HemosIL D-Dimer HS 500

K172903 · Instrumentation Laboratory CO · DAP · Nov 22, 2017 · Hematology

Device Facts

• Record ID: K172903
• Device Name: HemosIL D-Dimer HS 500
• Applicant: Instrumentation Laboratory CO
• Product Code: DAP · Hematology
• Decision Date: Nov 22, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7320
• Device Class: Class 2

Intended Use

HemosIL D-Dimer HS 500 is an automated latex enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma on the ACL TOP® Family and ACL TOP Family 50 Series Systems for use, in conjunction with a clinical pretest probability (PTP) assessment model to exclude venous thromboembolism (VTE) in outpatients suspected of deep venous thrombosis (DVT) and pulmonary embolism (PE). For in vitro diagnostic use.

Device Story

HemosIL D-Dimer HS 500 is an in vitro diagnostic assay for quantitative determination of D-dimer in human citrated plasma. Modification involves updating package insert to include peer-reviewed literature regarding association between patient age and D-dimer levels. Device remains unchanged in design, manufacture, performance, and intended use. No verification or validation studies required for labeling update.

Clinical Evidence

No clinical data provided. This is a labeling-only modification based on peer-reviewed literature regarding age-related D-Dimer levels.

Technological Characteristics

Latex-enhanced immunoturbidimetric assay. Reagent: Polystyrene latex particles coated with F(ab')2 monoclonal antibody fragments. Analyzers: ACL TOP Family and ACL TOP Family 50 Series. Sample: Citrated plasma. Detection limit: 203 ng/mL. Linearity: 215 - 128000 ng/mL. Cut-off: 500 ng/mL.

Indications for Use

Indicated for use as an aid in the diagnosis of venous thromboembolism (VTE) in patients suspected of having deep vein thrombosis (DVT) or pulmonary embolism (PE).

Predicate Devices

• HemosIL D-Dimer HS 500 (K090264)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Decision Summary

To: THE FILE

RE: DOCUMENT NUMBER: K172903

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 500 (K090264).
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 information from peer-reviewed literature regarding the association of patient age with D-dimer levels to the HemosIL D-Dimer HS 500 package insert.

Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, methodology, and physical characteristics are located in the 510(k) Summary.

4. 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 (section 10) was conducted in accordance with ISO 14971, Medical devices – Application of risk management to medical devices. Since there are no modificaitons to the design, manufacture, performance characteristics, or intended use of the product, the proposed change to the HemosIL D-Dimer HS 500 package insert sheet has no impact on the safety or effectiveness of the product.
b) Based on the Risk Analysis of the proposed change to the package insert sheet of HemosIL D-Dimer HS 500, no verification or validation studies are required to support the changes and there is no impact on the safety or effectiveness of the product.

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.