(62 days)
It is intended to be used for automating sample preparation or assay methods and is capable of aspirating, dispensing or diluting fluids to any position on the instruments work area.
The MSP 9500 Mini Sample Processor is a microprocessor controlled pipetting and diluting system. It is designed to be used for automating sample preparation or assay methods. It is capable of aspirating, dispensing or diluting to any position on the instrument work area. An XYZ robotic positioner moves the pipetting and dispensing tip to the desired XY position then lowers it in the Z direction into the sample. A fluid pump is then used to either aspirate or dispense the desired quantity of sample or reagent. The unit is modular, allowing customization for specific applications. It consists of an enclosure, one or two XYZ robotic modules, power supply, central controller unit, connector for interfacing with an external computer, one or more fluid pumps and may be configured with a variety of optional pumps. valves and accessories. Modular racks will accommodate many types of commonly used tubes and microwell plates. It may be private labeled to meet individual needs.
The provided text describes the performance data for the CAVRO SCIENTIFIC INSTRUMENTS INC. MSP 9500 Mini Sample Processor. Below is a breakdown of the requested information based on the document.
1. Table of Acceptance Criteria and Reported Device Performance
Mechanical Positioning
| Characteristic | Specification | Test Results |
|---|---|---|
| X-AXIS TRAVEL RANGE, 1 ARM (MIN.) | 643 mm (25.31 in) | 650 mm (25.6 in) |
| ACCURACY | ± 0.20 mm (0.008 in) | ± 0.18 mm (0.007 in) |
| REPRODUCIBILITY | ± 0.10 mm (0.004 in) | ± 0.05 mm (0.002 in) |
| X-AXIS TRAVEL RANGE, 2 ARM (MIN.) | 563 mm (22.17 in) | 574 mm (22.60 in) |
| ACCURACY | ± 0.20 mm (0.008 in) | ± 0.18 mm (0.007 in) |
| REPRODUCIBILITY | ± 0.10 mm (0.004 in) | ± 0.05 mm (0.002 in) |
| Y-AXIS TRAVEL RANGE (MINIMUM) | 300 mm (11.81 in) | 303 mm (11.9 in) |
| ACCURACY | ± 0.20 mm (0.008 in) | ± 0.10 mm (0.004 in) |
| REPRODUCIBILITY | ± 0.10 mm (0.004 in) | ± 0.07 mm (0.003 in) |
| Z-AXIS TRAVEL RANGE (MINIMUM) | 165 mm (6.50 in) | 167 mm (6.6 in) |
| ACCURACY | ± 0.40 mm (0.016 in) | ± 0.11 mm (0.004 in) |
| REPRODUCIBILITY | ± 0.10 mm (0.004 in) | ± 0.06 mm (0.002 in) |
Liquid Handling (Standard Unit, Using Model XL3000 Pump)
Within Run Inaccuracy and Imprecision
| Dispense Volume | Inaccuracy Specification | Inaccuracy Test Results | Imprecision (CV) Specification | Imprecision (CV) Test Results |
|---|---|---|---|---|
| 250 uL Syringe | ||||
| 250 uL Dispense |
§ 862.2750 Pipetting and diluting system for clinical use.
(a)
Identification. A pipetting and diluting system for clinical use is a device intended to provide an accurately measured volume of liquid at a specified temperature for use in certain test procedures. This generic type of device system includes serial, manual, automated, and semi-automated dilutors, pipettors, dispensers, and pipetting stations.(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.