Search Results
Found 1 results
510(k) Data Aggregation
(49 days)
Immunoturbidmetric assay for the in vitro quantitative determination of apolipoprotein A-1 in human serum and plasma on automated clinical chemistry analyzers.
A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders and atherosclerosis.
A device for the measurement of human apolipoprotein A-1 in serum or plasma. Anti-apolipoprotein A-1 antibodies react with the antigen in the sample to form antigen/antibody complexes which, following agglutination, are measured turbidimetrically.
This document describes the Tina-quant Apolipoprotein A-1 ver.2 assay and its equivalence to a predicate device, but it does not detail a study with specific acceptance criteria that the device had to meet and prove. Instead, it describes a "substantial equivalence" comparison to an existing, legally marketed device.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth for test set, training set details) are not applicable or cannot be extracted from the provided text, as this type of information is typically associated with studies demonstrating performance against a defined statistical endpoint, not substantial equivalence.
Here's an analysis based on the provided text, focusing on the available information:
Description of Acceptance Criteria and the Study:
The "study" described in the provided text is a substantial equivalence comparison between the Tina-quant Apolipoprotein A-1 ver.2 assay and a predicate device (Dade Behring N Antisera to Human Apolipoprotein A-1 and Apolipoprotein B assay, K860894). The acceptance criteria for substantial equivalence are implicitly that the new device performs comparably to the predicate device across various characteristics, demonstrating similar safety and effectiveness.
The comparison focuses on:
- Intended Use and Indications for Use: Ensuring they are the same or very similar.
- Assay Protocol: Both are immunoturbidometric.
- Traceability/Standardization: The new device is standardized to IFCC reference preparation SP1-01.
- Calibration Interval: Similar.
- Performance Characteristics: Comparing precision, method comparison, hook effect, analytical sensitivity, and limitations.
The device meets the acceptance criteria by demonstrating performance characteristics that are comparable to or better than the predicate device, or within acceptable clinical ranges where direct comparison might not be feasible (e.g., analytical sensitivity).
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence claim, the "acceptance criteria" are implicitly the performance of the predicate device, and the "reported device performance" is how the new device compares. No explicit numerical acceptance criteria (e.g., "CV must be < X%") are stated, but rather a direct comparison to the predicate.
| Feature | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Tina-quant Apolipoprotein A-1 ver.2) |
|---|---|---|
| Intended Use | Immunoturbidmetric assay for in vitro quantitative determination of apolipoprotein A-1 in human serum with Behring nephelometers. | Immunoturbidmetric assay for in vitro quantitative determination of apolipoprotein A-1 in human serum and plasma on automated clinical chemistry analyzers. (Adds plasma, specific analyzers) |
| Indication for Use | For quantitative determination of apolipoprotein A-1 in serum and plasma. Used in diagnosis/treatment of lipid disorders and atherosclerosis. | For quantitative determination of apolipoprotein A-1 in serum and plasma. Used in diagnosis/treatment of lipid disorders and atherosclerosis. (Identical) |
| Assay Protocol | Immunoturbidometric | Immunoturbidometric (Identical) |
| Traceability / Standardization | Not provided in insert | Standardized with regard to the IFCC reference preparation SP1-01. (New device provides this, predicate did not specify) |
| Calibration Interval | • After each lot• as required by QC procedures | • After each lot• as required by QC procedures (Identical) |
| Sample Type | Serum | Serum and plasma (heparin, EDTA) (Expanded sample type) |
| Reagent Stability | • Store at 2-8°C, unopened.• Use within 4 weeks (if vials stopped, capped, stored at 2-8°C) or 5 days (if on nephelometer for 8 hrs/daily).• Do not freeze. | • Store at 2-8°C, unopened.• 42 days opened and refrigerated on analyzer. (Improved opened stability) |
| Calibrator | N Apolipoprotein Standard Serum (human) | C.f.a.s. Lipids (Different calibrator) |
| Controls | Apolipoprotein Control Serum CHD (human) | Precinorm L, Precipath L (Different controls) |
| Expected Values | Females: 1.25 - 2.15 g/LMales: 1.10-2.05 g/L | Females: 108 - 225 mg/dLMales: 104 - 202 mg/dL (Values provided in different units, but generally comparable ranges) |
| Instrument | Dade Behring Nephelometers | Roche/Hitachi Clinical Chemistry Analyzers (Different, specific to new device) |
| Measuring Range | Not provided in insert | 20 - 400 mg/dL (Provided for new device) |
| Precision | Inter-assay Precision: 2.2% CV @ 1.58 g/LIntra-assay Precision: 5.7% CV @ 1.45 g/L | Within run CV:1.0% @ 40 mg/dL (serum)0.6% @ 176 mg/dL (serum)1.0% @ 157 mg/dL (control)1.2% @ 83 mg/dL (control)Between Day CV:2.4% @ 47 mg/dL (serum)1.6% @ 179 mg/dL (serum)1.2% @ 171 mg/dL (control)2.4% @ 84 mg/dL (control) (Comparable or better) |
| Method Comparison | Y (BN) = 1.0 (RID) – 0.04 g/Lr = 0.98. (Compared to radioimmunodiffusion) | Y (Tina-quant) = 2.45 + 1.073X (Nephelometric method)r = 0.781 (Compared to a nephelometric method, correlation lower but context not fully provided for equivalency analysis) |
| Hook Effect | NA | No effect up to 600 mg/dL (Provided, predicate did not specify) |
| Analytical Sensitivity | Established by the lower limit of the reference curve (depends on N Apolipoprotein Standard Serum). | 0.6 mg/dL (Specific value provided for new device) |
| Limitations | Turbidity and particles can interfere. High triglycerides/lipemia may disturb Apo B assay (can retest in higher dilution). | Icterus: No significant interference up to I index of 60 mg/dL.Hemolysis: No significant interference up to H index of 1000.Lipemia: No significant interference up to L index of 1000.No cross-reactivity with Apo B or A-II. (Detailed interference studies) |
Regarding items that cannot be extracted or are not applicable for this type of submission:
- Sample size used for the test set and the data provenance: Not explicitly stated. The method comparison data implies a comparison using patient samples, but the number of samples or their origin is not specified. It's typical for method comparison studies to use a range of patient samples.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a quantitative assay, not an interpretation task requiring expert consensus. The "ground truth" would be the measurement from another validated method.
- Adjudication method for the test set: Not applicable for a quantitative assay comparison.
- 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 a laboratory diagnostic assay, not an imaging interpretation device involving human readers or AI assistance.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device itself is a standalone in-vitro diagnostic device (an "algorithm" in a sense, as it performs a quantitative measurement). Its performance is evaluated purely based on its analytical characteristics.
- The type of ground truth used: For the method comparison, the "ground truth" for the new device was a "Nephelometric method". For the predicate, it was "radioimmunodiffusion (RID)". For other performance characteristics (precision, sensitivity), "ground truth" is established through standardized reference materials and internal quality control.
- The sample size for the training set: Not applicable. This is a laboratory reagent, not a machine learning algorithm that requires a "training set" in the conventional sense. Its performance is characterized through typical analytical validation studies.
- How the ground truth for the training set was established: Not applicable. (See point 8).
In summary, the provided text details a comparison of analytical performance characteristics to establish substantial equivalence, rather than a clinical study against predefined acceptance criteria for a new clinical endpoint.
Ask a specific question about this device
Page 1 of 1