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510(k) Data Aggregation
(30 days)
ELECSYS RBC FOLATE HEMOLYZED REAGENT
Elecsys RBC Folate Hemolyzing Reagent is used together with the Elecsys Folate II assay for the quantitative determination of folate in erythrocytes (RBC folate).
Binding assay for the in vitro quantitative determination of folate in human serum. Measurements obtained by this devices are used in the diagnosis and treatment of anemias.
The binding assay is intended for use on the Roche Elecsys 2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers.
The Elecsys RBC Folate Hemolyzing Reagent is an ascorbic acid solution with which whole blood treated with anticoagulants (heparin or EDTA) is diluted. After incubation the erythrocytes are lysed and intracellular folate is liberated and stabilized. The hemolysate is then used as a prediluted sample for subsequent measurement in the Elecsys Folate II assay.
The provided document describes the Elecsys RBC Folate Hemolyzing Reagent. However, it does not include detailed acceptance criteria or a study designed to explicitly prove the device meets specific acceptance criteria in the way a diagnostic accuracy or comparative effectiveness study would.
Instead, this 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Elecsys Red Blood Cell Folate Lysing Reagent, K981931). The "Device Comparison" table highlights similarities and differences, implying that the modified device's performance characteristics (like precision and stability) are considered acceptable by being comparable to or improved over the predicate.
Given the information provided, I will construct a response based on the comparisons made in the document rather than a formal acceptance criteria study.
Here's an analysis based on the provided text, addressing your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the format of a clinical trial's pre-defined thresholds for success. Instead, the performance is reported as a comparison to a predicate device, implying that the modified device's performance is deemed acceptable if it is similar to or improved over the predicate.
| Performance Metric | Predicate Device (Elecsys Red Blood Cell Folate Lysing Reagent, K981931) | Modified Device (Elecsys RBC Folate Hemolyzing Reagent) | Implied "Acceptance" |
|---|---|---|---|
| Intended Use | Quantitative determination of folate in human red blood cells. | Same (Quantitative determination of folate in erythrocytes [RBC folate]). | Same, ensuring clinical utility is maintained. |
| Test Principle | Competitive chemiluminescence | Same | No change in underlying analytical methodology. |
| Sample Type | Whole blood, heparinized or EDTA | Same | Compatibility with standard blood collection methods. |
| Sample / Lysing | 1:31 | Same | Consistent sample preparation protocol. |
| Reagent Ratio | |||
| Measuring Range | Not provided | Up to 1407 nmol/L (620 ng/mL) without considering hematocrit. | The modified device provides a specified measuring range, which implies it's within clinically relevant levels. |
| Pretreatment Incubation | 90 minutes ± 15 | Same | Consistent workflow and stability during sample preparation. |
| Stability - Ascorbic Acid | 7 days | 14 days | Improvement: Extended stability simplifies usage and potentially reduces waste. |
| Stability - Whole blood at room temp | 4 hours, 1 day (additional text unclear, potentially referring to refrigerated) | 2 hours (room temp), Same (for 1 day, likely refrigerated interpretation). | Potential change: Room temperature stability for whole blood is 2 hours, compared to 4 hours. This is a functional difference to note. |
| Stability - Hemolysate at room temp | Not recommended | 3.5 hours | Improvement: Hemolysate stability at room temperature adds flexibility for sample handling. |
| Expected Values | N=111, 342 - 786 ng/ml | (US) N=105, 342 - 786 ng/ml; (Europe) N=282, 176 - 589 ng/ml. | Reference ranges are established for different populations, consistent with clinical practice. |
| Precision (2010 Analyzer) | 6.5% CV @ 469 ng/ml; 4.8% CV @ 850 ng/ml | 6.8% CV @ 478 ng/ml; 6.6% CV @ 573 ng/ml; 5.5% CV @ 623 ng/ml. | Comparable precision at different concentrations, demonstrating analytical reliability. |
| Precision (E170 Analyzer) | Not applicable (not tested or reported for predicate) | 9.5% CV @ 188 ng/ml; 6.1% CV @ 312 ng/ml; 3.6% CV @ 410 ng/ml. | Demonstrates performance on an additional analyzer, expanding utility. |
Study to Prove Acceptance Criteria:
The document describes a substantial equivalence comparison study rather than a study designed to meet specific acceptance criteria for a novel device. The goal was to show the new "Elecsys RBC Folate Hemolyzing Reagent" is as safe and effective as the previously cleared "Elecsys Red Blood Cell Folate Lysing Reagent (K981931)".
2. Sample Size Used for the Test Set and Data Provenance
- Expected Values:
- US Population: N=105
- European Population: N=282
- Precision (2010 Analyzer): N=63 (Whole blood)
- Precision (E170 Analyzer): N/A (Number of samples for E170 precision is not explicitly stated, only resultant CVs across multiple concentrations.)
- Data Provenance: Not explicitly stated, but the mention of both "US" and "Europe" for expected values suggests multinational data collection. The study is implicitly retrospective, as it compares the new device's performance to existing predicate data and uses samples to generate new performance characteristics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This type of information is not applicable to this submission. The device is a diagnostic assay for measuring folate levels. "Ground truth" in this context would refer to the true folate concentration in a sample, which is determined by the analytical method itself or by a reference method. It does not involve expert interpretation or consensus in the way an imaging or pathology study would.
4. Adjudication Method for the Test Set
Not applicable. See point 3.
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 device is a laboratory reagent, not an AI-assisted diagnostic tool that involves human readers/interpreters.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The "standalone" performance for such an assay refers to its analytical performance characteristics (like precision, accuracy, measuring range, stability). These are precisely what are reported in the comparison table, such as:
- Measuring range of up to 1407 nmol/L.
- Precision (CV%) values on both Elecsys 2010 and E170 analyzers.
- Stability data for ascorbic acid, whole blood, and hemolysate.
These are intrinsic analytical characteristics of the device itself.
7. The Type of Ground Truth Used
For folate assays, "ground truth" typically means the established, measured concentration of folate in a sample. This is not "expert consensus," "pathology," or "outcomes data." It's based on analytical measurement compared to a known standard or a reference method. The "expected values" are derived from healthy populations (reference ranges) rather than an individual "ground truth" for each sample.
8. The Sample Size for the Training Set
Not applicable. This device is an immunoassay reagent, not a machine learning or AI-based algorithm that requires a "training set" in the computational sense. The data presented are for performance validation.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
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