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510(k) Data Aggregation
(69 days)
HICHEM DIAGNOSTICS
HiChem Calcium Reagent is intended for the quantitative determination of total calcium in serum, plasma and urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
The HiChem Calcium Reagent determines calcium by its reaction with arsenazo III to form a blue complex. The resulting increase in absorbance at 650 nm is proportional to the calcium concentration in the sample. The HiChern Calcium Reagent is an adaptation of the arsenazo III calcium method, first reported by Michaylova and Illikova and is intended to be used either as a manual procedure or on clinical analyzers which can automate the required manipulations.
Here's a breakdown of the acceptance criteria and study information for the HiChem Calcium Reagent, based on the provided text:
Acceptance Criteria and Device Performance
The provided text describes two main scenarios for the HiChem Calcium Reagent: the manual procedure and its use on the Beckman® SYNCHRON CX® Systems (secondary reagent application). The acceptance criteria are largely implied by the reported performance, as the study aims to demonstrate substantial equivalence to an existing predicate device.
Table of Acceptance Criteria and Reported Device Performance
| Performance Measure | Acceptance Criteria (Implied) | HiChem Calcium Reagent (Manual Procedure) Reported Performance | HiChem Calcium Reagent (SYNCHRON CX® Systems) Reported Performance |
|---|---|---|---|
| Linearity | Demonstrate linearity over a specific range. | Linear between 0.1 to 16 mg/dL. Regression: (HiChem) = -0.1 + 0.980 x (Standard Conc.), r² = 1.000, sy.x = 0.14 mg/dL. | Linear from at least 2.0 mg/dL to 15.0 mg/dL. Regression: (HiChem) = 0.0 + 0.967 x (Standard Conc.), r² = 1.000, sy.x = 0.08 mg/dL. |
| Precision | Meet specified SD for various control levels. | Serum Control 1 (6.69 mg/dL): within-run SD 0.21 mg/dL, total SD 0.24 mg/dL | |
| Serum Control 2 (12.68 mg/dL): within-run SD 0.29 mg/dL, total SD 0.30 mg/dL | |||
| Urine Pool 1 (2.41 mg/dL): within-run SD 0.11 mg/dL, total SD 0.11 mg/dL | |||
| Urine Pool 2 (11.10 mg/dL): within-run SD 0.13 mg/dL, total SD 0.16 mg/dL | Serum Control 1 (6.89 mg/dL): within-run SD 0.056 mg/dL, total SD 0.064 mg/dL | ||
| Serum Control 2 (10.03 mg/dL): within-run SD 0.085 mg/dL, total SD 0.089 mg/dL | |||
| Serum Control 3 (13.21 mg/dL): within-run SD 0.088 mg/dL, total SD 0.090 mg/dL | |||
| Urine Pool 1 (3.24 mg/dL): within-run SD 0.048 mg/dL, total SD 0.059 mg/dL | |||
| Urine Pool 2 (11.64 mg/dL): within-run SD 0.075 mg/dL, total SD 0.095 mg/dL | |||
| Method Comparison (Serum/Plasma) | Substantial equivalence to Beckman® SYNCHRON® Calcium Reagent. | n=92. Regression: (HiChem) = -0.3 + 1.020 × (BMD® Results), r² = 0.887, s(y.x) = 0.21 mg/dL. | n=153. Regression: (HiChem) = -0.3 + 1.005 x (Beckman® Results), r² = 0.924, s(y.x) = 0.20 mg/dL. |
| Method Comparison (Urine) | Substantial equivalence to Beckman® SYNCHRON® Calcium Reagent. | Regression: (HiChem) = 0.2 + 1.022 × (BMD® Results), r² = 0.998, s(y.x) = 0.15 mg/dL. | Regression: (HiChem) = 0.1 + 1.031 x (Beckman® Results), r² = 0.996, s(y.x) = 0.16 mg/dL. |
| Chemical Additives (Interference) | Biases less than a specified threshold (e.g., |
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(27 days)
HICHEM DIAGNOSTICS
HiChem ALP/AMP Reagent (product no. 70001) is intended for the quantitative determination of alkaline phosphatase in serum and plasma. The principal diagnostic indications of elevated serum alkaline phosphatase are diseases of the liver, bone, parathyroid and intestine.
The HiChem ALP/AMP Reagent determines alkaline phosphatase by enzymatic hydrolysis of p-nitrophenylphosphate to p-nitrophenoxide at alkaline pH. The HiChem ALP/AMP Reagent is intended to be used either as a manual procedure or on clinical analyzers which can automate the required manipulations. The reagent is supplied as two liquid-stable components which are combined, either before or during use, in the approximate ratio of 1 part ALP/AMP Substrate and 5 parts ALP/AMP Reagent Buffer. The ALP/AMP Substrate can also be used as a start reagent and combined with the Reagent Buffer following sample addition.
Here's a breakdown of the acceptance criteria and study information for the HiChem ALP/AMP Reagent, based on the provided text:
Important Note: The provided document is a 510(k) summary for a diagnostic reagent, not a medical device in the typical sense of AI-powered imaging or diagnostic software. Therefore, many of the requested categories (e.g., number of experts, adjudication methods, MRMC studies, standalone performance for AI, training set details) are not applicable to this type of submission. This document focuses on demonstrating substantial equivalence to existing, legally marketed devices through analytical performance characteristics.
Acceptance Criteria and Reported Device Performance
Device: HiChem ALP/AMP Reagent (product no. 70001)
Intended Use: Quantitative determination of alkaline phosphatase (ALP) in serum and plasma.
| Acceptance Criteria Category | Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|---|
| Manual Procedure | ||
| Linearity (30°C) | Linear to at least 900 U/L | Linear to at least 900 U/L (Recoveries at 30°C) = -1.7 U/L + 1.005 x (Standard Activity), r² = 0.9998, sy.x = 6.5 U/L |
| Linearity (37°C) | Linear to at least 900 U/L | Linear to at least 900 U/L (Recoveries at 37°C) = 2.9 U/L + 0.969 x (Standard Activity), r² = 0.9998, sy.x = 8.0 U/L |
| Precision (37°C) | Replicate assay with acceptable within-run and total SD values (implied by tabulated results) | See table below for detailed precision results at 37°C (n=30 for each control). |
| Comparison to MAS ALP Reagent | Acceptable correlation and agreement (implied by regression statistics) | r² = 0.9986, (HiChem Results) = -0.2 U/L + 1.058 x (MAS Results), sy.x = 5.5 U/L |
| Anticoagulant Interference | Bias |
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