(327 days)
The S-Test Total Bilirubin Reagent is intended for the quantitative determination of bilirubin in serum or heparin plasma using the S40 Clinical Analyzer. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The S-Test Blood Urea Nitrogen Reagent is intended for the quantitative determination of urea nitrogen in serum or heparin plasma using the S40 Clinical Analyzer. Measurements of Urea Nitrogen are used in the diagnosis and treatment of certain renal and metabolic diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The S-Test Glucose Reagent is intended for the quantitative determination of glucose in serum or heparin plasma using the S40 Clinical Analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The S40 Clinical Analyzer is an automatic wet chemistry system intended for use in clinical laboratories or physician office laboratories that consists of a desktop analyzer, an operation screen that prompts the user for operation input and displays data, a unit cover, and disposable reagent cartridges. The desktop analyzer includes a single pipettor, an incubation rotor, and a multi-wavelength photometer. The analyzer can measure analytes in serum, heparin plasma, whole blood, and urine.
Once the sample is placed into the device, the analyzer pipettes the sample, pipettes the reagent, and mixes the sample and reagent together. After the sample and reagent react in the incubator bath, the analyzer measures the absorbance of the sample, and based on the absorbance, it calculates the concentration of analyte in the sample.
The S-Test total bilirubin (BIL) reagent cartridge used with the S40 Clinical Analyzer is intended for quantitative in vitro diagnostic determination of total BIL by measuring bilirubin concentration in serum or heparin plasma based on an enzymatic photometric test measuring the formation of biliverdine from bilirubin.
The S-Test blood urea nitrogen (BUN) reagent cartridge used with the S40 Clinical Analyzer is intended for quantitative in vitro diagnostic determination of BUN in serum or heparin plasma based on an enzymatic photometric test measuring the formation of NADP from NADPH.
The S-Test glucose (GLU) reagent cartridge used with the S40 Clinical Analyzer is intended for quantitative in vitro diagnostic determination of GLU in serum or heparin plasma based on an enzymatic photometric test measuring the formation of NADPH from NADP.
The provided text describes the performance data for three S-Test reagents (BIL, BUN, GLU) used with the S40 Clinical Analyzer, as submitted in a 510(k) summary to the FDA. The information focuses on precision, accuracy, and sensitivity.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" as a pre-defined set of thresholds that the device must meet. Instead, it presents performance data (precision, accuracy, sensitivity) and then concludes that "Based on the foregoing data, the device is safe and effective. These data also indicate substantial equivalence to the predicate devices." This implies that the reported performance metrics were considered acceptable for demonstrating substantial equivalence.
Given this, the table below will present the reported device performance for each metric. The "Acceptance Criteria" column will reflect the implied criteria based on the predicates and the FDA's ultimate determination of substantial equivalence (i.e., the reported performance was accepted). Without direct numerical acceptance criteria, the "Acceptance Criteria" will be a qualitative statement reflecting the goal of achieving performance comparable to predicate devices and being considered safe and effective.
