HEMOSIL LIQUID ANTITHROMBIN

K062431 · Instrumentation Laboratory CO · JBQ · Sep 1, 2006 · Hematology

Device Facts

• Record ID: K062431
• Device Name: HEMOSIL LIQUID ANTITHROMBIN
• Applicant: Instrumentation Laboratory CO
• Product Code: JBQ · Hematology
• Decision Date: Sep 1, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7060
• Device Class: Class 2

Indications for Use

HemosIL Liquid Antithrombin is an automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma as an aid in the diagnosis of hereditary and acquired Antithrombin deficiency and to monitor Antithrombin substitution therapy. This in vitro diagnostic test is based on a synthetic chromogenic substrate and on Factor Xa inactivation. As a consequence, it is specific and not influenced by Heparin Cofactor II. Antithrombin levels in patient plasma are measured automatically on IL Coagulation Systems.

Device Story

HemosIL Liquid Antithrombin is an automated in vitro diagnostic assay for human citrated plasma. It utilizes a synthetic chromogenic substrate and Factor Xa inactivation to measure Antithrombin levels, ensuring specificity by avoiding interference from Heparin Cofactor II. The assay is performed automatically on IL Coagulation Systems in a clinical laboratory setting. Results are used by clinicians to diagnose Antithrombin deficiency and monitor substitution therapy. The device provides quantitative data to support clinical decision-making regarding patient coagulation status.

Clinical Evidence

No clinical data; bench testing only. The submission relies on literature-based reference ranges (Kottke-Marchant K, Duncan A. Arch Pathol Lab Med. 2002) to update the product labeling.

Technological Characteristics

In vitro diagnostic liquid assay for antithrombin. Modification is informational (labeling update) rather than physical or chemical. No changes to sensing principle or materials.

Indications for Use

Indicated for quantitative determination of Antithrombin in human citrated plasma to aid in diagnosis of hereditary and acquired Antithrombin deficiency and to monitor Antithrombin substitution therapy.

Regulatory Classification

Identification

An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
ODE Review Memorandum

To: THE FILE
RE: DOCUMENT NUMBER K062431

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 "Expected Value" section of the HemosIL Liquid Antithrombin assay package insert reference for normal range.

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 normal range value which is modified to reference a range from published literature, reinforcing the need for each laboratory to establish its own normal range due to the variables which may affect 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: 3/27/98