(56 days)
The ISE Reagents are intended for use on the ISE Module of the BMD Hitachi Clinical Chemistry Systems. The ISE High and Low Calibrators are intended to provide calibration points for the Na +, K+, and Cl- Electrodes on the ISE Subsystem. The IN KCI Solutions are intended to provide stable reference potential for the Na +, K+, and Cl- Electrodes. The ISE Diluent dilutes all measured patient samples for the quantitative determination of Na +, K+, and Cl- in Serum, Plasma and Urine by ISE. The ISE Internal Reference Solutions are intended as a means of compensating for calibration drift in the quantitative determination of Na +, K+, and Cl- in Serum, Plasma and Urine samples on the BMD Hitachi Clinical Chemistry Systems.
All product(s) encompassed by this 510(k) submission are Class I (75JJG) and Class II (75JIX) In Vitro Diagnostic Solutions manufactured by ALKO Diagnostic Corporation. The ISE Reagents are intended for use on the ISE Module of the BMD Hitachi Clinical Chemistry Systems. The ISE High and Low Calibrators are intended to provide calibration points for the Na +, K+, and Cl- Electrodes on the ISE Subsystem. The IN KCI Solutions are intended to provide stable reference potential for the Na +, K+, and Cl- Electrodes. The ISE Diluent dilutes all measured patient samples for the quantitative determination of Na +, K+, and Cl- in Serum, Plasma and Urine by ISE. The ISE Internal Reference Solutions are intended as a means of compensating for calibration drift in the quantitative determination of Na +, K+, and Cl- in Serum, Plasma and Urine samples on the BMD Hitachi Clinical Chemistry Systems.
Here's an analysis of the acceptance criteria and study detailed in the provided text:
Device: ALKO Diagnostic Corporation ISE Reagents for BMD Hitachi Clinical Chemistry 700 Series and 911 Systems
Description of Device: ISE Reagents (Diluent, Internal Reference Solution, 1N KCI Solution, Low Standard, High Standard) intended for use on the ISE Module of BMD Hitachi Clinical Chemistry Systems for the quantitative determination of Na+, K+, and Cl- in Serum, Plasma, and Urine. They are designed as direct replacements for Boehringer Mannheim Diagnostic (BMD) products.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the sponsor's claim of "performance equivalence" to the predicate BMD reagents. The study aims to demonstrate that results obtained with ALKO reagents are comparable to those obtained with BMD reagents, and that ALKO reagents exhibit acceptable precision.
Performance Equivalence (Correlation Study):
The acceptance criteria are not explicitly stated as numerical thresholds (e.g., "slope must be between X and Y"). Instead, the document presents linear regression results (Slope, Intercept, R-squared) between ALKO and BMD reagents, implying that a slope close to 1, an intercept close to 0, and a high R-squared value (close to 1) indicate equivalence. For the purpose of this table, we will highlight the reported statistics.
Precision Study:
The acceptance criteria for precision are also not explicitly stated in numerical terms (e.g., "CV% must be
§ 862.1170 Chloride test system.
(a)
Identification. A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.(b)
Classification. Class II.