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510(k) Data Aggregation
(67 days)
IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL
IMMULITE/IMMULITE 1000 Calcitonin: For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 Analyzer - for the quantitative measurement of calcitonin (thyrocalcitonin) in human serum, as an aid in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism.
IMMULITE 2000 Calcitonin: For in vitro diagnostic use with the IMMULITE 2000 Analyzer - for the quantitative measurement of calcitonin (thyrocalcitonin) in human serum, as an aid in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism.
IMMULITE/IMMULITE 1000 Calcitonin and IMMULITE 2000 Calcitonin are solid-phase, chemiluminescent enzyme immunoassays for use with their respective IMMULITE/IMMULITE 1000 and IMMULITE 2000 Automated Analyzers.
Here's a breakdown of the acceptance criteria and study information for the IMMULITE®/IMMULITE® 1000 Calcitonin and IMMULITE® 2000 Calcitonin devices, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for "substantial equivalence" is implicitly defined by the demonstration of comparable performance to the predicate device, Nichols Advantage™ Calcitonin. The key performance metrics presented are related to inter-assay agreement as measured by linear regression and correlation.
| Performance Metric | Acceptance Criteria (Implied) | Reported IMMULITE/IMMULITE 1000 Performance | Reported IMMULITE 2000 Performance |
|---|---|---|---|
| Linear Regression (Slope) | Close to 1.0 (indicating proportional agreement with predicate) | 0.71 | 0.81 |
| Linear Regression (Y-intercept) | Close to 0 (indicating minimal constant bias against predicate) | 4.2 pg/mL | -0.4 pg/mL |
| Correlation Coefficient (r) | Close to 1.0 (indicating strong linear relationship with predicate) | 0.990 | 0.982 |
| Mean Calcitonin Concentration | Comparable to predicate device | 155 pg/mL (IMMULITE/IMMULITE 1000) | |
| 212 pg/mL (Nichols) | 193 pg/mL (IMMULITE 2000) | ||
| 239 pg/mL (Nichols) |
2. Sample Size Used for the Test Set and Data Provenance
- IMMULITE/IMMULITE 1000 Calcitonin:
- Sample Size: 53 patient samples
- Data Provenance: Not explicitly stated (e.g., country of origin). The text refers to "patient samples," implying human origin. It does not specify if the data was retrospective or prospective.
- IMMULITE 2000 Calcitonin:
- Sample Size: 67 patient samples
- Data Provenance: Not explicitly stated (e.g., country of origin). The text refers to "patient samples," implying human origin. It does not specify if the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This study is a method comparison study between a new device and a predicate device (Nichols Advantage™ Calcitonin), not a study relying on expert-established ground truth for diagnostic classifications. The "ground truth" for each sample is the calcitonin concentration as measured by the predicate device.
4. Adjudication Method for the Test Set
Not applicable, as this is a method comparison study and not a study involving human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This study focuses on the analytical performance of a diagnostic assay, comparing its quantitative results against a legally marketed predicate device. It does not involve human readers interpreting cases or AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, this is essentially a standalone performance study. The IMMULITE/IMMULITE 1000 Calcitonin and IMMULITE 2000 Calcitonin assays are in vitro diagnostic devices that directly measure a biomarker concentration. Their performance is evaluated based on the quantitative output of the automated analyzer, without human interpretation in the loop impacting the measurement itself. The comparison is directly between the new assay's output and the predicate assay's output.
7. The Type of Ground Truth Used
The "ground truth" for the comparison is the quantitative calcitonin measurement obtained from the predicate device, the Nichols Advantage™ Calcitonin assay. This is a form of comparative ground truth against an established and legally marketed assay.
8. The Sample Size for the Training Set
The document does not provide information about a separate "training set" in the context of developing the IMMULITE Calcitonin assays. For in vitro diagnostic devices like these, method comparison studies are typically performed after the assay's development and optimization, so there isn't a "training set" in the machine learning sense. The samples used are for direct comparison/validation.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no explicitly mentioned "training set" in the context of this submission. The assays are developed based on chemical and immunological principles, and their performance is then validated against established methods.
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