(174 days)
The Thermo Scientific Indiko Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used.
The Indiko Glucose (HK) test system, is intended for in vitro diagnostic use in the quantitative determination of the glucose concentration in human plasma on the Indiko analyzer.
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
The Indiko is automated random access discrete photometric analyzer, capable of performing up to 30 photometric tests.
The sample disk has an integrated barcode reader which allows cup/tube recognition. The barcode reader can read the following codes: code 128, USS Codabar, interleaved 2 of 5 and code 39 with check digit.
Reaction cells are discrete disposable (single use) multicell cuvettes with 10 reaction measurement cells in a row. On-board capacity of 36 multicell cuvettes (equal to 360 reaction cells), with continuous loading capability, typically 2 hours walk-away time. The quality of the reaction cells is checked at the start of the routine work automatically. The measurements are performed at 37℃.
The analyzer incorporates robotics, computer, and communication technology to render simple and reliable long-term operation. The operating system works with Windows® 7. The user interface software is graphical. The data input can be done online or by touch screen or mouse or keyboard.
Reagents are liquid, the reagent bottles are placed on the reagent/sample disk, which holds maximum 30 positions, the reagent/sample disk is cooled 10℃ below ambient temperature.
Here's a breakdown of the acceptance criteria and study details for the Indiko Glucose (HK) system, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance | Performance Accepted |
|---|---|---|---|
| Method Comparison | y = ax + b, where a = 1.00 ± 0.03, b = 0.00 ± 3.6 mg/dl, r ≥ 0.97, max bias at 90 mg/dl 5% | y = 1.01x + 0.7, r = 1, Range: 6 - 700 mg/dl | Yes |
| Precision (Within run) | Low: CV ≤ 2.0 % | ||
| Middle: CV ≤ 2.0 % | |||
| High: CV ≤ 1.8 % | Low: CV 0.7 % | ||
| Middle: CV 0.6 % | |||
| High: CV 0.8 % | Yes | ||
| Precision (Between run) | Not specified | Low: CV 0.8 % | |
| Middle: CV 1.2 % | |||
| High: CV 0.6 % | Yes | ||
| Precision (Total) | Low: CV ≤ 3.5 % | ||
| Middle: CV ≤ 3.5 % | |||
| High: CV ≤ 3.0 % | Low: CV 1.6 % | ||
| Middle: CV 1.5 % | |||
| High: CV 1.5 % | Yes | ||
| Linearity/Measuring Range | Measuring range: 5 - 720 mg/dl | ||
| Maximum bias from the estimated straight line ± 2.7 mg/dl or ± 5 %. | Measuring range: 5 - 720 mg/dl | Yes | |
| Limit of Blank (LoB) | LoB: |
§ 862.2160 Discrete photometric chemistry analyzer for clinical use.
(a)
Identification. A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.(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.