HemosIL Factor XII Deficient Plasma

K180486 · Instrumentation Laboratory CO · GJT · Mar 22, 2018 · Hematology

Device Facts

• Record ID: K180486
• Device Name: HemosIL Factor XII Deficient Plasma
• Applicant: Instrumentation Laboratory CO
• Product Code: GJT · Hematology
• Decision Date: Mar 22, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7290
• Device Class: Class 2

Indications for Use

Human plasma immunodepleted of factor XII for the quantitative determination of factor XII (FXII) activity in citrated plasma, based on activated partial thromboplastin time (APTT) assay, on IL Coagulation Systems.

Device Story

HemosIL Factor XII Deficient Plasma; artificially depleted plasma; used for quantitative determination of Factor XII activity in human citrated plasma via clotting method. Operates on ACL TOP Family and ACL TOP Family 50 Series coagulation systems. Modification involves updating recommended on-board stability from 24 hours to 6 hours at 15°C. Used in clinical laboratory settings by trained personnel. Output provides Factor XII activity levels to assist in coagulation disorder diagnosis and management.

Clinical Evidence

Bench testing only. Verification testing conducted in accordance with CLSI EP25-A to establish the modified on-board instrument stability claim.

Technological Characteristics

Human plasma immunodepleted of factor XII. Functional clotting assay (APTT). Compatible with ACL TOP Family and ACL TOP Family 50 Series coagulation analyzers. No changes to formulation, materials, or data reduction software.

Indications for Use

Indicated for the quantitative determination of Factor XII activity in human citrated plasma using the clotting method on IL Coagulation Systems.

Predicate Devices

• HemosIL Factor XII Deficient Plasma (K043459)

Submission Summary (Full Text)

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SPECIAL 510(K): DEVICE MODIFICATION OIR DECISION SUMMARY

510(k) Number: K180486

This 510(k) submission contains information/data on modifications made to the applicant’s own class II 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 applicant’s previously cleared device: HemosIL Factor XII Deficient Plasma, K043459.
2. Applicant’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 (labeling changes are permitted as long as they do not affect the intended use).
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 an update to the recommended on-board stability for HemosIL Factor XII Deficient Plasma on the ACL TOP Family and ACL TOP Family 50 Series from 24 hours to 6 hours at 15°C.

4. Comparison Information (similarities and differences) to applicant’s legally marketed predicate device including, labeling, intended use, physical characteristics.
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 and found to be satisfactory.

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 applicant’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 applicant 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.