SENTINEL CHOLINESTERASE LIQUID

K051444 · Sentinel Ch. Srl · DIH · Jun 20, 2005 · Clinical Toxicology

Device Facts

• Record ID: K051444
• Device Name: SENTINEL CHOLINESTERASE LIQUID
• Applicant: Sentinel Ch. Srl
• Product Code: DIH · Clinical Toxicology
• Decision Date: Jun 20, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3240
• Device Class: Class 1

Intended Use

The Sentinel Cholinesterase Liquid assay is used to measure cholinesterase in human specimens. There are two principal type of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is note present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition and disorders. For In Vitro diagnostics use only. CFR 862.3240

Device Story

Sentinel Cholinesterase Liquid; in vitro diagnostic reagent for quantitative determination of cholinesterase activity in human serum or plasma. Modification enables use on Abbott AEROSET and ARCHITECT c8000 analyzers. Device operates via automated clinical chemistry analysis; provides quantitative results to clinicians for assessment of cholinesterase levels. Used in clinical laboratory settings by trained laboratory personnel. Output assists in diagnosis and monitoring of cholinesterase-related conditions.

Clinical Evidence

Bench testing only. Validation protocols addressed hazards identified in risk analysis (FMEA). Results demonstrated that predetermined acceptance criteria were met for the modified device performance on Abbott AEROSET and ARCHITECT c8000 analyzers.

Technological Characteristics

In vitro diagnostic reagent; liquid formulation. Quantitative enzymatic assay. Designed for use on automated clinical chemistry analyzers (Abbott AEROSET and ARCHITECT c8000).

Indications for Use

Indicated for quantitative determination of cholinesterase in human serum and plasma for the diagnosis and treatment of cholinesterase inhibition and disorders.

Regulatory Classification

Identification

A cholinesterase test system is a device intended to measure cholinesterase (an enzyme that catalyzes the hydrolysis of acetylcholine to choline) in human specimens. There are two principal types of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes (red blood cells) but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is not present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).

Predicate Devices

• Sentinel Cholinesterase Liquid Model Number 17.019A and 17.606 assay on Hitachi 717 (K981800)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K051444

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Reserved Class I device. The following items are present and acceptable (delete/add items as necessary) for the SENTINEL CHOLINESTERASE LIQUID:

1. The name and 510(k) number of SENTINEL CH. SRL's previously cleared device, SENTINEL CHOLINESTERASE LIQUID, cleared under KK981800. (For a preamendments device, a statement to this effect has been provided.)

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials.

3. A description of the device MODIFICATION (S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for use on Abbott's AEROSET and ARCHITECT c8000 Analyzers.

Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics.

4. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied

c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and

ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

Comments – Validation Protocols were adequate to address the identified causes of hazards identified in the Risk analysis (FMEA)

revised:3/27/98