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510(k) Data Aggregation
(575 days)
NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS
The NMR LipoProfile® -2 test, used with the NMR Profiler, an automated NMR spectrometer, measures lipoprotein particles to quantify LDL particle number (LDL-P), HDL cholesterol (HDL-C), and triglycerides in serum and plasma using nuclear magnetic resonance (NMR) spectroscopy. LDL-P and these NMR-derived concentrations of triglycerides and HDL-C are used in conjunction with other lipid measurements and clinical evaluation to aid in the management of lipoprotein disorders associated with cardiovascular disease. This test is performed and provided as a service by LipoScience Laboratory.
The NMR LipoProfile Test involves measurement of the 400 MHz proton NMR spectrum of a plasma or serum sample, deconvolution of the composite signal at ~0.8 ppm to produce the signal amplitudes of the lipoprotein subclasses that contribute to the composite plasma signal, and conversion of these subclass signal amplitudes to lipoprotein subclass concentrations. The 0.8 ppm plasma NMR signal arises from the methyl group protons of the lipids carried in the VLDL, and HDL subclasses of varying diameter. The NMR signals from the various lipoprotein subclasses have unique and distinctive frequencies and lineshapes, each of which are accounted for in the deconvolution analysis model. Each subclass signal amplitude is proportional to the number of subclass particles emitting the signal, which enables subclass particle concentrations to be calculated from the subclass signal amplitudes derived from the spectral deconvolution analysis. LDL subclass particle concentrations, in units of nanomoles of particles per liter (nmol/L), are summed to give the reported total LDL particle concentration (LDL-P). By employing conversion factors that assume that the various lipoprotein subclass particles have cholesterol and triglyceride contents characteristic of normolipidemic individuals, HDL cholesterol and triglyceride concentrations are also derived.
AI Device Acceptance Criteria and Study Summary
Here's an analysis of the provided text regarding the NMR LipoProfile-2 Assay and NMR Profiler Instrument Test System:
1. Acceptance Criteria and Reported Device Performance
The document describes several analytical and clinical performance aspects. While explicit "acceptance criteria" for all metrics are not always stated with numerical thresholds, they are implied through the performance data and comparisons to predicate devices. For analytical sensitivity and linearity, specific ranges are provided.
Table 1: Acceptance Criteria (Implied/Stated) and Reported Device Performance
| Metric | Acceptance Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Analytical Sensitivity: | Acceptable precision and accuracy with total error ≤20%. | |
| - LDL-P (LOQ) | - | 300 nmol/L |
| - HDL-C (LOQ) | - | 10 mg/dL |
| - Triglycerides (LOQ) | - | 25 mg/dL |
| Assay Precision: | Acceptable intra-assay and inter-assay variability. (No explicit numeric criteria stated, but low CVs are implied as acceptable) | |
| - LDL-P (Intra-assay) | Pool 1: Mean 2222 nmol/L, SD 49.1, %CV 2.2; Pool 2: Mean 1042 nmol/L, SD 47.7, %CV 4.6 | |
| - LDL-P (Inter-assay) | Pool 1: Mean 1925 nmol/L, SD 66.7, %CV 3.5; Pool 2: Mean 1053 nmol/L, SD 68.4, %CV 6.5 | |
| - HDL-C (Intra-assay) | Pool 1: Mean 41 mg/dL, SD 0.54, %CV 1.3; Pool 2: Mean 57 mg/dL, SD 0.42, %CV 0.7 | |
| - HDL-C (Inter-assay) | Pool 1: Mean 42 mg/dL, SD 1.17, %CV 2.8; Pool 2: Mean 56 mg/dL, SD 0.83, %CV 1.5 | |
| - Trig (Intra-assay) | Pool 1: Mean 189 mg/dL, SD 2.0, %CV 1.1; Pool 2: Mean 75 mg/dL, SD 1.2, %CV 1.5 | |
| - Trig (Inter-assay) | Pool 1: Mean 219 mg/dL, SD 2.9, %CV 1.3; Pool 2: Mean 80 mg/dL, SD 1.7, %CV 2.1 | |
| Linearity: | Wide varying target concentrations with acceptable percent bias. | |
| - LDL-P (Linear Range) | - | 300-6000 nmol/L |
| - HDL-C (Linear Range) | - | 7-160 mg/dL |
| - Triglycerides (Linear Range) | - | 5-2700 mg/dL |
| Reportable Range: | - | |
| - LDL-P | - | 300 - 3500 nmol/L |
| - HDL-C | - | 7 - 140 mg/dL |
| - Triglycerides | - | 5 - 1100 mg/dL |
| Interfering Substances: | No appreciable interference at clinically relevant concentrations. | No appreciable interference by Endogenous substances (Bilirubin, Creatinine, Hemoglobin, Urea, Uric acid) or Exogenous substances (Acetaminophen, Aspirin, Clopidogrel, Enalapril, Fenofibrate, Furosemide, Glipizide, Hydralazine, Hydrochlorothiazide, Ibuprofen, Isosorbide dinitrate, Metformin, Metoprolol, Naproxen, Niacin, Nifedipine, Piroxicam, Simvastatin, Thiazolidinedione, Triamterene) at tested concentrations. The concentrations tested were representative of the highest blood concentrations expected for the highest therapeutic doses of these compounds. |
| Method Comparison (HDL-C): | Demonstrate substantial equivalence to a predicate chemistry analyzer system. (Implicit: strong correlation and similar mean values.) | 5,362 plasma samples tested. R-squared = 0.897. NMR LipoProfile mean: 50.7 mg/dL; Predicate mean: 51.3 mg/dL. |
| Method Comparison (Triglycerides): | Demonstrate substantial equivalence to a predicate chemistry analyzer system. (Implicit: strong correlation and similar mean values.) | 5,362 plasma samples tested. R-squared = 0.929. NMR LipoProfile mean: 128.7 mg/dL; Predicate mean: 123.9 mg/dL. |
| Clinical Performance (LDL-P): | Statistically significant relationship to CVD risk, aiding in the management of lipoprotein disorders. (Implicit: demonstrating predictive value for cardiovascular events). | VA-HIT Study (Baseline): Odds Ratio 1.31 (95% CI, 1.09-1.57), p=0.004 for a new CHD event with 1-SD increment of LDL-P in placebo group. EPIC-Norfolk Study (Multivariable): Statistically significant association of LDL-P quartiles with incident CAD events (p=0.02, highest quartile HR 1.37 (1.04-1.83)). Women's Health Study: Statistically significant association of LDL-P quintiles with incident CVD events (p |
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