Anesthesiology
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- MiscellaneousMiscellaneous
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Clinical Toxicology Test SystemsCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart E—Immunology Laboratory Equipment and ReagentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
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Micro Total Analysis Instrument System
- Page Type
- Product Code
- Definition
- A micro total analysis instrument system is a clinical multiplex instrument intended to measure and sort signals generated by fluorescently-labeled immune complexes from a clinical sample on a microcapillary chip. Signals may be quantified using laser-induced-fluorescence detection using filters on a photodiode or other detector. It may integrate microfluidic chips with discrete zones for clinical sample and assay reagents; capillary electrophoresis; reagent handling system; dedicated instrument control; data acquisition software; raw data storage mechanisms; and other essential hardware components and signal reader unit. It is used with specific assays to comprise an assay test system.
- Physical State
- Should not include microarray systems or standard immunoelectrophoresis systems.
- Technical Method
- A micro total analysis instrument system is an automated instrument for clinical multiplex test systems which uses electrokinetic mixing and isotachophoresis on a microfluidic chip to create immune complexes between target analyte(s) from a clinical specimen and fluorescently labeled antibodies. The complexes are detected and quantified using laser-induced-fluorescence detection after capillary gel electrophoresis. The chips contain discrete zones for loading and mixing the sample and assay reagents and for electrophoretic separation. It includes an automated chip loading and transport mechanism, reagent handling (fluidic) system, electrophoresis power supply, control and monitoring systems.
- Target Area
- N/A
- Regulation Medical Specialty
- Chemistry
- Review Panel
- Immunology
- Submission Type
- 510(K) Exempt
- Device Classification
- Class 2
- Regulation Number
- 862.2570
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 862.2570 Instrumentation for clinical multiplex test systems
§ 862.2570 Instrumentation for clinical multiplex test systems.
(a) Identification. Instrumentation for clinical multiplex test systems is a device intended to measure and sort multiple signals generated by an assay from a clinical sample. This instrumentation is used with a specific assay to measure multiple similar analytes that establish a single indicator to aid in diagnosis. Such instrumentation may be compatible with more than one specific assay. The device includes a signal reader unit, and may also integrate reagent handling, hybridization, washing, dedicated instrument control, and other hardware components, as well as raw data storage mechanisms, data acquisition software, and software to process detected signals.
(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems.” See § 862.1(d) for the availability of this guidance document.
[70 FR 11868, Mar. 10, 2005, as amended at 84 FR 71797, Dec. 30, 2019]