory methods.
- Certified Reference Materials: Using materials with known, accurately assigned concentrations of the analyte.
- Spiked Samples: Samples artificially augmented with known amounts of the analyte.
The specific methods used to establish this "ground truth" for the performance studies are not detailed in this 510(k) summary.
8. The sample size for the training set:
This information is not provided/not applicable for this type of IVD device in the context of AI/ML training data.
9. How the ground truth for the training set was established:
This information is not provided/not applicable for this type of IVD device in the context of AI/ML training data.
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(46 days)
DIAGNOSTIC PRODUCTS CORPORATION
For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers - for the quantitative measurement of intact parathyroid hormone (parathyrin, PTH) in EDTA plasma or serum. It is intended as an aid in the differential diagnosis of hypercalcemia and hypocalcemia and can be used intraoperatively.
IMMULITE/IMMULITE 1000 Turbo Intact PTH is a solid-phase, chemiluminescent immunometric assay employing a goat polyclonal anti-PTH (44-84) antibody as the capture antibody and a goat polyclonal anti-PTH (1-34) antibody conjugated to alkaline phosphatase as the detection antibody.
Here's an analysis of the IMMULITE®/IMMULITE® 1000 Turbo Intact PTH device's acceptance criteria and the supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Used as a benchmark for intraoperative utility) | Reported Device Performance |
|---|---|
| Criterion 1: 50% or greater decrease from baseline PTH value suggests complete tumor removal. | Mayo Clinic Study: 45 out of 47 patients (96%) had their plasma intact PTH (iPTH) levels decrease to 50% decrease in iPTH values. |
| Criterion 2: Return to normal iPTH values after parathyroid tissue is removed (indicating clinical cure). | Mayo Clinic Study: This occurred in 87% of patients, and all of them were clinically cured. |
| Criterion 3: Samples suitable for intraoperative monitoring (rapid results). | Mayo Clinic Study: Collection of blood samples was stopped at 10 minutes (2 patients) and 15 minutes (2 patients), suggesting results were available quickly enough for intraoperative decisions. |
| Criterion 4: Comparable physiological outcomes (normocalcemia postoperatively) when using intraoperative PTH vs. traditional methods. | Washington University Study: 44/49 (90%) of the study group (with intraoperative PTH) and 49/55 (89%) of the control group achieved normocalcemia postoperatively. This indicates identical physiological outcomes. |
| Criterion 5: Reduced reliance on frozen section use with intraoperative PTH. | Washington University Study: Frozen section use in the study group was statistically significantly less (p |
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