(43 days)
The SYNCHRON Systems Alkaline Phosphatase (ALP) Reagent, in conjunction with SYNCHRON Enzyme Validator Set, is intended for the quantitative determination of alkaline phosphatase activity in human serum or plasma on SYNCHRON Systems. Use of this product, in conjunction with the SYNCHRON Enzyme Validator Set, will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) or the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).
The SYNCHRON Systems Cholinesterase (CHE) Reagent, in conjunction with SYNCHRON Enzyme Validator Set, is intended for the quantitative determination of pseudo-cholinesterase activity in human serum or plasma on SYNCHRON Systems. Use of this product, in conjunction with the SYNCHRON Enzyme Validator Set, will result in assay values which are compatible with those from methods recommended by the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).
The SYNCHRON Systems ~- Glutamyl Transferase (GGT) Reagent, in conjunction with SYNCHRON Enzyme Validator Set, is intended for the quantitative determination of yglutamyl transferase activity in human serum or plasma on SYNCHRON Systems. Use of this product, in conjunction with the SYNCHRON Enzyme Validator Set, will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) and the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).
The SYNCHRON Systems Lactate Dehydrogenase (L.D) Reagent, in conjunction with SYNCHRON Enzyme Validator Set, is intended for the quantitative determination of lactate dehydrogenase activity in human serum or plasma on SYNCHRON Systems. Use of this product, in conjunction with the SYNCHRON Enzyme Validator Set, will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) and the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).
The SYNCHRON Enzyme Validator Set, in conjunction with specified enzyme assays on Beckman SYNCHRON Systems, is intended to provide points of reference in the measurement of selected human enzymes. Use of this product will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) and the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).
The SYNCHRON Systems ALP. CHE, GGT, and LD Reagents are intended for use on Beckman's SYNCHRON Clinical Systems. These reagents may be used in conjunction with the SYNCHRON Enzyme Validator for assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) or the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).
The provided document describes the SYNCHRON Systems Enzyme Reagents (ALP, CHE, GGT, LD) and the SYNCHRON Enzyme Validator Set, intended for quantitative determination of enzyme activity in human serum or plasma. It focuses on demonstrating substantial equivalence to predicate devices already on the market.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a numerical or categorical format with specific thresholds for performance. Instead, it demonstrates performance through method comparison and imprecision studies, aiming to show equivalence to existing methods (predicate devices and IFCC/DGKCh recommended methods).
The "acceptance criteria" can be inferred from the goal of demonstrating substantial equivalence, meaning the performance should be comparable to the predicate devices and recognized clinical chemistry methods.
| Assessment Metric | SynCHRON LX System Calibrated (IFCC/DGKCh) ALP Reagent | SYNCHRON LX System Calibrated CHE Reagent | SYNCHRON LX System Calibrated GGT Reagent | SYNCHRON LX System Calibrated LD Reagent |
|---|---|---|---|---|
| Method Comparison (vs. Uncalibrated Predicate) | ||||
| Slope | 1.426 (DGKCh), 1.019 (IFCC) | 0.760 | 1.141 | 1.242 |
| Intercept | 3.34 (DGKCh), -1.95 (IFCC) | 2.56 | -2.18 | -0.20 |
| Correlation Coefficient (r) | 0.999 (DGKCh), 0.999 (IFCC) | 0.999 | 0.999 | 0.996 |
| Imprecision (Total CV%) | ||||
| Level 1: 5.66% | Level 1: 1.9% | Level 1: 16.01% | Level 1: 4.5% | |
| Level 2: 2.10% | Level 2: 1.5% | Level 2: 2.19% | Level 2: 1.3% | |
| Level 3: 1.10% | Level 3: 1.8% | Level 3: 2.13% | N/A | |
| Stability | ||||
| 18 month shelf-life (for Validator) | 18 month shelf-life (for Validator) | 18 month shelf-life (for Validator) | 18 month shelf-life (for Validator) |
It's important to note that the document does not explicitly define acceptable ranges for slope, intercept, or correlation coefficient, nor for imprecision. The reported values are presented as evidence of performance.
2. Sample Sizes Used for the Test Set and Data Provenance:
- Test Set Sample Sizes (Method Comparison):
- SYNCHRON LX System Calibrated (DGKCh) ALP Reagent: n = 67
- SYNCHRON LX System Calibrated (IFCC) ALP Reagent: n = 79
- SYNCHRON LX System Calibrated CHE Reagent: n = 72
- SYNCHRON LX System Calibrated GGT Reagent: n = 79
- SYNCHRON LX System Calibrated LD Reagent: n = 70
- Test Set Sample Sizes (Imprecision): For each reagent (ALP, CHE, GGT, LD) and each level (1-3, or 1-2 for LD), "N" is consistently 80 for both within-run and total imprecision measurements.
- Data Provenance: The document does not explicitly state the country of origin of the data. Given Beckman Instruments, Inc. is located in Brea, California, USA, and the submission is to the FDA, it is highly probable the data was generated in the USA. The study design appears to be prospective for the performance testing of the new reagents and validator set, as it involves generating new data for method comparison and imprecision.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable to this type of device. The ground truth for quantitative enzyme assays is established through established analytical methods and reference materials, not through expert human interpretation or consensus. The comparison is made against existing, validated laboratory methods (predicate devices and IFCC/DGKCh recommended methods).
4. Adjudication Method for the Test Set:
This information is not applicable to this type of device. Adjudication typically refers to resolving discrepancies between human readers or between an AI and human readers, which is not relevant for quantitative chemical assays.
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:
This information is not applicable to this device. An MRMC study is relevant for diagnostic imaging or similar interpretation tasks involving human readers, not for automated quantitative enzyme reagent systems. There is no "human reader" involved in the direct output of these reagents, nor is an AI component being evaluated in conjunction with human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The studies presented (method comparison and imprecision) inherently represent standalone performance of the reagent system on the SYNCHRON Clinical Systems. The results generated are direct measurements by the automated system—there is no human-in-the-loop component for result generation, only for operating the instrument and interpreting the final quantitative values.
7. The Type of Ground Truth Used:
The "ground truth" for the test set is established by:
- Comparison to predicate devices: The uncalibrated SYNCHRON Systems Enzyme Reagents, which are already marketed and accepted.
- Compatibility with methods recommended by the International Federation of Clinical Chemistry (IFCC) or the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh): These are internationally recognized standard methods for clinical enzyme determination. The new device, when used with the Enzyme Validator, aims to produce results compatible with these reference methods.
In essence, the ground truth is based on established and recognized analytical methods and their results.
8. The Sample Size for the Training Set:
The document does not report a "training set" sample size. This is a 510(k) submission for in-vitro diagnostic (IVD) reagents, which at the time (1997) did not typically involve "training sets" in the context of machine learning or AI models. The development and validation of such reagents rely on analytical studies to establish performance characteristics rather than training data for an algorithm.
9. How the Ground Truth for the Training Set was Established:
As there is no "training set" in the context of AI/ML, this question is not applicable. The methods for developing and validating these reagents would have involved extensive R&D, formulation optimization, and initial analytical testing to ensure chemical stability, reactivity, and specificity, leading to the performance demonstrated in the summary. The "ground truth" for method development would be based on fundamental principles of analytical chemistry and biochemistry.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.