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510(k) Data Aggregation
Immunoassay for the in vitro quantitative determination of cardiac troponin T (cTnT) in lithium heparin plasma. The immunoassay is intended to aid in the diagnosis of myocardial infarction. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas system analyzers. CalSet Troponin T Gen 5 STAT is used for calibrating the quantitative Elecsys Troponin T Gen 5 STAT immunoassay on the cobas system analyzers. PreciControl Troponin is used for quality control of the Elecsys Troponin I and Elecsys Troponin I STAT immunoassays on the Elecsys and cobas e immunoassay analyzers. PreciControl Troponin is also used for quality control of the Elecsys Troponin T Gen 5 STAT immunoassay on the cobas system analyzers. The Elecsys Troponin T Gen 5 CalCheck 5 is an assayed control for use in the calibration verification and for use in the verification of the assay range established by the Elecsys Troponin T Gen 5 reagent on the cobas system analyzers.
(1) The Elecsys Troponin T Gen 5 STAT Immunoassay is a two-step sandwich immunoassay on the cobas e 411analyzer and a one-step process on the cobas e 601 analyzer. The assay uses streptavidin-coated.
This document describes the analytical and clinical performance of the Elecsys Troponin T Gen 5 STAT Assay and its associated calibrators and quality controls. It demonstrates the device's substantial equivalence to previously marketed devices.
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied by the "Results" sections showing that the device's performance metrics either
- met specific numerical targets (e.g., CV% for precision, ng/L for LoQ), or
- were within a defined percentage recovery or range (e.g., ±10% for interferences, 90-110% for control recovery, 80-120% for CalCheck recovery).
Here’s a table summarizing the performance based on the provided text, where acceptance criteria are explicitly stated or clearly implied by the successful results.
| Performance Characteristic | Acceptance Criteria (Explicit or Implied) | Reported Device Performance (Elecsys TnT Gen 5 STAT) |
|---|---|---|
| Precision | CLSI Guideline EP5-A2 met. Accuracy goal: CV of 10% (Intermediate Precision). LoQ: CV of 20% (Intermediate Precision). | Precision met goals on both cobas e 411 and cobas e 601. |
| Troponin T value at 10% CV | CV of 10% achievable as per CLSI EP17-A2. | cobas e 411: 10.4 ng/L (Lot 170511), 6.70 ng/L (Lot 173678) at 10% CV. cobas e 601: 4.76 ng/L (Lot 170511), 3.85 ng/L (Lot 173678) at 10% CV. |
| Limit of Quantitation (LoQ) | 20% CV (intermediate precision) at ≤ 6 ng/L. | cobas e 411: 5.5 ng/L (Lot 170511), 3.6 ng/L (Lot 173678) at 20% CV. cobas e 601: 2.5 ng/L (Lot 170511), 2.0 ng/L (Lot 173678) at 20% CV. LoQ labeled as 6 ng/L. |
| Linearity | For cobas e 411, deviation from linearity not more than 6.3%. For cobas e 601, deviation from linearity not more than 12.4%. | Linearity confirmed in the overall range from 3.19 ng/L to 10,439 ng/L (meets specifications set by the study data). Labeled range: 6 – 10000 ng/L. |
| High Dose Hook Effect | Not explicitly stated as a numerical criterion, but "No hook effect was seen". | No hook effect seen up to 100,000 ng/L. |
| Endogenous Interferences | Recoveries within ± 10% of values in samples not containing interferents. | Met for Bilirubin, Biotin, Lipemia, Rheumatoid Factors, Hemoglobin, Human Serum Albumin, Cholesterol (up to specified concentrations). |
| HAMA Interference | Not explicitly stated as a numerical criterion for acceptance, but "Interference of approximately 10% was seen with HAMA concentrations > 322 µg/L" is reported. | Interference of approximately 10% seen with HAMA concentrations > 322 µg/L. |
| Analytical Specificity/Cross Reactivity | Recoveries within ± 10% of values in samples not containing cross-reactants. | Met for Skeletal muscle TnT, Skeletal muscle TnI, Cardiac TnI, Human TnC (up to specified concentrations). |
| Exogenous Interference (Drugs) | Recoveries within ± 10% of values in samples not containing the drugs. | Met for 16 common pharmaceutical compounds and 18 cardiac drugs (up to specified concentrations). |
| Sample Stability | All stressed samples recovered within ± 10% of fresh samples. | Stable for 24 hours at 2-8 °C, 12 months at -20 °C (±5°C). Freeze only once. |
| Calibration Stability (Onboard) | 7 days. | 8 days. |
| Calibration Stability (Lot) | 12 weeks. | 13 weeks. |
| Reagent Stability (First Opening) | 12 weeks. | 13 weeks. |
| Reagent Stability (On-board) | 4 weeks. | 5 weeks. |
| Reagent Stability (Stress) | 3 weeks. | 3 weeks. |
| Reagent Stability (Shelf Life) | Not explicitly stated beyond "n/a", but aiming for 18 months. | 19 months. (Claimed shelf life: 18 months) |
| Elecsys Troponin T CalSet: Stability | Concentrations 14 ng/L: Recovery 100 ± 10%. | On board stability: up to 5 hours at 20-25°C. At 2-8°C: 4 days. At -20°C (±5°C): 3 months. |
| Elecsys PreciControl Troponin: Real-Time Stability | PreciControl Troponin 1: 90-110%. PreciControl Troponin 2: 90-110%. | Shelf life claim: 18 months. |
| Elecsys PreciControl Troponin: Reconstitution | Recovery 74-126% for PC Troponin 1, 81-119% for PC Troponin 2 (vs. 60 min). | Data supports complete reconstitution after 60 minutes. |
| Troponin T Gen 5 CalCheck 5: Open-Vial Stability | CalCheck Level 1: ≤ 6 ng/L. L2-5: 90-110% recovery of reference value. | Stable up to 4 hours at 20-25°C. |
| Troponin T Gen 5 CalCheck 5: Real-Time Stability | CalCheck Level 1: |
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