Hemochron Signature Elite

K193041 · Accriva Diagnostics, Inc. · JPA · Nov 22, 2019 · Hematology

Device Facts

• Record ID: K193041
• Device Name: Hemochron Signature Elite
• Applicant: Accriva Diagnostics, Inc.
• Product Code: JPA · Hematology
• Decision Date: Nov 22, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Indications for Use

The Hemochron™ Signature Elite Whole Blood Microcoagulation System is a battery-operated, hand-held instrument that performs individual point-of-care coagulation tests on fresh or citrated whole blood. These tests include: Activated Clotting Time (ACT+ and ACT-LR), Activated Partial Thromboplastin Time (APTT and APTT Citrate), and Prothrombin Time (PT and PT Citrate). The system is intended to be used with test cuvettes that are available from the manufacturer. For in vitro Diagnostic Use. For professional use. Rx only.

Device Story

Hemochron Signature Elite is a multipurpose system for in vitro coagulation studies. Device modification (v2.3 to v2.4) updates instrument heater control loop to maintain tighter temperature regulation (37±1°C) within cuvette test channel during assay test phase. System operates in clinical settings to provide coagulation monitoring. Healthcare providers use output to assess patient coagulation status and guide clinical decision-making.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing and software verification/validation for the version update.

Technological Characteristics

Multipurpose system for in vitro coagulation studies. Modification involves software-controlled heater plate and cuvette test channel temperature regulation (37±1°C).

Indications for Use

Indicated for professional point-of-care coagulation testing (ACT, APTT, PT) using fresh or citrated whole blood in clinical settings.

Regulatory Classification

Identification

A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

Special Controls

*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Predicate Devices

• Hemochron™ Signature Elite (K050016)

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

K193041

B Applicant

Accriva Diagnostics, Inc.

C Proprietary and Established Names

Hemochron Signature Elite

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JPA | Class II | 21 CFR 864.5425 - Multipurpose System For In Vitro Coagulation Studies | 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 (Hemochron Signature Elite).
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.
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.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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This change was for a device software modification from version 2.3 to version 2.4 to allow the instrument's heater control loop to have tighter control over the temperature within the cuvette test channel to ensure both the heater plate and the cuvette test channel maintain appropriate temperature (37±1°C) for the duration of the test phase of the assay.

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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