STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER

K082675 · Diagnostica Stago, Inc. · JPA · Oct 10, 2008 · Hematology

Device Facts

• Record ID: K082675
• Device Name: STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER
• Applicant: Diagnostica Stago, Inc.
• Product Code: JPA · Hematology
• Decision Date: Oct 10, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Indications for Use

The STA-R® Evolution (or STA-R®) Automated Multi-Parametric Analyzer is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

Device Story

STA-R® Evolution is a fully automated clinical analyzer for coagulation testing. Instrument accepts human plasma samples and reagents; performs sample handling, reagent delivery, analysis, and result reporting. Utilizes chronometric (clot-based) and photometric assays. Central processing unit manages patient results, quality control, system supervision, and maintenance. Used in clinical laboratory settings by trained personnel. Modification involves upgrading operating system from Windows NT to Windows XP with minor application software enhancements. Output provides coagulation test results to assist clinicians in diagnosing abnormalities or monitoring anticoagulant therapy, facilitating patient management.

Clinical Evidence

No clinical data; bench testing and design control verification/validation activities performed to confirm software modification safety and performance.

Technological Characteristics

Software-based modification to on-board computer operating system and application software. Fundamental scientific technology, mechanical operation, and sample processing logic remain unchanged from predicate device.

Indications for Use

Indicated for use on human plasma samples to aid in the diagnosis of coagulation abnormalities or monitoring of anticoagulant therapy. For prescription use only.

Regulatory Classification

Identification

A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

Special Controls

*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K_082675

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

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (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 (labeling changes are permitted as long as they do not affect the intended use).
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 **software modifications, specifically (1) a change in the device on-board computer operating system software, without any change in the technology or mechanical operation by which samples are processed; (2) a change in the device application software to accommodate the new operating system and provide operator/user enhancements without logic configuration changes.**

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

5. 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 and the Indications for Use Enclosure.

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.