STA LIATEST FREE PS

K092170 · Diagnostica Stago, Inc. · GGP · Dec 22, 2009 · Hematology

Device Facts

• Record ID: K092170
• Device Name: STA LIATEST FREE PS
• Applicant: Diagnostica Stago, Inc.
• Product Code: GGP · Hematology
• Decision Date: Dec 22, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7290
• Device Class: Class 2

Indications for Use

The STA® - Liatest® Free PS kits are intended for use with analyzers of the STA® line suitable with these reagents for the antigenic assay of free Protein S in plasma by the immuno-turbidimetric method.

Device Story

STA® - Liatest® Free PS; immunoturbidimetric assay; measures free Protein S antigen in human citrated plasma; used on STA® analyzers; modification involves transition from pre-calibration to external calibration plasmas; clinical laboratory setting; operated by laboratory technicians; output used by clinicians to assess Protein S levels; aids in coagulation disorder evaluation.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological and performance comparisons to the predicate device.

Technological Characteristics

Latex microparticles coated with two mouse monoclonal anti-human free protein S antibodies; stabilized with bovine albumin; HEPES buffer; immuno-turbidimetric assay principle; requires external calibrator plasmas; compatible with STA line analyzers.

Indications for Use

Indicated for the antigenic assay of free Protein S in citrated human plasma using STA line analyzers for patients requiring assessment of Protein S levels.

Predicate Devices

• STA® Liatest® Free Protein S (K010963)

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 K092170

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. STA® - Liatest® Free PS, K010963 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 the addition of external calibration plasmas.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and stability. The difference is in the use of external calibrators instead of pre-calibration for the assay.
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 4B)
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 (Pages 12-16)
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 (Attachment 4A)
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 4A)

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.