STA COMPACT MAX

K130090 · Diagnostica Stago, Incorporated · JPA · Feb 12, 2013 · Hematology

Device Facts

• Record ID: K130090
• Device Name: STA COMPACT MAX
• Applicant: Diagnostica Stago, Incorporated
• Product Code: JPA · Hematology
• Decision Date: Feb 12, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Indications for Use

The STA Compact is a fully automated, random access, coagulation analyzer intended for in vitro diagnostic use in clinical laboratories to perform coagulation and fibrinolysis assays on human citrated plasma.

Device Story

STA Compact; fully automated, random access, coagulation analyzer. Input: human citrated plasma samples. Operation: performs coagulation and fibrinolysis assays. Modification: migration to Windows OS; new peripherals (USB, CD/DVD); updated graphical user interface (GUI) for improved usability; external design changes (color/shape). Use: clinical laboratory setting; operated by trained laboratory personnel. Output: assay results for hemostasis disorder diagnosis/monitoring. Benefit: increased operational reliability; improved user interface; obsolescence management.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, verification, and validation studies confirming that the modified device performs identically to the predicate.

Technological Characteristics

Fully automatic clinical analyzer. Detection: chronometric (mechanical oscillation of metal ball via inductive sensors) and photometric (light absorbance at 405μm, 540μm). Connectivity: USB, RJ45, parallel port. Peripherals: CD/DVD, touch screen. Integrated PC. Firmware versions (MSTB, GSTB, ISTB, CSTB, MPP) are identical to the predicate. Electrical safety: UL Listed.

Indications for Use

Indicated for use in hospital or healthcare laboratories to perform in vitro diagnostic tests on human plasma to aid in the diagnosis of coagulation abnormalities or monitoring of anticoagulant therapy in patients.

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.

Predicate Devices

• STA Compact® (K093167)

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 K130090

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. Diagnostica Stago STA Compact ®, k093167 previously cleared device.
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 modifications which include: (1) the on-board computer to allow the use of Windows operating system and new peripherals (USB, CD/DVD), (2) the migration of the application software with a new graphical user interface to improve the ease of use, to include operator/user enhancements and to manage obsolescence, and (3) the modifications in the external design (color and shape), are only for a marketing purpose.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and assay methods. The difference is in minor hardware, software, and physical characteristics to increase the reliability of operation, software to provide operator/user enhancements and external design for marking exhibition.

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. (Attachment 12)
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. (Attachment 19)
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, (Attachment 11) 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. (Attachment 11)

6. A Truthful and Accurate Statement, a 510(k) Summary and the Indications for Use Enclosure. (Page 4, Attachments 1 and 10 respectively)

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.