(111 days)
For in vitro diagnostic use with the CARESIDE Analyzer to quantitatively measure ALT from anti-coagulated whole blood, plasma, or serum specimens to aid in the diagnosis and treatment of patients with certain types of liver and heart disease.
CARESIDE ALT cartridges are used with the CARESIDE, Inc. CARESIDE Analyzer to measure ALT activity in anti-coagulated whole blood, plasma, or serum specimens. The CARESIDE® ALT cartridge, a single use disposable in vitro diagnostic test cartridge, delivers a measured volume of sample to a dry film to initiate the measurement of ALT activity. The patented film cartridge contains all reagents necessary to measure ALT activity.
Each CARESIDE ALT cartridge consists of an ALT-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. Approximately 8.5 microliters of sample remains in the metering passage. Any excess sample flows into an overflow well.
The sample is automatically dispensed onto the multi-layer reagent film. The spreading and substrate layer uniformly distributes the specimen. As the specimen passes through the spreading and substrate layer, ALT in the specimen catalyzes the reaction of L-aspartate and a-ketotglutaric acid to form pyruvic acid and L-glutamic acid (see Test Reaction Sequence). The pyruvic acid is converted to acetyl phosphoric acid, CO2 and hydrogen peroxide in the reaction layer. Peroxidase in the reaction layer then catalyzes the oxidation of a diaryliminidazole leuco dye by hydrogen peroxide to form a green dye. The rate of change of intensity of the color as measured by the amount of reflected light at 655 directly relates to the amount of ALT activity in the specimen.
The provided document describes the CARESIDE® ALT test system, an in vitro diagnostic device for quantitatively measuring Alanine Aminotransferase (ALT) activity. The submission is a 510(k) premarket notification, aiming to demonstrate substantial equivalence to a predicate device, not to establish new performance criteria. Therefore, the document does not contain an "acceptance criteria" table in the traditional sense of a new clinical trial setting with predefined endpoints that need to be met for device approval. Instead, it presents a comparison of the CARESIDE ALT's performance characteristics against those of the predicate device (Vitros ALT DT Slides) to show "substantial equivalence."
Here's the information extracted and organized based on your request, focusing on the comparative performance data provided:
1. Table of Acceptance Criteria (Comparative Performance) and Reported Device Performance
As this is a 510(k) submission showing substantial equivalence, there are no explicitly stated "acceptance criteria" for a new device's clinical performance. Instead, the performance of the CARESIDE ALT is compared to the predicate device and the new device's performance is presented. The implicit "acceptance criterion" is that the CARESIDE ALT performs "as well as or better than" the predicate device.
| Performance Characteristic | CARESIDE® ALT Reported Performance | Predicate Device (Vitros ALT DT Slides) Reported Performance | Implied "Acceptance" (Substantial Equivalence) |
|---|---|---|---|
| Detection Limit | 15 U/L | 3 U/L | Note: Predicate is lower. This may be acceptable if clinical utility is not impacted at relevant physiological ranges. |
| Reportable Range | 15 - 1000 U/L | 3 - 950 U/L | Note: CARESIDE ALT has a higher upper limit, which may be considered favorable. |
| Accuracy (Mean Recovery) | 106% | Not available | CARESIDE ALT reports a specific value. |
| Precision (Total CV) | 4.5% at 22 U/L | 9.5% at 40 U/L | CARESIDE ALT demonstrates better precision (lower CV) at a lower ALT concentration. |
| Method Comparison (Correlation to BM/Hitachi 902) | CARESIDE® = 0.98 (BM/Hitachi 902) + 4.75 U/L, r = 1.00 | Not available | CARESIDE ALT shows excellent correlation with an established method. |
| Linearity | Slope and correlation coefficient within acceptable limits | Not available | CARESIDE ALT demonstrates linearity. |
| Interference | No significant interference observed at tested concentrations of: | High gamma globulin | CARESIDE ALT shows no significant interference for common interferents tested, and overcomes a known interference of the predicate device (high gamma globulin). |
| - Ascorbic Acid, 10 mg/dL | |||
| - Bilirubin, 20 mg/dL | |||
| - Triglycerides 3000 mg/dL | |||
| - Gamma globulin 4200 mg/dL |
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" (i.e., the number of patient samples or specimens used for the accuracy, precision, linearity, method comparison, and interference studies). It also does not specify the country of origin of the data or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (experts, qualifications, etc.) is typically associated with studies involving human interpretation (e.g., image analysis, diagnoses). The CARESIDE ALT is an in vitro diagnostic device for quantitative chemical measurement. Its "ground truth" would be established by reference methods or laboratory-grade analyzers. Therefore, this information is not applicable and not provided in the document.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are relevant to studies where human readers interpret and classify data, and discrepancies need resolution. This is not applicable to a quantitative in vitro diagnostic device where measurements are compared to reference methods or statistical thresholds for performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improve with AI vs. Without AI Assistance
This section is not applicable. The CARESIDE ALT is an in vitro diagnostic device for measuring a chemical analyte, not an AI-powered diagnostic system requiring human interpretation or assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The performance data presented (accuracy, precision, method comparison, linearity, interference) describes the standalone performance of the CARESIDE ALT device, as it is an automated quantitative measurement system that does not involve human interpretation for its primary function.
7. The Type of Ground Truth Used
The "ground truth" for the performance characteristics appears to be established using:
- Reference Method Comparisons: For accuracy and method comparison, the CARESIDE ALT measurements were compared against results from other established analytical methods, such as the "BM/Hitachi 902" analyzer and a "NADH/NAD coupled reduction of pyruvate by lactate dehydrogenase" reference method. The predicate device also refers to the "IFCC, 1978" method.
- Known Concentrations/Spiked Samples: For linearity, "linearity by mixing" was employed, suggesting known concentrations were used. Interference studies involved adding known concentrations of potential interfering substances.
- Statistical Analysis: Precision is determined through statistical analysis of replicate measurements.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning or AI. This device is a chemical assay, and its development would typically involve optimization and validation runs rather than a distinct "training set" in the computational sense. The document focuses on demonstrating the final product's performance.
9. How the Ground Truth for the Training Set Was Established
As no "training set" in the AI/ML sense is mentioned, this question is not applicable to the information provided. The development of a chemical assay involves extensive R&D, optimization using laboratory standards, and clinical validation using patient samples, but these are not typically categorized as "training sets" with associated "ground truth establishment" in the way an AI algorithm would be described.
§ 862.1030 Alanine amino transferase (ALT/SGPT) test system.
(a)
Identification. An alanine amino transferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.