HemosIL D-Dimer HS

K151534 · Instrumentation Laboratory CO · DAP · Jul 6, 2015 · Hematology

Device Facts

• Record ID: K151534
• Device Name: HemosIL D-Dimer HS
• Applicant: Instrumentation Laboratory CO
• Product Code: DAP · Hematology
• Decision Date: Jul 6, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7320
• Device Class: Class 2

Indications for Use

The HemosIL D-Dimer HS is an automated latex immunoturbidimetric assay for the quantitative determination of D-Dimer in human citrated plasma on the ACL TOP family of instruments. The assay is used as an aid in the diagnosis of deep vein thrombosis (DVT) and pulmonary embolism (PE).

Device Story

HemosIL D-Dimer HS is an automated latex-enhanced immunoturbidimetric assay used in clinical laboratories on ACL TOP analyzers. The device utilizes polystyrene latex particles coated with F(ab')2 fragments of monoclonal antibodies specific to the D-Dimer domain. When patient citrated plasma is mixed with the latex reagent and reaction buffer, D-Dimer causes particle agglutination. The analyzer measures the decrease in transmitted light, which is directly proportional to the D-Dimer concentration in the sample. Results are used by clinicians in conjunction with pretest probability (PTP) assessment models to rule out VTE in patients suspected of DVT or PE. The device provides quantitative data to assist in clinical decision-making, potentially reducing the need for unnecessary imaging studies.

Clinical Evidence

No clinical data; bench testing only. Modification involves labeling update based on peer-reviewed literature; no changes to device performance or analytical characteristics.

Technological Characteristics

Latex-enhanced immunoturbidimetric assay. Reagent consists of polystyrene latex particles coated with F(ab')2 monoclonal antibody fragments. Analyzers: ACL TOP Family. Sample type: Citrated plasma. Detection limit: 21 ng/mL. Linearity: 150 – 69000 ng/mL. Cut-off: 230 ng/mL.

Indications for Use

Indicated for use as an aid in the diagnosis of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients suspected of having these conditions.

Predicate Devices

• HemosIL D-Dimer HS (K070927)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Decision Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K151534

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: HemosIL D-Dimer HS, K070927.
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 the addition of general information from peer-reviewed literature regarding the association of patient age with D-Dimer levels to the HemosIL D-Dimer HS product insert sheet.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, sample type, instrument, and performance claims.
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. The Risk Analysis was conducted in accordance with ISO 14971, Medical Devices—Application of Risk Management to Medical Devices, and following the manufacturer's internal risk management procedure. There is no additional risk associated with the changes (page 6 of Section 10, Risk Management Report).
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. No verification and/or validation activities were required (page 6 of Section 10, Risk Management Report).

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.