HEMOSIL ANTITHROMBIN

K070301 · Instrumentation Laboratory CO · JBQ · Feb 23, 2007 · Hematology

Device Facts

• Record ID: K070301
• Device Name: HEMOSIL ANTITHROMBIN
• Applicant: Instrumentation Laboratory CO
• Product Code: JBQ · Hematology
• Decision Date: Feb 23, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7060
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

HemosIL Antithrombin is an in vitro diagnostic test for the quantitative determination of Antihrombin in human plasma to monitor the administration of heparin in the treatment of thrombosis and as an aid in the diagnosis of thrombophilia (a congenital deficiency of Antithrombin).

Device Story

HemosIL Antithrombin is an in vitro diagnostic test for quantitative measurement of Antithrombin in human plasma. Used in clinical laboratory settings to monitor heparin therapy for thrombosis and assist in diagnosing congenital thrombophilia. The device provides quantitative results to healthcare providers to guide clinical decision-making regarding anticoagulant therapy and patient management. No changes to the underlying assay technology were made in this submission; the modification was limited to the Expected Values section of the product insert to reference published literature for normal ranges.

Clinical Evidence

No clinical data; bench testing only. Evidence consists of literature-based reference ranges for neonates, infants, and children up to age 16, replacing previous internal normal range studies.

Technological Characteristics

In vitro diagnostic assay for Antithrombin III quantitation. No changes to materials, sensing principle, or energy source compared to the predicate device. The modification is limited to labeling (Expected Values).

Indications for Use

Indicated for use as an antithrombin assay (HemosIL Antithrombin) for clinical laboratory testing.

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 (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K070301

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: normal range in the Expected Value Section of the Antithrombin Product Insert

4. Comparison Information (similarities and differences) 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 and up to age 16 years. This approach reinforces the need for each laboratory to establish its own HemosIL Antithrombin 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.

Comments

(Reviewer's Signature)

(Date)

revised: 8/1/03