(35 days)
For in vitro diagnostic use with the CARESIDE Analyzer™ to measure amylase from whole blood, serum or plasma specimens to aid in the diagnosis and treatment of patients with disease of the pancreas, salivary gland, and kidney.
CARESIDE™ Amylase cartridges are used with the CARESIDE Analyzer™ to measure amylase activity in whole blood, serum or plasma specimens. The CARESIDE™ Amylase cartridge, a single use disposable in vitro diagnostic test cartridge, delivers a measured volume of serum or plasma to a dry film to initiate the measurement of amylase activity. The film cartridge (patent pending) contains all reagents necessary to measure amylase activity.
Each CARESIDE™ Amylase cartridge consists of an amylase-specific multi-layer reagent film mounted in a plastic base with a hinged lid. The user introduces the specimen into the cartridge Sample Well, closes the lid and inserts the cartridge into the CARESIDE Analyzer™.
Once loaded, the CARESIDE Analyzer™ scans the cartridge barcode, brings the cartridge and the contained specimen to 37℃, and spins the cartridge to move the sample from the Sample Well into the cartridge channels and chambers. 8.5 microliters of sample remains in the metering passage. Any excess sample flows into an overflow well.
The 8.5 microliters of sample is automatically dispensed onto the multi-layer reagent film. The spreading and substrate layer distributes the specimen uniformly. Amylase converts p-nitrophenyl-α-D-maltopentaoside (PNP-Gm) to p-nitrophenyl-oligosaccharides and free oligosaccharides (Gn). The sample mixture diffuses into the underlying detection layer where PNP-Gm is converted by a-glucosidase to generate Gm and p-nitrophenol which converts to a vellow dye. The color intensity of the resulting yellow dye, as measured by the amount of reflected light at 425 nanometers, directly relates to the amylase activity of the specimen.
As the cartridges spin. a photodiode measures reflectance of light emitted by a wavelength-specific light emitting diode (LED) over a fixed time period. The analyzer uses the reflectance measurements and the lot-specific standard curve to calculate amylase activity.
Here's an analysis of the provided text regarding the CARESIDE™ Amylase device, structured to answer your questions:
Acceptance Criteria and Device Performance Study for CARESIDE™ Amylase
This document describes the 510(k) submission (K990025) for the CARESIDE™ Amylase device, seeking substantial equivalence to a predicate device. The information focuses on the device's technical characteristics and comparative performance.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state "acceptance criteria" in a numerical or target format. Instead, it presents Comparative Performance Characteristics with the predicate device, Vitros AMYL DT Slides. The implied acceptance criteria are that the CARESIDE™ Amylase performs "as well as or better than" the predicate device in these areas, demonstrating "substantial equivalence."
| Characteristic | Implied Acceptance Criteria (relative to Predicate) | CARESIDE™ Amylase Performance | Vitros AMYL DT Slides Performance |
|---|---|---|---|
| Detection Limit | As good as or better than predicate | 15 U/L | 5 U/L |
| Reportable Range | Overlap and sufficient range | 15 to 600 U/L | 5 to 900 U/L |
| Accuracy | Acceptable, ideally similar to or better than predicate | Mean recovery 95% | Not provided |
| Precision | As good as or better than predicate | Total CV, 75 U/L, 13% | Total CV, 51 U/L, 13% |
| Method Comparison | Good correlation to predicate and other methods | CARESIDE™ = 0.94 (Trace Sci. Amylase DST) + 11.5 U/L, r = 0.97 | |
| CARESIDE™ = 0.76 (Vitros AMYL DT) + 14.6 U/L, r = 0.95 | N/A (this is the predicate) | ||
| Interference | No significant interference | No significant interference observed at tested concentrations (Ascorbic Acid, Hemoglobin, Triglycerides) | No reported interference |
| Linearity | Acceptable slope and correlation coefficient | Linearity yielded slope and correlation coefficient within acceptable limits. | Not provided |
Note: The document explicitly states: "The nonclinical and clinical data provided demonstrate that the CARESIDE™ Amylase product is as safe, effective, and performs as well as or better than the legally marketed predicate device." This general statement serves as the overarching acceptance criterion for the 510(k) submission.
2. Sample Size for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set in the comparative performance characteristics section.
The data provenance (country of origin, retrospective/prospective) is also not explicitly stated. However, given the context of a 510(k) submission to the FDA, it is highly probable that the studies were conducted under controlled laboratory conditions, likely in the US or in a manner compliant with US regulatory standards.
3. Number of Experts and their Qualifications for Establishing Ground Truth for the Test Set
The document does not mention the use of experts to establish ground truth for the test set. In the context of in vitro diagnostic (IVD) devices like this amylase test, ground truth is typically established by reference laboratory methods, other commercially available and validated diagnostic tests, or clinical outcomes, rather than expert consensus on images or interpretations.
4. Adjudication Method for the Test Set
Given that the ground truth is established through laboratory methods and comparative studies with established devices, an "adjudication method" as typically understood in qualitative or image-based diagnostic studies (e.g., 2+1, 3+1) is not applicable and not mentioned in this document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is more relevant for diagnostic imaging devices where human readers interpret patient scans. The CARESIDE™ Amylase is an in vitro diagnostic (IVD) device that provides a quantitative measurement, not an interpretation by a human reader.
Therefore, the effect size of human readers improving with or without AI assistance is not applicable here.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
The performance characteristics presented (detection limit, reportable range, accuracy, precision, method comparison, linearity, interference) describe the standalone performance of the CARESIDE™ Amylase device. The device itself is an automated system (cartridge with analyzer) measuring amylase activity. There isn't a human-in-the-loop component for interpretation of the measurement itself; rather, a human uses the analyzer and interprets the numerical result it provides.
7. The Type of Ground Truth Used
The ground truth for the performance evaluations (accuracy, precision, method comparison) appears to be established by:
- Reference laboratory methods: "Rate determination using ethylidene-pNP-G7 substrate, spectrophotometric detection, 37 °C" is listed as a "Reference Method."
- Predicate device measurements: Comparisons were made against the Vitros AMYL DT (predicate device).
- Other commercially available methods: The method comparison also references "Trace Sci. Amylase DST."
Therefore, the ground truth is based on established, conventional, and predicate quantitative measurement methods for amylase.
8. The Sample Size for the Training Set
The document does not provide information on the sample size used for the training set. This information is typically proprietary to the manufacturer and not usually detailed in a 510(k) summary for an IVD device unless it's a novel AI/ML algorithm requiring extensive training data disclosure.
9. How the Ground Truth for the Training Set was Established
Similar to the training set sample size, the document does not describe how ground truth for a training set was established. Since this is a chemical assay, rather than an AI/ML system that "learns" from data, the concept of a "training set" in the machine learning sense of establishing ground truth isn't directly applicable in the same way. Performance characteristics are validated through testing the chemical reactions and reflectance photometry against known concentrations and reference methods. If there was internal calibration or optimization, it would involve reference solutions or materials with known amylase concentrations.
§ 862.1070 Amylase test system.
(a)
Identification. An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).(b)
Classification. Class II.