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For in vitro diagnostic use with the CARESIDE Analyzer™ to measure CK-MB from whole blood, serum or plasma specimens to aid in the diagnosis and treatment of patients with myopathic disorders including myocardial infarction, myocarditis, Duchenne's muscular dystrophy, polymyosititis, and rhabdomyolysis.

CARESIDE™ CKMB cartridges are used with the CARESIDE, Inc. CARESIDE Analyzer™ to measure CK-MB activity in whole blood, serum or plasma specimens. The CARESIDE™ CKMB 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 CK-MB activity. The film cartridge (patent pending) contains all reagents necessary to measure CK-MB activity.

Each CARESIDE™ CKMB cartridge consists of a CK-MB-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 uL of sample remains in the metering passage. Any excess sample flows into an overflow well.

The sample is automatically dispensed onto the multi-laver reagent film. The spreading layer distributes the specimen uniformly. In this layer CK-M activity is inhibited by the anti-CK-M subunit antibody contained in the layer. The CK-B subunit is not inhibited by the antibody but rather is activated by N-acetylcysteine. The CK-B activity is stoichometrically related to the CK-MB activty. The CK-B catalyzes the reaction of creatine phosphate with ADP, producing creatine and ATP. ATP reacts with endogenous glucose in a hexokinase-catalyzed reaction to produce glucose-6-phosphate and ADP. G-6-P is then oxidized by glucose-6-phosphate dehydrogenase producing nicotinamide adenine dinucleotide (NADH). NADH reduces nitrotetrazolium blue in a diaphorase catalyzed reaction, producing a diformazan dye. The rate of change of the color intensity of the resulting reddish dye, as measured by the amount of reflected light at 570 nanometers, directly relates to the specimen CK-MB activity.

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 CK-MB activity.

Here's a summary of the acceptance criteria and study information for the CARESIDE™ CKMB device, based on the provided text:

Acceptance Criteria and Device Performance

Study Information

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

   • Test Set Sample Size: Not explicitly stated in the provided text. The "Method comparison" section mentions "CARESIDE™ = 1.00 (Paragon) - 8.9 U/L, r = 0.98," which implies a comparison study was performed, but the number of samples used for this correlation is not provided.
   • Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts: Not applicable. This device is an in vitro diagnostic (IVD) for quantitative measurement of a biomarker, not an interpretative AI device requiring expert adjudication of images or signals. The "ground truth" for its performance is typically established by comparison to reference methods or validated laboratory measurements.

3. Adjudication Method for the Test Set: Not applicable for this type of IVD device.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done: No, this is not an MRMC study. MRMC studies are typically for medical image analysis or diagnostic interpretation by human readers, often comparing performance with and without AI assistance. This device is a quantitative diagnostic test.

5. If a Standalone Performance Study Was Done: Yes, a standalone performance study was conducted. The "Comparative Performance Characteristics" section directly reports the CARESIDE™ CKMB's performance metrics (detection limit, reportable range, accuracy, precision, linearity, interference) independently, and then compares them against the predicate device where possible. The method comparison with "Paragon" also represents a standalone assessment against an established method.

6. The Type of Ground Truth Used:

   • For Method Comparison: The device's results were compared against an unstated "Paragon" method (likely an established laboratory reference method).
   • For Reference Method: The text states the reference method for % CKMB was "Electrophoresis for % CKMB in combination with kinetic spectrophotometric determination of total CK." This is what would be considered the "ground truth" or gold standard for validating the CK-MB measurements.

7. The Sample Size for the Training Set: Not applicable. This device is an in vitro diagnostic assay, not an AI/ML model that requires a "training set" in the conventional sense. Its "training" is inherent in its chemical design and calibration process.

8. How the Ground Truth for the Training Set Was Established: Not applicable. As an IVD assay, its accuracy relies on the validated chemical reactions and calibration materials rather than a "training set" with established ground truth labels. Calibration information is "bar-coded on each cartridge" and can change with each lot, indicating internal validation processes.

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