HEMOSIL LIQUID ANTITHROMBIN XL

K033775 · Instrumentation Laboratory CO · JBQ · Jan 2, 2004 · Hematology

Device Facts

• Record ID: K033775
• Device Name: HEMOSIL LIQUID ANTITHROMBIN XL
• Applicant: Instrumentation Laboratory CO
• Product Code: JBQ · Hematology
• Decision Date: Jan 2, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7060
• Device Class: Class 2

Indications for Use

Hemos L Liquid Antithrombin XL is a modified version of HemosIL Liquid Antithrombin (K994238) with optimized reagent volumes for use on specific IL Coagulation Systems, such as the ACL Futura (K951891) and ACL Advance (K002400). This modification does not alter the fundamental scientific technology of the device or its intended use as 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. For in vitro diagnostic use.

Device Story

HemosIL Liquid Antithrombin XL is an automated chromogenic assay for quantitative Antithrombin determination in human citrated plasma. Used on IL Coagulation Systems (e.g., ACL Futura, ACL Advance) in clinical laboratory settings. Device utilizes optimized reagent volumes to measure Antithrombin levels; results assist clinicians in diagnosing hereditary/acquired Antithrombin deficiency and monitoring substitution therapy. Operates via automated analysis of plasma samples; provides quantitative output for healthcare provider review.

Clinical Evidence

Bench testing only. Precision assessed via within-run and between-run studies using normal and two abnormal control levels (n=60 per level). Within-run %CV ranged from 2.5% to 6.4%; between-run %CV ranged from 3.4% to 7.4%. Method comparison performed against predicate device.

Technological Characteristics

Reagent-based diagnostic device. Modifications focused on reagent stability and volume. Design controls per 21 CFR 820.30 applied.

Indications for Use

Indicated for the quantitative determination of Antithrombin in human citrated plasma to aid in the 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 K033775

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.

This change was for improving vial-to-vial variability and stability and to increase the volumes for kit reagents.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and clinical performance data (accuracy, precision, linearity, minimum detection limit, normal range, and interference).

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