HEMOSIL PROCLOT

K070635 · Instrumentation Laboratory CO · GGP · Mar 29, 2007 · Hematology

Device Facts

• Record ID: K070635
• Device Name: HEMOSIL PROCLOT
• Applicant: Instrumentation Laboratory CO
• Product Code: GGP · Hematology
• Decision Date: Mar 29, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7290
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

HemosIL ProClot is an automated functional clotting Protein C assay for the quantitative determination of Protein C in human citrated plasma on the IL Coagulation Systems.

Device Story

HemosIL ProClot is an automated functional clotting assay for quantitative Protein C determination in human citrated plasma. Used on IL Coagulation Systems in clinical laboratory settings. Principle of operation: prolongation of an APTT assay in the presence of activated Protein C; activated Protein C is generated in plasma samples using Protac, a snake venom activator (Agkistrodom contortrix contortrix). The assay measures the anticoagulant effect of activated Protein C, which is sensitive to Factor V and Factor VIII levels. Results are used by clinicians to assess Protein C deficiency associated with venous thrombosis, pulmonary embolism, hepatic disorders, and disseminated intravascular coagulation.

Clinical Evidence

No clinical data. The submission relies on literature citation (Kottke-Marchant K, Comp P. Arch Pathol Lab med 2002) to support the modification of the Expected Values section in the product labeling.

Technological Characteristics

In vitro diagnostic reagent for Protein C activity measurement. Modification is limited to labeling (Expected Value section). No changes to chemical composition, sensing principle, or physical form factor.

Indications for Use

Indicated for the quantitative determination of Protein C activity in human plasma.

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 K070635

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:

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: Normal range in the Expected Value Section of the HemosIL ProClot (Protein C) product insert.

4. Comparison Information to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics.

The difference: The sponsor replaced their normal range studies with a normal range cited from a published literature, including additional information for neonate/infants. This approach reinforces the need for each laboratory to establish its own Protein C normal range due to many variables which may affect the results.

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.

(Reviewer's Signature)

(Date)

Comments

revised: 8/1/03