HEMOSIL PROS

K053499 · Instrumentation Laboratory CO · GGP · Jan 13, 2006 · Hematology

Device Facts

• Record ID: K053499
• Device Name: HEMOSIL PROS
• Applicant: Instrumentation Laboratory CO
• Product Code: GGP · Hematology
• Decision Date: Jan 13, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7290
• Device Class: Class 2

Indications for Use

HemosIL ProS is a functional assay for the quantitative determination of free Protein S in human citrated plasma on IL coagulation systems as an aid in the diagnosis of hereditary and acquired Protein S deficiency. This in vitro diagnostic test determines the functional activity of free Protein S by measuring the degree of prolongation of a prothrombin time in the presence of the tissue factor, phospholipids, calcium ions and activated Protein C. The Protein S activity is proportional to the prolongation of the clotting time of a Protein S deficient plasma to which the diluted sample was added.

Device Story

Modification to HemosIL ProS reagent for use on ACL Future and ACL Advance systems; modification involves updated labeled reconstituted and on-board stability claims; on-board stability claim set to 1 hour; reconstituted 2-8°C stability claim set to 12 hours; fundamental scientific technology remains unchanged; device used in clinical laboratory settings for coagulation testing.

Clinical Evidence

Bench testing only; verification and validation activities performed to support updated stability claims; risk analysis conducted to assess impact of modification.

Technological Characteristics

In vitro diagnostic reagent (HemosIL ProS); stability-modified; intended for use on ACL Future and ACL Advance coagulation analyzers.

Indications for Use

Indicated for the quantitative determination of free Protein S in human citrated plasma to aid in the diagnosis of hereditary and acquired Protein S deficiency.

Predicate Devices

• HemosIL ProS (K011424)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
ODE Review Memorandum

To: THE FILE
RE: DOCUMENT NUMBER K053499

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.
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.

The modification is to the labeled reconstituted and on-board stability claims on the ACL Future and ACL Advance for the HemosIL ProS reagent.

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 stability claim; on-board claim is 1 hour and the reconstituted 2-8° C claim is 12 hours.
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 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
(Reviewer's Signature)
(Date)

Revised: 3/27/98