(93 days)
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: |
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.