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510(k) Data Aggregation
(265 days)
ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY
For the in vitro quantitative determination of degradation products of type I collagen in human serum and plasma, for assessing individual bone resorption. The test may be used as an aid in monitoring anti-resorptive therapies (e.g. bisphosphonates, hormone replacement therapy - HRT) in postmenopausal women and individuals diagnosed with osteopenia. The elecrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche ELECSYS 1010 and 2010 immunoassay analyzers.
The ELECSYS® β-CrossLaps/serum Test is based on a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2-point calibration and a master curve provided with the reagent bar code card.
This document describes a 510(k) submission for the ELECSYS® β-CrossLaps/serum Immunoassay, seeking substantial equivalence to a predicate device. It does not contain a study proving the device meets specific acceptance criteria in the traditional sense of a clinical trial with pre-defined performance thresholds for accuracy, sensitivity, or specificity against a ground truth.
Instead, the submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device (Osteometer Serum CrossLaps™ One Step ELISA) by comparing various performance characteristics. The acceptance criteria are implicitly defined by the comparable performance of the predicate device.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria (Implicit) and Reported Device Performance
Since this is a substantial equivalence claim, the "acceptance criteria" are the performance characteristics of the predicate device, and "reported device performance" is the performance of the ELECSYS® β-CrossLaps/serum Immunoassay.
| Feature | Acceptance Criteria (Predicate Device) | Reported Device Performance (ELECSYS® β-CrossLaps/serum Immunoassay) |
|---|---|---|
| Within-Run Precision (%CV) | Serum samples: | Human sera: |
| 5.4% at 1737 pM | 4.6% at 0.08 ng/mL | |
| 5.0% at 2694 pM | 1.8% at 0.39 ng/mL | |
| 5.1% at 3415 pM | 1.0% at 3.59 ng/mL | |
| Controls: | ||
| 3.4% at 0.15 ng/mL | ||
| 1.6% at 0.84 ng/mL | ||
| 2.2% at 3.18 ng/mL | ||
| Total Precision (%CV) | Serum samples: | Human sera: |
| 8.1% at 1963 pM | 4.7% at 0.08 ng/mL | |
| 5.4% at 2820 pM | 4.3% at 0.39 ng/mL | |
| 6.5% at 3503 pM | 1.6% at 3.59 ng/mL | |
| Controls: | ||
| 3.4% at 0.15 ng/mL | ||
| 1.9% at 0.84 ng/mL | ||
| 2.5% at 3.18 ng/mL | ||
| Analytical Sensitivity | 94 pM | 0.01 ng/mL |
| Interferences | No interference from ditaurobiliribin up to 60 mg/dL | No interference from bilirubin up to 65 mg/dL |
| No interference from hemoglobin up to 1.0 g/dL | No interference from hemoglobin up to 0.5 g/dL | |
| No interference from intralipid up to 1000 mg/dL | No interference from intralipid up to 1500 mg/dL | |
| No interference from biotin up to 90 ng/mL | ||
| No interference from rheumatoid factor up to 1500 U/mL | ||
| No high dose hook effect up to 150 ng/mL | ||
| Measuring Range | 94 – 20,000 pM | 0.010 – 6.00 ng/mL |
| Assay Protocol | 1-step sandwich assay | 2-step sandwich assay |
| Detection Protocol | ELISA/Absorbance reading | Electrochemiluminescence |
| Instrument | Microtiter Plate Reader | ELECSYS® 2010 and 1010 Immunoassay Analyzers |
| Procedure | Manual | Automatic |
| Calibration Frequency | Calibration with each run | ELECSYS® 2010: after 1 month (same lot), after 7 days (same kit). ELECSYS® 1010: with every reagent kit, after 7 days (20-25°C), after 3 days (25-32°C). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the total sample size used for the performance characteristic studies (e.g., precision, analytical sensitivity, interference).
- Precision: "Human sera" and "Controls" are mentioned, implying multiple samples were tested at different concentrations. Specific numbers are not provided.
- Interference: Various substances were tested for interference, but the number of samples or specific experimental setup for these tests is not detailed.
The data provenance (country of origin, retrospective/prospective) is not mentioned. Given it's a submission to the FDA, it's likely the studies were conducted under good laboratory practices, but the location is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of immunoassay does not typically involve human experts establishing a "ground truth" in the same way an imaging device might. The "ground truth" for an immunoassay is typically established by:
- Reference materials/standards: The analytical sensitivity and calibration are based on purified peptides and internal reference standards.
- Clinical correlation: While the intended use includes monitoring therapies, the document primarily focuses on analytical performance. Clinical correlation studies (e.g., comparing results to patient outcomes) are not detailed here as the primary "ground truth" for the device's technical performance.
Therefore, this question is not directly applicable to the type of device and study described.
4. Adjudication Method for the Test Set
Not applicable. This is an immunoassay, and measurements are quantitative. There's no human interpretation or subjective assessment of results that would require an adjudication method.
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 in vitro diagnostic immunoassay, not an AI-assisted diagnostic imaging device for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Yes, the performance characteristics (precision, analytical sensitivity, interference) provided are for the device (ELECSYS® β-CrossLaps/serum Immunoassay) operating in a standalone mode on the ELECSYS 1010 and 2010 immunoassay analyzers, without human-in-the-loop performance influencing the measurement itself. Humans operate the machines and interpret the results, but the analytical performance data are intrinsic to the device.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for an immunoassay's analytical performance (as presented here) relies on:
- Reference standards/Calibrators: Purified peptide standards are used for calibration and traceability. These are the fundamental "ground truth" for achieving accurate quantitative measurements.
- Validated measurement methods: The performance characteristics are measured against established laboratory practices and often using validated control materials.
For the intended use of "assessing individual bone resorption" and "monitoring anti-resorptive therapies," the ultimate ground truth would involve clinical factors like bone mineral density (BMD) changes, fracture rates, or other clinical outcomes. However, this submission focuses on the analytical equivalence of the assay itself, not a full clinical outcome study.
8. The Sample Size for the Training Set
Not applicable. This device is an immunoassay, not a machine learning or AI algorithm that requires a "training set" in the conventional sense of developing a model. The "training" for such a device involves establishing calibration curves and optimizing manufacturing processes, which utilizes internal quality control and validation data rather than a distinct "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for an algorithm in this context. The "ground truth" for the device's operational parameters (e.g., calibration curve) is established using validated controls and reference materials with known concentrations of the analyte (degradation products of type I collagen).
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