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The CARESIDE Triglyceride cartridge is intended for in vitro diagnostic use in conjunction with the CARESIDE Analyzer to quantitatively measure the concentration of triglycerides in anti-coagulated whole blood, plasma or serum. This product is indicated for use in the diagnosis and treatment of patients with primary or secondary hyperlipidemias. Hyperlipidemias may result from liver obstruction, diseases involving lipid metabolism, or various endocrine disorders. Triglyceride results are used together by the CARESIDE Analyzer with total cholesterol and HDL-cholesterol results to calculate LDL-cholesterol levels.

CARESIDE Trighceride cartridges are used with the CARESIDE Analyzer to measure triglyceride concentration in anti-coagulated whole blood, plasma or serum specimens. The CARESIDE Triglyceride cartridge, a single use disposable in vitro diagnostic test cartridge, aids in specimen separation and delivers a measured volume of plasma or serum to a dry film to initiate the measurement of triglyceride concentration. The patented film cartridge contains all reagents necessary to measure triglyceride concentration. Each CARESIDE Triglyceride cartridge consists of a triglyceride-specific multi-layer reagent film mounted in a plastic base with a hinged lid. The user introduces the anticoagulated whole blood, serum, or plasma 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 deposition well into the cartridge channels and chambers. As the cartridge continues to spin, the blood cells are separated from the plasma/serum and the cells accumulate in the separation well. Approximately 8.5 microliters of plasma (or serum, as applicable) remain in the metering passage. Any excess sample flows into an overflow well. The plasma (or serum, as applicable) is automatically dispensed onto the multi-layer The triglyceride-containing specimen is distributed uniformly by the reagent film. spreading layer. The sample then passes through a reflection layer and into the reaction layer. Finally, the reaction mixture is pulled through the reaction layer by a suction layer where the NTB chromogen is converted into a purple formazan dye. As the cartridge spins, a photodiode measures film reflectance of light emitted from a wavelength-specific light emitting diode (LED) at a lixed time. The instrument uses the reflectance measurements and the lot-specific standard curve to calculate triglyceride concentration.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

CARESIDE Triglyceride Premarket Notification (K020488)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by comparing the CARESIDE Triglyceride device's performance characteristics against its predicate device (Vitros TRIG DT Slides) and general analytical standards. The document doesn't explicitly state "acceptance criteria" as a separate section, but rather presents performance characteristics of both devices side-by-side. The key areas of comparison are:

Study Proving Device Meets Acceptance Criteria:

The document describes a comparative performance characteristics study, though the details are somewhat summarized rather than a full protocol.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not explicitly stated for each characteristic. For "Precision," a single sample concentration (146 mg/dL) is mentioned as tested. For "Method Comparison," the slope and intercept are provided, indicating a regression analysis was performed on a set of samples, but the number of samples is not stated. Similarly, for "Interference" and "Specimen Types & Anticoagulants," various conditions were tested, but specific sample numbers (n) are not given.
• Data Provenance: Not explicitly stated. Given that it's a premarket notification for a US market, it's highly likely the data was generated in a lab environment (prospective testing) but the country of origin of the samples themselves is not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not Applicable. This is an in vitro diagnostic device for measuring a biochemical analyte (triglycerides). The "ground truth" for the test set would be established by a well-characterized reference measurement method (e.g., an assay on a high-precision clinical chemistry analyzer like the BM/Hitachi 902, or a gas chromatography-mass spectrometry method if available at the time for direct comparison). It does not involve human expert interpretation of images or clinical cases.

4. Adjudication Method for the Test Set:

• Not Applicable. As this is a quantitative chemical assay, there is no human adjudication process involved in establishing the "ground truth" or comparing results. The comparisons are statistical and analytical.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. An MRMC study is relevant for diagnostic imaging or interpretation tasks where human readers make subjective assessments (e.g., radiologists reading scans). This device is an automated in vitro diagnostic assay, so MRMC studies are not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

• Yes. The entire performance characteristic section (Section IV.C. "Comparative Performance Characteristics") is effectively a standalone performance evaluation of the CARESIDE Triglyceride system (cartridge + Analyzer). The device is designed to be an automated measurement device, and the reported accuracy, precision, linearity, and method comparison data reflect its standalone performance. The document highlights features like "accurate pipetting not required" and "reagent pre-warming not required," which further emphasize its automated, standalone nature.

7. The Type of Ground Truth Used:

• For Method Comparison, the ground truth was established by another well-accepted clinical chemistry analyzer, specifically the "BM/Hitachi 902." The comparison yielded the equation: CARESIDE = 0.98 (BM/Hitachi 902) + 2.92 mg/dL. This indicates the BM/Hitachi 902 served as the reference or comparative "ground truth" for evaluating the CARESIDE device's quantitative accuracy.
• For Accuracy (Recovery), the ground truth would be the known concentration of triglycerides in spiked samples or certified reference materials, where the device's measured value is compared to the expected true value.
• For Precision, the ground truth is the statistical property of repeatability and reproducibility, typically assessed by running samples multiple times to determine the variability (CV%).
• For Linearity, the ground truth is derived from preparing samples with known serially diluted or mixed concentrations and ensuring the device's readings are proportional to these known values.

8. The Sample Size for the Training Set:

• Not applicable / Not explicitly stated for this type of device. Clinical chemistry devices like this typically undergo extensive analytical validation (accuracy, precision, linearity, interference) using characterized samples. While there's an internal "lot-specific standard curve" mentioned for calibration, this isn't a "training set" in the machine learning sense. The device's underlying chemistry and optical detection principles are well-established. The development process would involve optimizing reagents and calibration, but the specific term "training set" with a defined sample size as used in AI/ML is not relevant here.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable for a "training set" in the AI/ML sense. For the calibration curves that the instrument uses, "ground truth" is established through carefully characterized calibrator materials with known triglyceride concentrations, measured by highly accurate reference methods. The device then generates a standard curve based on these calibrators to convert raw reflectance data into triglyceride concentrations.

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