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510(k) Data Aggregation
(49 days)
2001
Re: K013249
Trade/Device Name: Tina-quant Apolipoprotein A-1 ver.2 Regulation Number: 21 CFR 866.5580
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.
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(45 days)
0457
Re: K013278
Trade/Device Name: Tina-quant Apolipoprotein A-1 ver.2 Regulation Number: 21 CFR 866.5580
In vitro diagnostic reagent system intended for use on COBAS INTEGRA system for the quantitative immunological determination of human apolipoprotein A-1 in serum and plasma.
For the quantitative determination of apolipoprotein A-1 in serum and plasma. 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.
Human apolipoprotein A-1 forms a precipitate with a specific antiserum which is determined turbidimetrically at 340 nm.
The provided text describes the regulatory submission for the Tina-quant Apolipoprotein A-1 ver.2 Assay, claiming substantial equivalence to a previously marketed device (COBAS Integra Tina-quant Apolipoprotein A-1, K990594). While it details performance characteristics of the new device and compares them to the predicate, it does not explicitly state "acceptance criteria" as a set of predefined thresholds. Instead, the submission demonstrates that the new device's performance is comparable to or better than the predicate device across various metrics, thus implicitly meeting an "acceptance criteria" of being substantially equivalent.
Here's an attempt to extract and interpret the information based on the typical structure of such submissions, acknowledging that explicit "acceptance criteria" might not be numerically stated but rather inferred through comparison to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
Since explicit "acceptance criteria" are not listed, the table below will present the performance characteristics of the new device (Tina-quant Apolipoprotein A-1 ver.2) and the predicate device as a basis for comparison, implying that the Tina-quant Apolipoprotein A-1 ver.2's performance is considered "acceptable" because it is comparable to or improved over the legally marketed predicate.
| Feature | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (Tina-quant Apolipoprotein A-1 ver.2) |
|---|---|---|
| Precision | ||
| Within run CV | ≤1.5% @ 0.68 g/L; ≤1.0% @ 2.7 g/L | 1.0% @ 0.88 g/L; 0.8% @ 1.64 g/L (Improved) |
| Between Day CV | ≤1.2% @ 0.68g/L; ≤0.78% @ 2.7 g/L | 2.4% @ 0.88 g/L; 1.7% @ 1.64 g/L (Higher for low values, higher for high values) |
| Method Comparison | Correlation coefficient (r) indicative of strong agreement (Predicate: r = 0.993) | y = 0.87x + 0.25 g/L; r = 0.940 (Good, but slightly lower correlation than predicate) |
| Prozone Effect | >5.8 g/L | >6 g/L (Improved) |
| Analytical Sensitivity (LDL) | 0.37 g/L (37mg/dL) | 0.058 g/L (5.8 mg/dL) (Significantly improved/lower detection limit) |
| Limitations (Interference) | No significant interference from Icterus, Hemolysis, Lipemia, Rheumatoid factors | No significant interference from Icterus, Hemolysis, Lipemia (up to 1000 mg/dL Intralipid), Rheumatoid factors (Comparable) |
| Reagent Stability (On-board) | 12 weeks | 4 weeks (Lower than predicate) |
| Measuring Range (with rerun) | 0.12 - 5.6 g/L | 0.10 - 4.0 g/L (Lower upper limit, comparable lower limit) |
Summary of Acceptance: The device is accepted on the basis of "substantial equivalence" to the predicate. The performance data for the Tina-quant Apolipoprotein A-1 ver.2 shows areas of improvement (e.g., precision within run, prozone effect, analytical sensitivity) and areas of minor differences (e.g., between-day CV, reagent stability, measuring range, method correlation) that are deemed acceptable for the intended use.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). Studies for precision typically use multiple replicates over several days with control materials, while method comparison studies involve a number of patient samples. The values provided for "Method Comparison" (y = 0.87x + 0.25 g/L, r = 0.940) suggest a linear regression analysis, which would require a set of patient samples, but the number is not disclosed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (number and qualifications of experts) is typically relevant for diagnostic imaging or subjective interpretation devices. For an in vitro diagnostic (IVD) reagent system like the Tina-quant Apolipoprotein A-1 ver.2, the "ground truth" for the test set values would be established through laboratory reference methods or certified reference materials, rather than expert interpretation. Therefore, this question is not directly applicable in the context of this device.
4. Adjudication Method for the Test Set
As the "ground truth" for this IVD device is based on quantitative measurements and reference methods, not subjective interpretation, no adjudication method (like 2+1 or 3+1 by experts) would be applicable or required.
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
A Multi-Reader Multi-Case (MRMC) study is typically performed for devices that involve human interpretation of images alongside an AI algorithm. The Tina-quant Apolipoprotein A-1 ver.2 is an in vitro diagnostic (IVD) reagent system that automates the quantitative immunological determination of apolipoprotein A-1 in serum and plasma, not an AI-assisted diagnostic imaging device. Therefore, an MRMC study was not performed, and thus, there is no effect size related to human readers improving with AI assistance. This question is not applicable to the described device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the performance characteristics provided (Precision, Method Comparison, Prozone Effect, Analytical Sensitivity, Limitations) are all reflective of the standalone performance of the Tina-quant Apolipoprotein A-1 ver.2 reagent system operating on the COBAS Integra Clinical Chemistry Analyzers. There is no human interpretation or intervention in the measurement process beyond standard laboratory operating procedures and maintenance.
7. The Type of Ground Truth Used
The ground truth used for evaluating the performance characteristics would be:
- Certified Reference Materials/Control Materials: For precision and analytical sensitivity, the device's measurements are compared against known concentrations in control materials.
- Validated Reference Methods: For method comparison, the device's results are compared against results obtained from a predicate device or a well-established, commercially available system, which would themselves be validated against reference methods. While "pathology" or "outcomes data" are not directly used as ground truth for this device's performance, the clinical utility of Apolipoprotein A-1 measurements is linked to "diagnosis and treatment of lipid disorders and atherosclerosis," implying that the measurements are expected to correlate with relevant clinical states.
8. The Sample Size for the Training Set
The document describes a reagent system and its performance characteristics rather than a machine learning model that requires a "training set." Therefore, the concept of a "training set" in the context of AI/ML is not applicable here. The development of such a system involves empirical testing and optimization but not in the same way as training a neural network.
9. How the Ground Truth for the Training Set was Established
As explained above, the concept of a "training set" in the AI/ML sense is not relevant for this device. The development of such an IVD system involves extensive analytical method development, optimization, and validation using various samples (e.g., patient samples, spiked samples, control materials) to ensure accuracy, precision, and robustness. The "ground truth" during this development would be established through highly accurate reference methods or known concentrations in prepared samples.
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