| Test Parameter | Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| S-Test BIL | Precision | Comparable to predicate devices; safe and effective | Within-run CV: 0.0 - 10.7%; Total CV: 0.0 - 13.3% |
| Accuracy (Correlation) | Correlation coefficient and regression analysis indicating strong agreement with a comparison method. | Correlation Coefficient: 0.996 - 0.998 | |
| Standard Error Estimate: 0.48 - 0.53 | |||
| Confidence Interval Slope: 0.926 - 1.125 | |||
| Confidence Interval Intercept: 0.00 - 0.30 | |||
| Sensitivity | Detection limit allowing for intended clinical use | Detection Limit: 0.2 mg/dL | |
| S-Test BUN | Precision | Comparable to predicate devices; safe and effective | Within-run CV: 0.7 - 2.5%; Total CV: 0.9 - 6.6% |
| Accuracy (Correlation) | Correlation coefficient and regression analysis indicating strong agreement with a comparison method. | Correlation Coefficient: 0.996 - 0.997 | |
| Standard Error Estimate: 0.9 - 1.83 | |||
| Confidence Interval Slope: 0.922 - 1.040 | |||
| Confidence Interval Intercept: -2.11 - 1.47 | |||
| Sensitivity | Detection limit allowing for intended clinical use | Detection Limit: 4.9 mg/dL | |
| S-Test GLU | Precision | Comparable to predicate devices; safe and effective | Within-run CV: 1.1 - 2.9%; Total CV: 1.3 - 6.6% |
| Accuracy (Correlation) | Correlation coefficient and regression analysis indicating strong agreement with a comparison method. | Correlation Coefficient: 0.989 - 0.998 | |
| Standard Error Estimate: 7.4 - 16.0 | |||
| Confidence Interval Slope: 0.994 - 1.133 | |||
| Confidence Interval Intercept: -17.5 - -1.87 | |||
| Sensitivity | Detection limit allowing for intended clinical use | Detection Limit: 18 mg/dL |
2. Sample Size Used for the Test Set and the Data Provenance:
- S-Test BIL: 91 samples for the main correlation study; additional "patient correlation studies" were done at three Physician Office Laboratory (POL) sites. The provenance (country of origin, retrospective/prospective) is not specified, but the use of "patient correlation studies" suggests prospective collection of clinical samples for accuracy comparisons. Precision studies were conducted over 22 days and 5 days (in-house and at POL sites) using unknown types of samples (e.g., control materials, patient samples).
- S-Test BUN: 94 samples for the main correlation study; additional "patient correlation studies" were done at four POL sites. Similar to BIL, provenance is not specified, but "patient correlation studies" suggest prospective clinical data. Precision studies were conducted over 22 days and 5 days (in-house and at POL sites).
- S-Test GLU: 97 samples for the main correlation study; additional "patient correlation studies" were done at four POL sites. Similar to BIL and BUN, provenance is not specified, but "patient correlation studies" suggest prospective clinical data. Precision studies were conducted over 22 days and 5 days (in-house and at POL sites).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
The document does not mention the use of "experts" in the context of establishing ground truth. For these types of in vitro diagnostic devices, the "ground truth" for accuracy studies is typically established by measurements from a "comparison method" (often a well-established, previously cleared or gold-standard laboratory instrument/method). The qualifications of those performing the comparison method are not specified.
4. Adjudication Method for the Test Set:
Not applicable. This device is an automated chemistry analyzer. The ground truth for accuracy studies is based on a comparison to a referent laboratory method, not on human adjudication or consensus.
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:
Not applicable. This device is an automated in vitro diagnostic instrument/reagent system, not an AI-assisted diagnostic imaging or interpretation system requiring human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the performance data presented (precision, accuracy, sensitivity) is for the device operating in a standalone manner, meaning the S40 Clinical Analyzer using the S-Test reagents without human interpretation influencing the measurement results beyond standard laboratory practices. The "accuracy" studies compare the device's measurements directly to a comparison method.
7. The Type of Ground Truth Used:
The ground truth used for the accuracy studies was established by a "comparison method", which is another established laboratory instrument or reagent system. For example, for BIL, BUN, and GLU, the S40 Clinical Analyzer's results were compared to those from an unnamed "comparison method." This is a common practice for IVD devices to demonstrate substantial equivalence to existing technologies.
8. The Sample Size for the Training Set:
The document does not explicitly mention a "training set" in the context of algorithm development, as this type of chemistry analyzer likely relies on established analytical principles rather than machine learning algorithms that require explicit training. The precision and accuracy studies are typically validation studies performed on the final device, not training.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a "training set" or explicit algorithm development (in the machine learning sense), this question is not applicable to the provided information. If there were internal method development phases, the ground truth would similarly be established by reference methods or gravimetric/volumetric standards for calibrators and controls.
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.