PF4 IgG assay

K201311 · Immucor Gti Diagnostics, Inc. · LCO · Jun 18, 2020 · Hematology

Device Facts

• Record ID: K201311
• Device Name: PF4 IgG assay
• Applicant: Immucor Gti Diagnostics, Inc.
• Product Code: LCO · Hematology
• Decision Date: Jun 18, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7695
• Device Class: Class 2

Indications for Use

PF4 IgG is a qualitative screening assay for the detection of heparin associated IgG antibodies in human serum or plasma.

Device Story

PF4 IgG is an ELISA-based diagnostic assay for detecting IgG antibodies against PF4/polyanion complexes (e.g., PF4/PVS) in human serum or plasma. Used in clinical laboratories, the assay involves adding patient samples to microwells coated with immobilized PF4/PVS complexes. If present, specific antibodies bind to the target; unbound components are washed away. An alkaline phosphatase-labeled anti-human IgG conjugate is added, followed by a substrate (PNPP). The reaction is stopped with a buffered EDTA solution, and optical density is measured via spectrophotometer. Results are qualitative (positive/negative). The assay aids in identifying patients with HIT, an adverse reaction to heparin therapy characterized by thrombocytopenia and potential thrombosis. The device provides clinicians with diagnostic information to support clinical decision-making regarding heparin therapy management.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by design control activities, risk analysis, and verification/validation testing of the modified components.

Technological Characteristics

Immunoassay; utilizes human serum/plasma samples. Positive control contains human serum, bovine albumin, 0.1% NaN3, and chimeric (mouse Fab/Human Fc) monoclonal antibody. Stopping solution is buffered EDTA. Fundamental technology unchanged from predicate.

Indications for Use

Indicated for qualitative screening of heparin-associated IgG antibodies in human serum or plasma. These antibodies are commonly found in patients with Heparin Induced Thrombocytopenia (HIT).

Regulatory Classification

Identification

A platelet factor 4 radioimmunoassay is a device used to measure the level of platelet factor 4, a protein released during platelet activation by radioimmunoassay. This device measures platelet activiation, which may indicate a coagulation disorder, such as myocardial infarction or coronary artery disease.

Predicate Devices

• PF4 IgG assay (K201311 - previously cleared device)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K201311

B Applicant

Immucor GTI Diagnostics, Inc.

C Proprietary and Established Names

PF4 IgG assay

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| LCO | Class II | 21 CFR 864.7695 - Platelet Factor 4 Radioimmunoassay | HE - Hematology |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device (GENETIC TESTING INSTITUTE, GTI).
2. Submitter's statement that the INDICATIONS FOR USE/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. (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

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for a Positive Serum Control raw material from human serum containing bovine albumin 0.1% NaN3 to human serum containing bovine albumin 0.1% NaN3 PLUS a chimeric (mouse Fab/Human Fc) monoclonal antibody, addition of plasma as a sample type, and a Stopping Solution changed from 3M NaOH to a buffered EDTA solution.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and 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.

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 device.

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