HemosIL Silica Clotting Time

K160445 · Instrumentation Laboratory CO · GFO · Mar 16, 2016 · Hematology

Device Facts

• Record ID: K160445
• Device Name: HemosIL Silica Clotting Time
• Applicant: Instrumentation Laboratory CO
• Product Code: GFO · Hematology
• Decision Date: Mar 16, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7925
• Device Class: Class 2

Indications for Use

HemosIL Silica Clotting Time is intended for the detection of Lupus Anticoagulants in human citrated plasma on the IL Coagulation Systems by the use of screening (SCT Screen) and confirmatory (SCT Confirm) reagents sensitized to phospholipid dependent antibodies. For in vitro diagnostic use.

Device Story

HemosIL Silica Clotting Time is an in vitro diagnostic reagent used to detect Lupus Anticoagulants in human plasma; modification involves updating package insert labeling regarding heparin interference; replaces specific heparin reference levels with warning that heparin presence may cause falsely prolonged clotting times; intended for clinical laboratory use; fundamental scientific technology remains unchanged; no physical device modifications; no impact on safety or effectiveness.

Clinical Evidence

No clinical data; bench testing only; no verification or validation studies required due to nature of labeling-only modification.

Technological Characteristics

In vitro diagnostic reagent kit for coagulation testing. Uses phospholipid-sensitized reagents to detect Lupus Anticoagulants via intrinsic pathway activation. Compatible with ACL TOP, ACL Futura, ACL Advance, and ACL ELITE/ELITE PRO analyzer families. Standalone reagent system; no changes to formulation, materials, or hardware.

Indications for Use

Indicated for use as an in vitro diagnostic reagent for the determination of Silica Clotting Time (SCT) in human plasma to aid in the detection of Lupus Anticoagulants (LA).

Regulatory Classification

Identification

A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.

Predicate Devices

• HemosIL Silica Clotting Time (K050221)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIR Decision Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K160445

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: HemosIL Silica Clotting Time (K050221)
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 and package labeling.
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail, demonstrated that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for modification of the Summary and Principle section and the Limitations/Interfering Substances section of the HemosIL Silica Clotting Time insert sheet, in which the heparin interference reference levels was replaced with a statement to indicate that patient samples containing heparin may exhibit falsely prolonged clotting times which could lead to incorrect results.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including labeling, intended use/indication for use, methodology, insert sheet, physical characteristics are located in 510(k) Summary.
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. Since there are no modifications to the design, manufacture, performance characteristics, or intended use of the product, the proposed change to the HemosIL Silica Clotting Time 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 Silica Clotting Time product, no verification or validation studies are required to support the changes and there is on 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.